Glossary

Clinical trial and PM nomenclature with chapter locations.

483Short-hand for Form FDA 483.
Common inspection shorthand; PMs should understand it as an observation document, not as a final agency enforcement decision.Ch. 24

ACRPAssociation of Clinical Research Professionals.
Use it as a professional-development and clinical research operations reference context.Ch. 27

Action itemA specific follow-up task with an owner and due date.
Converts discussion into trackable work.Ch. 1, Ch. 4, Ch. 25

ActivationPoint when a site is approved and ready to begin trial activity, often screening or enrollment.
Tracks whether startup work has become usable site capacity.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 16, Ch. 19, Ch. 21, Ch. 22, Ch. 24, Ch. 27, Ch. 28

active controlAn active control is an existing active treatment used as the comparator.
Use this term when reading or managing chapter situations where active control affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 7, Ch. 9, Ch. 10

ADaMAnalysis Data Model.
CDISC data standard used for analysis datasets.Ch. 15, Ch. 17

Adaptive designDesign allowing prospectively planned changes based on accumulating data.
Requires governance, simulations, DMC/IDMC coordination, and operational control.Ch. 8, Ch. 9

AdjudicationStructured review by qualified reviewers or a committee to classify events, endpoints, or outcomes.
PM tracks charters, packets, timelines, queries, independence, and evidence flow.Ch. 2, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 11, Ch. 24, Ch. 26

AE/SAE / adverse event and serious adverse eventAdverse event is any unfavorable medical occurrence in a participant; serious adverse event meets seriousness criteria such as death, life-threatening event, hospitalization, disability, congenital anomaly, or another important medical event.
PMs track reporting workflow, reconciliation, site training, vendor handoffs, aging metrics, and escalation evidence while medical assessment remains with qualified safety and medical owners.Ch. 2, Ch. 3, Ch. 6, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28

ALCOAAttributable, Legible, Contemporaneous, Original, Accurate.
Data integrity memory aid; often extended with complete, consistent, enduring, and available.Ch. 20

AllocationAllocation means the assignment of a participant to one of those arms.
Use this term when reading or managing chapter situations where allocation affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 7

Allocation concealmentAllocation concealment means the next assignment cannot be known or predicted before the participant is enrolled or assigned.
Use this term when reading or managing chapter situations where allocation concealment affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 7

AmendmentFormal change to an approved protocol or related controlled document.
PM coordinates impact assessment, approvals, rollout, training, budget, timeline, and version control.Ch. 1, Ch. 2, Ch. 3, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 28

Analysis populationDefined participant set used for a statistical analysis.
PM understands how protocol conduct, eligibility, treatment exposure, and missing data can affect interpretability.Ch. 1, Ch. 15, Ch. 17, Ch. 26

armAn arm is a protocol-specified group receiving an intervention, comparator, dose, or control strategy.
Use this term when reading or managing chapter situations where arm affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 5, Ch. 7, Ch. 8, Ch. 10, Ch. 11, Ch. 13, Ch. 14, Ch. 15

Assay sensitivityIf the trial is designed for noninferiority or equivalence, the team must preserve assay sensitivity.
Use this term when reading or managing chapter situations where assay sensitivity affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 7, Ch. 9

AssumptionSomething treated as true for planning until confirmed or disproven.
Tracks fragile planning beliefs such as site enrollment rates, vendor capacity, or country timelines.Ch. 2, Ch. 4, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 27, Ch. 29, Ch. 30

assumption registerLauren created a DIAB-220 assumption register.
Use this term when reading or managing chapter situations where assumption register affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10, Ch. 11

AuditIndependent or internal review of processes, records, systems, or compliance against requirements.
PM prepares evidence, owners, issue history, and follow-up actions with Quality leadership.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 7, Ch. 14, Ch. 15, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 26

Audit trailSystem record of data changes, users, timestamps, and reasons.
Supports data integrity and inspection reconstruction.Ch. 5, Ch. 7, Ch. 14, Ch. 15, Ch. 24, Ch. 26

BABioavailability.
Relevant to pharmacokinetic and generic/bioequivalence studies.Ch. 6, Ch. 7, Ch. 16, Ch. 17, Ch. 18, Ch. 20, Ch. 24

BA/BEBioavailability/bioequivalence.
Important for BIOSIM-701 and generic-industry project operations.Ch. 6, Ch. 17, Ch. 18, Ch. 20, Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 19, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

BaselineThe approved version of scope, schedule, cost, or plan.
Used to compare actual trial performance against the authorized plan.Ch. 3, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 19, Ch. 21, Ch. 23, Ch. 24, Ch. 26, Ch. 27

BEBioequivalence.
Used to show a generic product is equivalent to a reference product within accepted criteria.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

BiasSystematic error that can distort trial results.
PM protects against operational sources of bias such as unblinding, inconsistent assessment, or missing data.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 12, Ch. 17, Ch. 20

BIMOBioresearch Monitoring.
FDA inspection and compliance program area relevant to clinical investigations.Ch. 24

biomarkerA biomarker is a measurable biological feature, such as a gene variant, lab value, protein, imaging signal, or physiological measure, that may help define risk, disease type, response, or eligibility.
Use this term when reading or managing chapter situations where biomarker affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 6, Ch. 8, Ch. 9, Ch. 11

BlindingKeeping treatment assignment, assessment expectations, or other bias-sensitive information unknown to the parties who should not know it, such as participants, investigators, site staff, endpoint assessors, central readers, sponsor study team members, data reviewers, statisticians, vendors, or committee members.
PMs protect the blind through IRT/RTSM setup, IP packaging, randomization access, lab-result handling, central versus local lab workflows, endpoint adjudication, safety escalation, data-transfer roles, unblinding procedures, and communication discipline. Blinding may mean different things in drug, device, imaging, lab-driven, open-label, blinded-assessor, decentralized, oncology, vaccine, and BA/BE trials.Ch. 1, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 12, Ch. 14, Ch. 17, Ch. 18

Block randomizationBlock randomization is a method that helps maintain balance within groups of assignments, but block size and sequence details must be restricted because predictability can threaten allocation concealment.
Use this term when reading or managing chapter situations where block randomization affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 7

BMJBritish Medical Journal.
Use it when the book references publication or reporting examples from medical literature.Ch. 7

budget negotiationA budget negotiation is the process of agreeing what trial work will be paid for and at what rates.
Use this term when reading or managing chapter situations where budget negotiation affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

Budget varianceDifference between planned, actual, committed, or forecast cost.
Shows whether trial spend reflects scope change, delay, rescue work, or underperformance.Ch. 19, Ch. 21

Burn rateSpeed at which the project is spending money.
Helps interpret whether the trial can sustain the current plan.Ch. 19, Ch. 21, Ch. 29

CAPACorrective and preventive action: a structured response to significant or recurring problems that corrects the immediate issue and reduces the chance of recurrence.
PMs track root cause, correction, prevention, owner, due date, quality review, effectiveness check, and related governance or inspection commitments.Ch. 1, Ch. 2, Ch. 3, Ch. 14, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29

CAPA/TMFCorrective and preventive action / trial master file shorthand.
Use it when a correction must be both effective in operations and reconstructable in inspection records.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

CAPMCertified Associate in Project Management.
Entry-level PMI credential sometimes referenced for PM career development.Ch. 27

Case report form / CRFTool for collecting protocol-required trial data.
Drives EDC design, edit checks, monitoring, and data cleaning.Ch. 3, Ch. 15

CausalityMedical judgment about whether an event may be related to an intervention or other cause.
PM routes causality assessment to qualified medical/safety owners and tracks process completion.Ch. 3, Ch. 5, Ch. 14, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 23, Ch. 24, Ch. 30

CDISCClinical Data Interchange Standards Consortium.
Provides clinical research data standards such as SDTM and ADaM.Ch. 15, Ch. 17

Central labA laboratory used to process or analyze samples under standardized methods across sites or regions.
PMs manage kit supply, sample logistics, accessioning, turnaround, data transfers, alerts, reconciliation, chain of custody, and whether central results are blinded or shared with local care teams.Ch. 2, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 11, Ch. 12, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 24, Ch. 26, Ch. 27, Ch. 29

CFRCode of Federal Regulations.
U.S. regulatory rules referenced in clinical research compliance.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26

Change controlFormal process for evaluating and approving changes.
Controls amendments, vendor scope changes, system changes, timeline resets, and budget impacts.Ch. 3, Ch. 18, Ch. 19, Ch. 22

Change orderA contract or scope adjustment that changes work, cost, or timing.
Used with CROs and vendors when assumptions or work packages change.Ch. 2, Ch. 3, Ch. 4, Ch. 18, Ch. 19, Ch. 21, Ch. 28

Charter / PM role charterA document defining project purpose, authority, scope, success measures, and assumptions.
Helps clarify why the trial exists and what the PM is authorized to manage.Ch. 1, Ch. 4, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 16, Ch. 23, Ch. 26, Ch. 30

CHMPCommittee for Medicinal Products for Human Use.
EMA committee relevant to EU medicines evaluation.Ch. 12

ClarificationClarification is an explanation that helps people understand existing requirements without changing the protocol's meaning or conduct.
Use this term when reading or managing chapter situations where clarification affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 11, Ch. 15, Ch. 21, Ch. 24, Ch. 28, Ch. 29

clinical development plan (CDP)A clinical development plan (CDP) is the program-level plan that connects the studies and evidence needed across development: clinical pharmacology, dose selection, proof of concept, confirmatory evidence, safety, special populations, regional needs, pediatric planning when applicable, and postmarketing questions.
Use this term when reading or managing chapter situations where clinical development plan (cdp) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10

Clinical monitoringOversight of site conduct, source records, protocol compliance, and participant protection.
Helps identify deviations, data issues, consent issues, and site performance problems.Ch. 12

Clinical operationsFunction responsible for operational conduct of clinical trials.
Often owns site management, monitoring strategy, activation, enrollment support, and field execution.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 13, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 22, Ch. 25, Ch. 26, Ch. 28, Ch. 30

Clinical study report / CSRFormal report summarizing trial design, conduct, analysis, and results.
Major closeout and submission deliverable.Ch. 1, Ch. 3, Ch. 4, Ch. 7, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 22, Ch. 25, Ch. 26, Ch. 27

Clinical supplyPlanning, packaging, labeling, distributing, reconciling, returning, or destroying investigational product.
Protects dosing continuity, accountability, temperature control, and blind integrity.Ch. 1, Ch. 4, Ch. 12, Ch. 26, Ch. 27

clinical trial agreementA clinical trial agreement is the contract between the sponsor or CRO and the site or institution.
Use this term when reading or managing chapter situations where clinical trial agreement affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

CohortGroup of participants sharing defined characteristics or study assignment.
Used in design, enrollment tracking, subgroup planning, and analysis interpretation.Ch. 5, Ch. 6, Ch. 8, Ch. 19

Communication planPlan defining audience, message, owner, channel, cadence, and escalation path.
Keeps sites, vendors, functions, leadership, and regulators aligned.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 10, Ch. 13, Ch. 14, Ch. 16, Ch. 17, Ch. 18, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 29, Ch. 30

ComparatorControl treatment or reference against which the investigational product is compared.
Affects design, supply, blinding, endpoints, and interpretation.Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 14, Ch. 17

CompletionCompletion means the participant finished the protocol-defined participation, not merely that the study team stopped tracking them.
Use this term when reading or managing chapter situations where completion affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 6, Ch. 8, Ch. 9, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 16, Ch. 18, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 26, Ch. 28, Ch. 29

concept sheetA protocol synopsis or concept sheet is a short structured summary used before the full protocol.
Use this term when reading or managing chapter situations where concept sheet affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10, Ch. 11

Confidence intervalRange of values compatible with observed data under a statistical method.
Helps interpret precision, not just whether a p-value crossed a threshold.Ch. 17

ConfoundingConfounding is a specific problem where the relationship between an exposure and an outcome is mixed with the effect of another factor.
Use this term when reading or managing chapter situations where confounding affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 5, Ch. 11

ConstraintA limit on time, cost, scope, quality, resources, risk, or authority.
Helps the PM explain tradeoffs rather than only reporting pressure.Ch. 16, Ch. 19

contract research organization (CRO)A contract research organization (CRO) is an external organization that may perform trial services for the sponsor.
Use this term when reading or managing chapter situations where contract research organization (cro) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 9, Ch. 10, Ch. 11, Ch. 12

Control groupGroup used for comparison with the investigational intervention.
Essential for interpreting treatment effect.Ch. 3, Ch. 7, Ch. 9

CRAClinical research associate.
Monitor who supports and oversees site conduct.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 12, Ch. 14, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 24, Ch. 27

CRCClinical research coordinator.
Site staff member coordinating participant visits, data, documents, and study procedures.Ch. 27

Critical pathThe sequence of dependent work that determines the project finish date.
Identifies the activities most likely to delay startup, enrollment, database lock, or submission.Ch. 1, Ch. 4, Ch. 6, Ch. 9, Ch. 12, Ch. 15, Ch. 16, Ch. 19, Ch. 21, Ch. 22, Ch. 23, Ch. 27, Ch. 29

CROContract research organization: an external organization delegated to perform trial activities such as monitoring, site management, data support, safety processing, regulatory operations, or project operations.
PMs manage CRO scope, SOW assumptions, KPIs/KRIs, issue escalation, deliverable quality, staffing, governance, and sponsor oversight evidence; delegation changes execution but not sponsor accountability.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Crossover designDesign where participants receive more than one treatment in sequence.
Common in BA/BE or PK studies and requires washout, sequence, and timing control.Ch. 7

CSRClinical study report.
Major closeout and submission deliverable summarizing trial design, conduct, analysis, and results.Ch. 3, Ch. 4, Ch. 7, Ch. 11, Ch. 12, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 22, Ch. 25, Ch. 26, Ch. 27

CTAClinical trial application or clinical trial agreement, depending on context.
Must be defined by context because both meanings are common.Ch. 2, Ch. 12, Ch. 27

CTMSClinical trial management system.
Tracks operational trial information such as sites, milestones, monitoring, and study status.Ch. 1

CTQ / critical-to-quality factorA feature of the trial whose failure would meaningfully threaten participant protection, rights, safety, data reliability, interpretability, or regulatory credibility.
PMs use CTQs to focus feasibility review, monitoring strategy, vendor oversight, QTL/KRI selection, deviation review, inspection readiness, and leadership escalation on what matters most.Ch. 1, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 28, Ch. 29, Ch. 30

Data cleaningProcess of identifying and resolving data issues before analysis.
PM tracks query aging, reconciliation, coding, listings, and lock readiness.Ch. 1, Ch. 3, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 18, Ch. 19, Ch. 21, Ch. 26, Ch. 28

Data cutDefined extract or snapshot of data for review or analysis.
Must be versioned and controlled.Ch. 4, Ch. 8, Ch. 9, Ch. 17, Ch. 26

Data integrityData are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available as applicable.
PM protects integrity through systems, process, documentation, and issue escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 14, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

data monitoring committee (DMC)A data monitoring committee (DMC) is an independent or semi-independent committee that reviews accumulating trial data, often for safety and sometimes for efficacy or futility, according to a predefined charter.
Use this term when reading or managing chapter situations where data monitoring committee (dmc) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 9

data provenanceThe phrase data provenance means knowing where data came from, how they were captured, how they were transformed, who handled them, what rules were applied, and whether the chain can be inspected or explained.
Use this term when reading or managing chapter situations where data provenance affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 5

Data reconciliationComparing related data across systems or sources.
Used for safety, lab, IRT, EDC, coding, and vendor transfer alignment.Ch. 11, Ch. 14, Ch. 26

Data transfer specificationDocument defining transfer fields, format, timing, rules, and acceptance criteria.
Prevents vendor/data handoff failures.Ch. 18

Database lockPoint when the cleaned clinical database is finalized for analysis.
Major milestone requiring query closure, reconciliation, coding, listings, and approvals.Ch. 1, Ch. 3, Ch. 4, Ch. 6, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 21, Ch. 22, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29

DCTDecentralized clinical trial.
Trial model using remote or technology-enabled activities outside traditional site visits.Ch. 8, Ch. 9, Ch. 17, Ch. 18, Ch. 20, Ch. 30

Decision logRecord of decisions, rationale, owner, evidence, dissent, residual risk, and follow-up.
Protects governance memory and inspection defensibility.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Decision memoConcise written recommendation with facts, options, risks, owners, and requested decision.
Moves leadership conversations from vague concern to governed action.Ch. 1, Ch. 2, Ch. 6

DependencyA relationship where one task, decision, or deliverable depends on another.
Links protocol approval, vendor readiness, site activation, data transfers, and analysis timing.Ch. 1, Ch. 2, Ch. 4, Ch. 11, Ch. 12, Ch. 15, Ch. 16, Ch. 17, Ch. 22, Ch. 23, Ch. 24, Ch. 29

depotA depot is a storage and distribution location for study product.
Use this term when reading or managing chapter situations where depot affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 4, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 18, Ch. 19

design rationaleA design rationale is the documented explanation of why a design was chosen for a specific question, population, evidence need, ethical context, and operating reality.
Use this term when reading or managing chapter situations where design rationale affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8, Ch. 9

DeviationDeparture from protocol, procedure, or requirement.
PM tracks trends, impact, owners, correction, and escalation.Ch. 1, Ch. 3, Ch. 6, Ch. 11, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 24, Ch. 26, Ch. 28, Ch. 30

digital endpointA digital endpoint is an endpoint measured using digital health technology.
Use this term when reading or managing chapter situations where digital endpoint affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8

DiscontinuationDiscontinuation means stopping a particular study intervention or stopping participation in some part of the study as defined by the protocol.
Use this term when reading or managing chapter situations where discontinuation affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 20, Ch. 22, Ch. 23, Ch. 26

DMCData monitoring committee.
Independent committee reviewing accumulating data in some trials.Ch. 1, Ch. 8, Ch. 9, Ch. 23, Ch. 26

Dose escalationPlanned increase in dose across cohorts or participants.
Requires safety review, stopping rules, governance, and clear decision rights.Ch. 6, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26

dosedTreated or dosed means the participant actually received the intervention or comparator.
Use this term when reading or managing chapter situations where dosed affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 4, Ch. 7

Drug accountabilityDrug accountability means tracking study product from shipment through receipt, storage, dispensing, return, reconciliation, and destruction as required.
Use this term when reading or managing chapter situations where drug accountability affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 6, Ch. 12, Ch. 14, Ch. 15, Ch. 20, Ch. 26

dummyA dummy is a matching placebo or matching treatment form used to preserve blinding [ICH E9].
Use this term when reading or managing chapter situations where dummy affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 7

E10ICH E10 shorthand for choice of control group and related clinical trial design considerations.
Use it when comparator, placebo, active control, or assay sensitivity choices affect operational planning.Ch. 7, Ch. 9

E17ICH E17 shorthand for general principles for planning and design of multi-regional clinical trials.
Use it when countries, regions, populations, and regulatory expectations affect trial feasibility and interpretation.Ch. 10

E9/E9Shorthand reference to ICH E9 and E9(R1) statistical principles and estimand thinking.
Use it when randomization, blinding, endpoints, estimands, intercurrent events, and analysis interpretation affect PM decisions.Ch. 23, Ch. 25, Ch. 26, Ch. 30, Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 18, Ch. 20, Ch. 22

eCOAElectronic clinical outcome assessment system used to collect patient-reported, clinician-reported, observer-reported, or performance outcome data electronically.
PMs manage device/app readiness, training, help-desk trends, compliance, missingness, translations, backups, vendor tickets, and endpoint impact.Ch. 3, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 26, Ch. 27, Ch. 28, Ch. 29

eConsentElectronic informed consent.
Requires validated systems, version control, participant comprehension, and documentation.Ch. 8, Ch. 9

eCRFElectronic case report form.
Electronic version of a CRF in EDC.Ch. 3

EDC / electronic data captureThe system used to collect, query, clean, review, and export protocol-required clinical trial data.
PMs track EDC build, UAT, edit checks, access, training, query aging, data transfer, reconciliation, audit trails, and database-lock readiness.Ch. 1, Ch. 2, Ch. 3, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 26, Ch. 27

Edit checksEdit checks are programmed or manual checks that help identify missing, inconsistent, or illogical data.
Use this term when reading or managing chapter situations where edit checks affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 10, Ch. 11, Ch. 12, Ch. 15, Ch. 22

effectiveSubmitted, approved, implemented, and effective are four more words that require discipline.
Use this term when reading or managing chapter situations where effective affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 22, Ch. 24, Ch. 28

EHRElectronic health record.
Data source for clinical care records and some real-world evidence work.Ch. 5

EIREstablishment Inspection Report.
FDA inspection report document.Ch. 24

Eligibility criteriaInclusion and exclusion rules defining who can enter the study.
Drives feasibility, screen failures, recruitment, amendments, and data interpretability.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 9, Ch. 10, Ch. 11, Ch. 13, Ch. 16

EMAEuropean Medicines Agency.
EU medicines regulatory agency.Ch. 1, Ch. 2, Ch. 5, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12

Emergency unblindingEmergency unblinding [ICH E9] means revealing assignment when needed for participant care or safety under the protocol-defined process.
Use this term when reading or managing chapter situations where emergency unblinding affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 4, Ch. 7, Ch. 8, Ch. 23

EndpointA prespecified measurement or event used to evaluate whether the trial objective has been met; endpoints may be primary, secondary, exploratory, safety, pharmacokinetic, pharmacodynamic, patient-reported, imaging-based, laboratory-based, event-driven, or adjudicated.
PMs protect endpoint credibility by aligning protocol procedures, SOA timing, vendor setup, central/local lab processes, site training, visit windows, eCOA/EDC capture, adjudication, data cleaning, missing-data prevention, and statistical interpretation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29

endpoint assessorAn endpoint assessor is the person or group evaluating an outcome measure.
Use this term when reading or managing chapter situations where endpoint assessor affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 7, Ch. 9

Endpoint hierarchyFDA guidance on multiple endpoints supports the discipline of endpoint hierarchy and careful interpretation when many outcomes are evaluated.
Use this term when reading or managing chapter situations where endpoint hierarchy affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10, Ch. 11, Ch. 17

EndpointsPlanned measurements used to assess study objectives.
PM tracks whether operational conduct protects the measurements the trial depends on.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 14, Ch. 15, Ch. 17, Ch. 18, Ch. 21, Ch. 22, Ch. 25, Ch. 27, Ch. 30

EnrichmentEnrichment means focusing enrollment on a subgroup more likely to benefit or more relevant to the question.
Use this term when reading or managing chapter situations where enrichment affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8, Ch. 9, Ch. 10

EnrollmentProcess of enrolling eligible participants into a study.
Core execution metric that must be interpreted with screen failures, site activation, retention, and feasibility.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

ePROElectronic patient-reported outcome.
Electronic capture of outcomes reported directly by participants.Ch. 1, Ch. 2, Ch. 3

Escalation pathDefined route for unresolved or high-risk issues to reach the right authority.
Prevents important trial risks from staying trapped in status meetings.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 10, Ch. 13, Ch. 14, Ch. 16, Ch. 18, Ch. 25, Ch. 29

Essential documentsEssential documents are records that individually and collectively permit evaluation of trial conduct and data quality.
Use this term when reading or managing chapter situations where essential documents affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 2, Ch. 3, Ch. 10, Ch. 11, Ch. 12

EstimandPrecise description of the treatment effect to be estimated.
Helps align objective, endpoint, intercurrent events, population, and summary measure.Ch. 1, Ch. 3, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 17, Ch. 22, Ch. 26

Ethics approvalEthics approval means the IRB or IEC has approved the study materials required for the site or country to proceed under its rules.
Use this term when reading or managing chapter situations where ethics approval affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

eTMFElectronic trial master file.
Electronic system for managing essential trial documents.Ch. 1, Ch. 3, Ch. 26

Evidence packageOrganized set of documents, data, chronologies, decisions, and ownership records.
Used for governance, inspection, rescue, and closeout.Ch. 21, Ch. 23, Ch. 24, Ch. 26

Exclusion criteriaCharacteristics that prevent participation.
Protects participants and science but can create screen-failure risk.Ch. 3, Ch. 10, Ch. 11

ExpectednessSafety assessment of whether an event is expected based on reference safety information.
PM tracks the assessment pathway but does not make the determination.Ch. 3, Ch. 18, Ch. 23

ExpiryExpiry is the date after which product should not be used.
Use this term when reading or managing chapter situations where expiry affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 4, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 14

Exploratory endpointAn endpoint intended to explore signals, mechanisms, biomarkers, patient experience, or future hypotheses rather than serve as the main confirmatory claim.
PMs still protect collection quality, consent scope, vendor readiness, and data traceability because exploratory data may shape future protocols, investment decisions, or scientific strategy.Ch. 6, Ch. 10

FDAU.S. Food and Drug Administration.
U.S. health authority for drugs, biologics, devices, and clinical research oversight.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 29, Ch. 30

FDAAAFDA Amendments Act.
U.S. law relevant to ClinicalTrials.gov registration/results requirements.Ch. 26

FeasibilityFeasibility means whether the study can realistically be conducted as designed.
Use this term when reading or managing chapter situations where feasibility affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

FindingAudit or inspection concern, observation, deficiency, or noncompliance item.
PM tracks factual response, owner, due date, corrective action, preventive action, and closure evidence.Ch. 15, Ch. 20, Ch. 21, Ch. 24

FMVFair market value.
Used in budgeting, site payments, and compliance review.Ch. 19

Form FDA 1572Form FDA 1572 is a U.S.
Use this term when reading or managing chapter situations where form fda 1572 affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

Form FDA 483U.S. FDA form listing inspectional observations when investigators observe conditions that may constitute regulatory violations.
PM helps organize evidence, owners, and response timelines under Quality and Regulatory leadership.Ch. 24

FPIFirst patient in.
Startup-to-execution milestone showing the first participant has entered the trial.Ch. 12

FTEFull-time equivalent.
Estimates resource capacity across Clinical Operations, Data, Safety, Statistics, vendors, or contractors.Ch. 19

FutilityFutility means the data suggest the trial or arm is unlikely to achieve its objective if it continues as planned.
Use this term when reading or managing chapter situations where futility affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 8, Ch. 9, Ch. 26

GCPGood Clinical Practice.
International ethical and quality standard for designing, conducting, recording, and reporting trials.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 11, Ch. 12, Ch. 22, Ch. 24, Ch. 25, Ch. 27, Ch. 30

GeneralizabilityGeneralizability means how well findings apply beyond the exact study population and setting.
Use this term when reading or managing chapter situations where generalizability affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 6, Ch. 9, Ch. 10, Ch. 25

go/no-go decisionA go/no-go decision is a planned decision about whether to continue, stop, modify, or redirect a program or study based on defined evidence and judgment.
Use this term when reading or managing chapter situations where go/no-go decision affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10, Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 11, Ch. 12, Ch. 14, Ch. 17, Ch. 20, Ch. 21

GovernanceStructured decision-making forum and authority model.
Used when risk, budget, scope, timeline, or participant protection exceeds routine PM authority.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

green lightA site activation or green light is sponsor or CRO authorization that a site has met predefined readiness criteria well enough to begin trial activities such as screening or enrollment.
Use this term when reading or managing chapter situations where green light affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

health authorityA regulator or health authority is not a project team member.
Use this term when reading or managing chapter situations where health authority affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 24

HEORHealth economics and outcomes research.
Use it when a project examines value, utilization, treatment patterns, access, cost, patient outcomes, or payer-relevant evidence.Ch. 5

HHSU.S. Department of Health and Human Services.
U.S. department associated with human-subject protections and OHRP.Ch. 1, Ch. 2, Ch. 5

HIPAAHealth Insurance Portability and Accountability Act.
U.S. privacy law relevant to protected health information.Ch. 5

ICF updateAn ICF update is a change to the informed consent [FDA Informed Consent 2023] form, often needed when the protocol, risk information, procedures, or participant-facing language changes.
Use this term when reading or managing chapter situations where icf update affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3

ICHInternational Council for Harmonisation.
Develops harmonized guidelines for medicines, including GCP and statistical principles.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

ICH E2AICH guideline on clinical safety data management and expedited reporting.
Supports safety reporting concepts.Ch. 1, Ch. 23

ICH E2BICH guideline family for electronic transmission of individual case safety reports.
Relevant to safety data exchange.Ch. 23

ICH E2FICH guideline on development safety update reports.
Relevant to aggregate safety reporting during development.Ch. 23

ICH E3ICH guideline on clinical study report structure and content.
Supports CSR expectations.Ch. 1, Ch. 15, Ch. 26

ICH E6(R3)ICH Good Clinical Practice guideline revision.
Core reference for participant protection, sponsor oversight, quality, documentation, and trial conduct.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

ICH E8(R1)ICH guideline on general considerations for clinical studies.
Supports quality by design and critical-to-quality thinking.Ch. 1, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

ICH E9ICH statistical principles for clinical trials.
Supports randomization, bias control, design, and analysis principles.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 18, Ch. 20, Ch. 22, Ch. 23, Ch. 25, Ch. 26, Ch. 30

ICH E9(R1)ICH addendum on estimands and sensitivity analysis.
Helps connect objectives, endpoints, intercurrent events, and interpretation.Ch. 1, Ch. 3, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 15, Ch. 17, Ch. 22, Ch. 23, Ch. 25, Ch. 26, Ch. 30

IDMCIndependent data monitoring committee.
Independent committee that may review accumulating data under a charter, sometimes including unblinded data.Ch. 8, Ch. 23, Ch. 26

IECIndependent ethics committee.
Reviews participant protection and ethical acceptability.Ch. 2, Ch. 12, Ch. 22, Ch. 23, Ch. 25, Ch. 26

II/IIIPhase II/III shorthand for a trial spanning learning and confirmatory objectives.
Use it when scope, governance, endpoints, safety monitoring, and decision gates must support both dose/learning and confirmatory evidence.Ch. 7, Ch. 8, Ch. 9, Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 6, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 21, Ch. 28

important protocol deviationAn important protocol deviation is one that may significantly affect participant safety, rights, or data reliability.
Use this term when reading or managing chapter situations where important protocol deviation affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 14, Ch. 20, Ch. 22

Inclusion criteriaCharacteristics required for participation.
Affects feasibility, safety, endpoint relevance, and recruitment.Ch. 3, Ch. 5, Ch. 10, Ch. 11

INDInvestigational new drug application.
U.S. regulatory pathway allowing investigational drug studies in humans.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 11, Ch. 12, Ch. 14, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 26

InspectionFormal review by a regulatory authority or inspector of trial conduct, records, systems, or sponsor/site/vendor oversight.
PM supports controlled request management, evidence mapping, and owner coordination.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Inspection findingObservation, deficiency, or concern identified during inspection or audit.
PM tracks response owners, evidence, due dates, CAPA links, and commitments.Ch. 21

Integrated project planCross-functional plan combining major deliverables, dependencies, milestones, and owners.
Helps clinical teams see how functions affect one another.Ch. 1, Ch. 10, Ch. 11, Ch. 17

Intercurrent eventEvent occurring after treatment initiation that affects interpretation or existence of endpoint measurements.
PM understands why missed treatment, discontinuation, rescue medication, death, or withdrawal may matter operationally and statistically.Ch. 10, Ch. 11, Ch. 17

Interim analysisPlanned analysis before the trial is complete.
Requires operational secrecy, data readiness, DMC/IDMC process, and decision rules.Ch. 1, Ch. 8

interventional studyAn interventional study is a study in which participants are assigned by the protocol to an intervention or comparison.
Use this term when reading or managing chapter situations where interventional study affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 2, Ch. 3, Ch. 5, Ch. 6, Ch. 9

investigational product (IP)The investigational product (IP) is the study treatment being tested or used as a comparator.
Use this term when reading or managing chapter situations where investigational product (ip) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12, Ch. 14

Investigator brochure / IBDocument summarizing clinical and nonclinical information about the investigational product.
Supports investigator understanding, safety review, and regulatory submissions.Ch. 12

investigator siteSite selection is the process of choosing investigator sites to participate in the trial.
Use this term when reading or managing chapter situations where investigator site affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

investigator site file (ISF)An investigator site file (ISF) is the site's version of essential trial records.
Use this term when reading or managing chapter situations where investigator site file (isf) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

IRBInstitutional review board.
Ethics review body protecting rights and welfare of human subjects.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 8, Ch. 12, Ch. 13, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26

IRB/IECInstitutional Review Board / Independent Ethics Committee shorthand.
Use it when tracking ethics submissions, approvals, consent changes, site activation, and amendment obligations.Ch. 2, Ch. 12, Ch. 13, Ch. 19, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 1, Ch. 3, Ch. 5, Ch. 8

IRTInteractive response technology used for randomization, treatment assignment, dispensing, resupply, and sometimes visit logistics.
PMs control IRT design, UAT, access, emergency unblinding, supply triggers, drug accountability, randomization reconciliation, and issue escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 26, Ch. 27, Ch. 29

ISFInvestigator site file.
Site-held file containing essential study documents.Ch. 12

IssueA current problem affecting the project.
Managed through an issue log with owner, impact, due date, action, and closure proof.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Issue logStructured tracker for current problems, owners, actions, dates, impact, and closure evidence.
Keeps execution blockers visible and prevents repeated re-discussion.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 12, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 23, Ch. 27, Ch. 29

ITTIntention-to-treat.
Analysis principle usually including participants as randomized.Ch. 17

KPIKey performance indicator.
Measures performance, such as enrollment, monitoring, query closure, or vendor delivery.Ch. 18

KPI/KRIKey performance indicator / key risk indicator shorthand.
Use it when distinguishing output performance from risk signals that may threaten participant protection or data reliability.Ch. 16, Ch. 18, Ch. 20

KRIKey risk indicator.
Warns of emerging risk, such as deviation trend, query aging, or data missingness.Ch. 18, Ch. 20

Last patient last visitLast patient last visit means the final participant completed the final protocol-defined visit or contact.
Use this term when reading or managing chapter situations where last patient last visit affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 14, Ch. 15, Ch. 16, Ch. 26

Lessons learnedEvidence-based conclusions about what should change in future work.
Converts trial experience into reusable organizational knowledge.Ch. 1, Ch. 18, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Local labA laboratory near or within a site used for clinical care or protocol-required tests, often with local reference ranges and local reporting workflows.
PMs watch local-lab variability, eligibility confirmation, safety decisions, source documentation, abnormal-result follow-up, and whether local results can affect blinding or endpoint consistency.Ch. 18

Lost to follow-upLost to follow-up means the team cannot contact the participant despite appropriate attempts.
Use this term when reading or managing chapter situations where lost to follow-up affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 26

LPILast patient in.
Milestone when the final participant enters the trial.Ch. 13, Ch. 25

LPLVLast patient last visit.
Milestone when the final participant completes the final protocol visit.Ch. 14, Ch. 15, Ch. 25

MADMultiple ascending dose.
Early-phase design involving repeated dosing at increasing dose levels.Ch. 6

MAPSMemory-aid style shorthand used in this handbook context.
Use it only as local book vocabulary and map the work back to canonical PM tools.Ch. 2, Ch. 3, Ch. 5, Ch. 15, Ch. 24, Ch. 28, Ch. 29, Ch. 30

maskingBlinding [ICH E9] or masking means keeping certain people unaware of treatment assignment to reduce bias.
Use this term when reading or managing chapter situations where masking affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 7, Ch. 9, Ch. 10

master protocolA master protocol is an overarching protocol structure that can evaluate multiple interventions, multiple populations, multiple diseases or disease subtypes, or some combination of those under one larger framework.
Use this term when reading or managing chapter situations where master protocol affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8

Medical monitorPhysician or medical expert overseeing clinical/safety aspects of the trial.
PM routes medical questions to the appropriate accountable medical owner.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 11, Ch. 14, Ch. 21, Ch. 23, Ch. 25, Ch. 26

MilestoneSignificant project event or completion point.
Examples include protocol finalization, first patient in, last patient last visit, database lock, and CSR finalization.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 9, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 23, Ch. 25, Ch. 27, Ch. 29

Missing dataExpected data that were not collected, entered, transferred, or usable.
PM tracks prevention, patterns, endpoint impact, and escalation rather than waiting for database lock.Ch. 1, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 15, Ch. 17, Ch. 19, Ch. 21, Ch. 22, Ch. 23, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 30

MonitoringMonitoring is sponsor oversight activity, often performed by clinical research associates, or CRAs, who review site conduct, source records, data, consent, investigational product accountability, and protocol compliance according to the monitoring plan.
Use this term when reading or managing chapter situations where monitoring affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 29, Ch. 30

Monitoring visitSite oversight visit, remote or onsite.
Produces monitoring reports, findings, follow-up letters, and issue signals.Ch. 2, Ch. 14, Ch. 19, Ch. 21

MultiplicityMultiple testing problem that can inflate false-positive risk.
PM should know when multiple endpoints, doses, looks, or subgroups require statistical control.Ch. 1, Ch. 3, Ch. 10, Ch. 17

NIHU.S. National Institutes of Health.
Use it when interpreting public clinical research terminology, trial education materials, or federally influenced expectations.Ch. 3, Ch. 7

Noninferiority marginPredefined maximum acceptable loss of effect versus comparator.
Operational deviations can threaten interpretability.Ch. 17

Noninferiority trialTrial designed to show a treatment is not unacceptably worse than a comparator by a predefined margin.
Requires careful design, adherence, data completeness, and interpretability.Ch. 1

Noninterventional studyStudy where investigators do not assign interventions by protocol.
Includes observational studies, registries, retrospective cohorts, and case-control designs.Ch. 5

ObjectiveStatement of what the study is intended to learn or demonstrate.
Keeps protocol, endpoint, vendor, data, and governance decisions aligned.Ch. 1, Ch. 3, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 26

ObjectivesThe study's primary, secondary, and exploratory aims.
Help the PM distinguish what is essential from what is supportive.Ch. 5, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 17, Ch. 29

Observational studyStudy where investigators observe outcomes without assigning intervention by protocol.
PM focuses on data source quality, definitions, bias, governance, and evidence limits.Ch. 3, Ch. 5

OHRPOffice for Human Research Protections.
U.S. office overseeing human-subject protection regulations for HHS-supported research.Ch. 2, Ch. 5, Ch. 19

Operational feasibilityOperational feasibility means whether patients, sites, vendors, systems, supply, budgets, timelines, and governance can execute the design with quality.
Use this term when reading or managing chapter situations where operational feasibility affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 11

Overclaim riskOverclaim risk is the risk that the team says more than the data can support.
Use this term when reading or managing chapter situations where overclaim risk affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 11

Parallel-group designTrial design where participants stay in assigned treatment groups for comparison.
Common operational model for randomized controlled trials.Ch. 1

Participant burdenParticipant burden means the time, travel, discomfort, risk, complexity, cost, emotional load, technology demand, or caregiver demand the study places on participants.
Use this term when reading or managing chapter situations where participant burden affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 2, Ch. 3, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 13, Ch. 14, Ch. 17, Ch. 19, Ch. 21, Ch. 22, Ch. 29, Ch. 30

patient populationThe patient population is the group the study intends to enroll.
Use this term when reading or managing chapter situations where patient population affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 10

PDPharmacodynamics.
Study of what the drug does to the body or biological target.Ch. 6

Phase IEarly human study often focused on safety, tolerability, dose, and PK/PD.
PM manages dose escalation, safety review, cohorts, and rapid decision cadence.Ch. 3, Ch. 6

Phase IIStudy often evaluating dose, preliminary efficacy, and continued safety.
PM balances learning objectives, endpoint feasibility, and operational realism.Ch. 1, Ch. 6, Ch. 9, Ch. 10

Phase IIILarger confirmatory study intended to support evidence of safety and efficacy.
PM manages scale, global execution, vendors, data quality, and governance pressure.Ch. 1, Ch. 2, Ch. 5, Ch. 6, Ch. 9, Ch. 21, Ch. 28

Phase IVPost-approval study.
PM may manage real-world, safety, comparative, or commitment-driven work.Ch. 6, Ch. 9

PIPrincipal investigator.
Common site-facing acronym for the investigator responsible for trial conduct at a site.Ch. 2, Ch. 12, Ch. 14, Ch. 21

PKPharmacokinetics.
Study of what the body does to a drug, including concentration over time.Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 18, Ch. 24, Ch. 27

PK/PDPharmacokinetic/pharmacodynamic relationship.
Supports dose, schedule, exposure-response, and study design decisions.Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 18, Ch. 24, Ch. 27

PlaceboInactive control designed to resemble active treatment.
Requires ethical, blinding, supply, and communication controls.Ch. 1, Ch. 3, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 17

PLANITProject-code or memory-aid style shorthand used in this handbook context.
Use it only as local book vocabulary and map the work back to canonical PM tools.Ch. 16

PMProject manager or project management, depending on context.
Integrates functions, vendors, sites, governance, risk, schedule, scope, and decision quality.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

PMBOKProject Management Body of Knowledge.
Used as a standard vocabulary source for project-management concepts adapted to clinical trials.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

PMIProject Management Institute.
Professional organization associated with PMBOK, PMP, and CAPM.Ch. 4, Ch. 16, Ch. 19, Ch. 27

PMPProject Management Professional.
PMI credential sometimes referenced for senior PM development.Ch. 27

populationThe population is the group the study is designed to learn about.
Use this term when reading or managing chapter situations where population affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 13, Ch. 15, Ch. 16, Ch. 17, Ch. 21, Ch. 23, Ch. 24, Ch. 25, Ch. 26

PowerProbability that a study will detect an effect of specified size under assumptions.
PM monitors whether enrollment, event rates, missingness, and protocol conduct threaten assumptions.Ch. 1, Ch. 4, Ch. 25, Ch. 26

pragmatic trialA pragmatic trial is designed to evaluate an intervention in conditions closer to routine care.
Use this term when reading or managing chapter situations where pragmatic trial affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8, Ch. 9

Pre-screeningPre-screening is an early check, often based on limited information, to see whether someone may be a possible fit before formal screening.
Use this term when reading or managing chapter situations where pre-screening affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 13

Primary endpointThe main endpoint used to answer the primary objective and usually the strongest determinant of trial success, interpretability, and regulatory or business decision-making.
PMs give the primary endpoint special operational protection: feasibility, site training, central reader/lab readiness, visit-window control, vendor oversight, query aging, missingness, protocol deviations, and SAP alignment all matter.Ch. 1, Ch. 2, Ch. 3, Ch. 6, Ch. 7, Ch. 10, Ch. 11, Ch. 14, Ch. 15, Ch. 17, Ch. 20, Ch. 21, Ch. 26

primary objectiveA primary objective is the main question.
Use this term when reading or managing chapter situations where primary objective affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10, Ch. 11

principal investigator (PI)A principal investigator (PI) is the qualified person responsible for trial conduct at that site.
Use this term when reading or managing chapter situations where principal investigator (pi) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

Problem-to-tool indexLookup approach matching common project problems to standard PM tools.
Helps readers choose the right tool instead of inventing a new table.Ch. 16

ProcurementFunction managing sourcing, purchasing, purchase orders, and vendor contracting process.
Supports vendor selection, contracting, PO control, and change-order routing.Ch. 2, Ch. 16, Ch. 18, Ch. 19, Ch. 26, Ch. 30

Product strategyProduct strategy is the business, medical, regulatory, and patient-access logic for developing a product.
Use this term when reading or managing chapter situations where product strategy affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10, Ch. 12

ProtocolThe controlled master document describing why the study is being done, who can participate, what will happen, when assessments occur, what endpoints matter, how safety is managed, and how data will support analysis.
PMs use the protocol as the operating contract across Medical, Statistics, Clinical Operations, Regulatory, Safety, Data, Quality, vendors, sites, and governance; feasibility problems often reveal themselves as protocol problems.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 29, Ch. 30

Protocol amendmentA formal approved change to the protocol that may alter objectives, design, population, assessments, endpoints, safety procedures, analysis, or operational requirements.
PMs coordinate amendment impact across regulatory/ethics submissions, ICF updates, site activation status, SIV/retraining, EDC/eCOA/IRT changes, vendor scope, budget, timeline, TMF, and communication control.Ch. 1, Ch. 3, Ch. 8, Ch. 11, Ch. 14, Ch. 21, Ch. 22, Ch. 23, Ch. 24

Protocol clarificationExplanation of existing protocol language without changing requirements.
Used carefully when an amendment is not required.Ch. 1, Ch. 3, Ch. 21

protocol conceptA protocol concept is earlier.
Use this term when reading or managing chapter situations where protocol concept affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 6, Ch. 10, Ch. 11, Ch. 12

Protocol deviationDeparture from the approved protocol.
PM tracks classification, impact, recurrence, corrective action, and escalation.Ch. 3, Ch. 6, Ch. 11, Ch. 14, Ch. 15, Ch. 16, Ch. 20, Ch. 22

Protocol driftGradual informal departure from protocol intent or procedure.
PM detects through repeated questions, deviations, workarounds, or inconsistent site behavior.Ch. 12, Ch. 13, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26

protocol review cycleA protocol review cycle is a structured round of review used to improve, reconcile, and approve protocol content.
Use this term when reading or managing chapter situations where protocol review cycle affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 11

Protocol synopsisConcise summary of key protocol elements.
Used during concept, governance, feasibility, and early planning.Ch. 10, Ch. 11

Protocol violationOlder or company-specific term sometimes used for serious protocol noncompliance.
Define locally; many organizations now prefer deviation categories rather than the term violation.Ch. 22

PVPharmacovigilance.
Drug safety surveillance and reporting function.Ch. 2, Ch. 3, Ch. 4, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

PV/CROPharmacovigilance / contract research organization interface shorthand.
Use it when safety reporting work is delegated but sponsor oversight, reconciliation, escalation, and evidence remain accountable.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Q3Third calendar quarter or third fiscal quarter, depending on sponsor context.
Use it when executive timing language must be translated into actual milestones, dependencies, and decision dates.Ch. 1, Ch. 10

QAQuality assurance.
Function focused on quality systems, audits, compliance, and inspection readiness.Ch. 20

QCQuality control.
Checking work products or processes against defined standards.Ch. 2, Ch. 15, Ch. 16, Ch. 19, Ch. 20, Ch. 21, Ch. 24

QTLQuality tolerance limit: a predefined trial-level threshold for important quality variation that triggers evaluation when approached or exceeded.
PMs track QTL status, evidence, owner, root-cause review, corrective action, governance communication, and documentation of evaluation.Ch. 20

QTL/KRIQuality tolerance limit / key risk indicator shorthand.
Use it when monitoring whether quality or risk signals exceed predefined thresholds.Ch. 20, Ch. 21, Ch. 23, Ch. 18

Quality by designQuality by design means building quality into the study by identifying and protecting those factors from the start.
Use this term when reading or managing chapter situations where quality by design affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 29, Ch. 30

QueryData question or request for clarification/correction.
PM monitors aging, criticality, site burden, and database-lock impact.Ch. 1, Ch. 2, Ch. 3, Ch. 6, Ch. 7, Ch. 10, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 19, Ch. 21, Ch. 22, Ch. 24, Ch. 26, Ch. 27, Ch. 28, Ch. 29

RACIResponsible, Accountable, Consulted, Informed.
Clarifies who does the work, who owns the outcome, who advises, and who must be informed.Ch. 2, Ch. 3, Ch. 6, Ch. 7, Ch. 12, Ch. 14, Ch. 16, Ch. 17, Ch. 23, Ch. 25, Ch. 27, Ch. 29

RAID logRisks, Assumptions, Issues, and Dependencies log.
Core PM tool for managing uncertainty across trial workstreams.Ch. 1, Ch. 4, Ch. 15, Ch. 16, Ch. 21, Ch. 22, Ch. 29

RandomizationAssignment of participants to treatment groups by chance according to a prespecified method, often implemented through IRT/RTSM and protected by allocation concealment.
PMs ensure randomization logic, strata, supply, site training, emergency unblinding, data transfers, and reconciliation are operationally controlled; failures can threaten comparability and credibility.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 27, Ch. 29, Ch. 30

RandomizedRandomized [ICH E9] means assigned by chance to a study arm.
Use this term when reading or managing chapter situations where randomized affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 13, Ch. 14, Ch. 17, Ch. 18, Ch. 20

Randomized controlled trial / RCTTrial assigning participants by chance to intervention or control.
Common confirmatory design requiring strong operational controls.Ch. 17

RBMRisk-based monitoring.
Monitoring approach focusing resources on important risks.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 11, Ch. 12, Ch. 14, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 29, Ch. 30

RBQMRisk-based quality management: a proactive approach that identifies what is critical to participant protection and data reliability, then manages important risks proportionately.
PMs use RBQM to focus attention on CTQs, QTLs, KRIs, monitoring strategy, vendor oversight, issue trends, and governed action rather than equal effort everywhere.Ch. 6, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23

RebaselineFormal reset of approved schedule, budget, scope, or assumptions.
Used when the old baseline no longer represents a credible plan.Ch. 18, Ch. 19, Ch. 20, Ch. 22, Ch. 23, Ch. 24

ReconciliationReconciliation means checking that data from different sources match or that differences are explained.
Use this term when reading or managing chapter situations where reconciliation affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 3, Ch. 4, Ch. 7, Ch. 11, Ch. 12, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

RecruitmentActivities used to identify and attract potential participants.
Must respect approved materials, fairness, feasibility, diversity, and participant burden.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 16, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 25, Ch. 27, Ch. 30

registryA registry is an organized system that collects uniform data for a population defined by a disease, condition, exposure, product, procedure, or other shared characteristic.
Use this term when reading or managing chapter situations where registry affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 5, Ch. 6, Ch. 9, Ch. 12, Ch. 13, Ch. 16, Ch. 19, Ch. 26

Rejected recordData record that fails transfer or acceptance checks.
Important vendor/data quality signal.Ch. 15

ReportabilityDetermination of whether a safety event or issue must be reported to regulators, IRBs/IECs, investigators, or other parties.
PM tracks timelines, owners, and evidence while Safety/Regulatory determine requirements.Ch. 3, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 23

Rescue medicationRescue medication is treatment allowed to protect participants if their condition worsens or if withholding treatment would be unsafe or unethical.
Use this term when reading or managing chapter situations where rescue medication affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 17, Ch. 22, Ch. 23

Rescue planStructured intervention to recover or responsibly redirect a troubled trial.
Requires root-cause diagnosis, governance, owners, metrics, and tradeoff decisions.Ch. 19, Ch. 21

Response-adaptive randomizationResponse-adaptive randomization means future assignments may be shifted based on accumulating response data under a planned algorithm.
Use this term when reading or managing chapter situations where response-adaptive randomization affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8

RetentionKeeping participants engaged through follow-up.
Protects data completeness, safety follow-up, and endpoint credibility.Ch. 1, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 26, Ch. 27, Ch. 30

RFPRequest for proposal.
Used when selecting CROs or vendors for trial services.Ch. 2, Ch. 18, Ch. 30

RiskAn uncertain future event that could affect objectives.
Managed before it becomes an issue.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Risk acceptanceFormal decision to proceed while knowingly carrying residual risk.
Requires appropriate authority when participant, data, regulatory, budget, or timeline risk remains.Ch. 2, Ch. 4, Ch. 11, Ch. 12, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 28, Ch. 29, Ch. 30

Risk registerStructured tracker for risks, triggers, owners, mitigations, contingencies, and status.
Central PM tool for proactive trial control.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 25, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Risk-based monitoringRisk-based monitoring [FDA RBM 2023] means focusing oversight proportionately on risks that matter most to participant protection and data reliability.
Use this term when reading or managing chapter situations where risk-based monitoring affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 11, Ch. 12, Ch. 14, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 29, Ch. 30

Root causeUnderlying reason a problem occurred.
Prevents weak fixes that address symptoms but leave the process failure intact.Ch. 1, Ch. 2, Ch. 3, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 28, Ch. 29, Ch. 30

Root-cause analysisStructured investigation of why an issue, deviation, finding, or failure occurred.
Used before CAPA, rescue planning, vendor remediation, or governance escalation.Ch. 2, Ch. 21

Root-cause reviewStructured investigation of why a problem occurred.
Prevents superficial fixes such as repeated retraining without process correction.Ch. 1, Ch. 22, Ch. 23

RTSMRandomization and trial supply management.
Technology/process area related to randomization and drug supply.Ch. 8

RWDReal-world data such as EHR, claims, registry, device, app, or routine-care data.
Use it when assessing source reliability, data provenance, privacy, linkage, missingness, and analytic fitness.Ch. 5

RWD/RWECombined shorthand for real-world data and real-world evidence.
Use it when the PM must separate data-source readiness from the evidence claim the study can support.Ch. 5, Ch. 9

RWEReal-world evidence generated from data relating to routine care or nontraditional evidence sources.
Use it when a project depends on registry, claims, EHR, observational, or pragmatic evidence rather than only conventional interventional trial data.Ch. 5, Ch. 9

SADSingle ascending dose.
Early-phase design involving one-time dosing across escalating dose levels.Ch. 6

safety signalA safety signal is information that suggests a possible new or changed safety risk and needs further evaluation.
Use this term when reading or managing chapter situations where safety signal affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 23, Ch. 24, Ch. 25, Ch. 29, Ch. 30

Sample-size re-estimationSample-size re-estimation means reassessing the needed number of participants under prespecified rules.
Use this term when reading or managing chapter situations where sample-size re-estimation affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8

SAPStatistical analysis plan: controlled document describing statistical methods, analysis populations, endpoints, handling of missing data, sensitivity analyses, and outputs.
PMs align data-cleaning, protocol deviation review, database lock, TLF production, CSR timing, and governance expectations with the SAP.Ch. 2, Ch. 3, Ch. 15, Ch. 16, Ch. 17, Ch. 22, Ch. 25, Ch. 28, Ch. 29

SAP/TLFStatistical analysis plan / tables, listings, and figures shorthand.
Use it when endpoint conduct, missing data, database lock, and programming readiness affect statistical output.Ch. 28, Ch. 29, Ch. 2, Ch. 3, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 22, Ch. 25

Scenario planningThe PM should make scenario planning normal.
Use this term when reading or managing chapter situations where scenario planning affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 9, Ch. 10, Ch. 16

Scenario questionPractice question based on realistic operational situations.
Helps readers apply PM tools and clinical judgment.Ch. 29

schedule of assessments (SOA)The schedule of assessments (SOA) is the table that shows what happens at each study visit: procedures, labs, questionnaires, dosing, safety checks, imaging, samples, calls, and follow-up activities.
Use this term when reading or managing chapter situations where schedule of assessments (soa) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 11, Ch. 12

Schedule varianceDifference between planned and actual or forecast timing.
Helps diagnose whether a delay is caused by startup, enrollment, vendor, data, regulatory, or decision issues.Ch. 16

ScopeWork included in the project or vendor agreement.
Defines what the study team, CRO, vendor, or function is expected to deliver.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 21, Ch. 22, Ch. 24, Ch. 25, Ch. 27, Ch. 28

Screen failureA consented person who is evaluated but does not qualify for enrollment/randomization.
Important feasibility signal that may reveal protocol or site-process problems.Ch. 1, Ch. 3, Ch. 11, Ch. 13, Ch. 19, Ch. 21

ScreeningAssessing potential participants against eligibility criteria.
PM monitors burden, timing, failures, and site workflow.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 8, Ch. 11, Ch. 12, Ch. 13, Ch. 21, Ch. 26, Ch. 29

SDRSource data review.
Review of source data and site processes to assess quality and reliability.Ch. 3

SDTMStudy Data Tabulation Model.
CDISC standard for tabulation datasets.Ch. 15, Ch. 17

SDVSource data verification.
Checking entered trial data against source records.Ch. 3

Secondary endpointA prespecified endpoint supporting secondary objectives, often used to understand additional benefits, risks, mechanisms, or clinically important effects beyond the primary endpoint.
PMs manage secondary endpoints with enough discipline to support credible labeling, publication, reimbursement, or development decisions, while keeping priority clear when resources or timelines are strained.Ch. 6, Ch. 10, Ch. 17

SeriousnessRegulatory safety concept describing whether an AE meets serious criteria.
Determined by qualified safety/medical owners, not independently by the PM.Ch. 1, Ch. 3, Ch. 4, Ch. 5, Ch. 7, Ch. 10, Ch. 11, Ch. 14, Ch. 16, Ch. 18, Ch. 23, Ch. 28

SIISite initiation instruction or site initiation information, depending on company usage.
Not a universal industry acronym; if used, define locally and distinguish from SIV.Ch. 12

siteA site is not just a location.
Use this term when reading or managing chapter situations where site affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Site activationCompletion of required steps before a site can begin screening or enrollment.
Startup metric that must be separated from true enrollment performance.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 16, Ch. 19, Ch. 21, Ch. 22, Ch. 27, Ch. 28

Site burdenSite burden means the workload, staffing, training, documentation, equipment, scheduling, and coordination the study places on sites.
Use this term when reading or managing chapter situations where site burden affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 4, Ch. 5, Ch. 6, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 13, Ch. 21, Ch. 22, Ch. 25, Ch. 29, Ch. 30

Site closeoutProcess of ending site trial activity and ensuring records, data, drug, and actions are complete.
Key closing activity.Ch. 24, Ch. 26, Ch. 27

site initiation visit (SIV)A site initiation visit (SIV) is a meeting or process used to train and prepare site staff before activation.
Use this term when reading or managing chapter situations where site initiation visit (siv) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12

Site selectionSite selection is the process of choosing investigator sites to participate in the trial.
Use this term when reading or managing chapter situations where site selection affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12, Ch. 27

SIVSite initiation visit: the formal startup meeting or visit confirming a site is trained and operationally ready to conduct the study.
PMs make sure SIV content covers protocol conduct, endpoint-critical procedures, safety reporting, consent, IP, IRT/EDC/eCOA, central/local labs, vendor handoffs, documentation, and escalation pathways.Ch. 12

SLAService-level agreement.
Defines expected vendor service standards such as turnaround time or response time.Ch. 18

SLA/KPIService-level agreement / key performance indicator shorthand.
Use it when vendor expectations, timeliness, quality evidence, and escalation thresholds must be measurable.Ch. 18

SMARTSequential multiple assignment randomized trial.
Use it when adaptive treatment strategies, re-randomization, or dynamic treatment pathways create operational and statistical dependencies.Ch. 8, Ch. 24

SMESubject matter expert.
Functional expert consulted for medical, safety, statistics, data, regulatory, quality, technology, or vendor questions.Ch. 24

SOASchedule of assessments.
Protocol table listing study visits, procedures, and timing.Ch. 11, Ch. 12

SOCRASociety of Clinical Research Associates.
Use it as a professional-development and clinical research operations reference context.Ch. 27

SOPStandard operating procedure.
Use it when the PM needs to know whether repeated work follows an approved process and whether deviations require documentation or correction.Ch. 4, Ch. 29

Source dataOriginal data or certified copies where trial information is first recorded.
PM makes sure monitoring, data review, and inspection packages can trace key data back to source.Ch. 3, Ch. 11, Ch. 14, Ch. 15, Ch. 23, Ch. 27

Source documentOriginal record where trial data first appear.
Supports monitoring, SDV/SDR, data integrity, and inspection readiness.Ch. 3

source documentsFor a new reader, source documents are the original records or certified copies that support trial data.
Use this term when reading or managing chapter situations where source documents affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 18

SOWStatement of work.
Contract document defining vendor/CRO scope, deliverables, responsibilities, assumptions, and pricing logic.Ch. 16, Ch. 18, Ch. 19, Ch. 22

SPIRITStandard Protocol Items: Recommendations for Interventional Trials.
Use it as a protocol-quality reference point when checking whether trial planning information is complete and understandable.Ch. 1, Ch. 11

SSISite selection information, site startup information, or site-specific instruction, depending on company usage.
Not a universal industry acronym; if used, define locally to avoid confusion.Ch. 12

Stakeholder mapTool identifying stakeholders, interests, influence, communication needs, and escalation pathways.
Helps the PM manage sponsors, CROs, sites, vendors, functions, and leadership.Ch. 1, Ch. 2, Ch. 3, Ch. 5, Ch. 10, Ch. 13, Ch. 18, Ch. 25, Ch. 29

Standard of careStandard of care means usual accepted care in a setting, though what counts as usual may vary by region and disease context.
Use this term when reading or managing chapter situations where standard of care affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13

StartupActivities needed before active study conduct at sites.
Includes country setup, contracts, budgets, regulatory/ethics approvals, vendor/system readiness, and SIV.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 30

stopping ruleA stopping rule is a prespecified rule for pausing or stopping a trial, arm, dose, or enrollment path when defined conditions are met.
Use this term when reading or managing chapter situations where stopping rule affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8

StratificationRandomization or analysis method grouping participants by important factors.
Requires correct data capture and IRT setup.Ch. 7

study armThe study arm is a group in the trial, such as investigational vaccine, placebo, active comparator, standard-of-care comparison, or no intervention depending on the design.
Use this term when reading or managing chapter situations where study arm affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 7, Ch. 13

Study closeoutCompletion of trial operations, data, safety, documentation, vendors, sites, finance, and reporting obligations.
Ensures the trial ends responsibly and remains defensible.Ch. 15, Ch. 19, Ch. 24, Ch. 25

Study startupStudy startup is the coordinated work that prepares a clinical trial to begin at countries and sites.
Use this term when reading or managing chapter situations where study startup affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 12, Ch. 23, Ch. 24, Ch. 27

SubgroupDefined subset of participants.
PM should watch whether subgroup promises affect enrollment, power, or interpretation.Ch. 6, Ch. 8, Ch. 9, Ch. 11, Ch. 17

substudyA substudy is a study component within the master protocol.
Use this term when reading or managing chapter situations where substudy affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8, Ch. 11

Superiority trialTrial designed to show one treatment is better than another or control.
Requires endpoint, sample size, adherence, and data quality discipline.Ch. 7

SUSARSuspected unexpected serious adverse reaction.
Expedited safety reporting concept in many regulatory frameworks.Ch. 3, Ch. 23

suspected adverse reactionA suspected adverse reaction is an adverse event for which there is a reasonable possibility that the drug or biologic caused the event, in the IND safety-reporting context.
Use this term when reading or managing chapter situations where suspected adverse reaction affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 14

SynopsisSee protocol synopsis.
Helps leaders evaluate concept and design before the full protocol is built.Ch. 9, Ch. 10, Ch. 11, Ch. 22

target product profile (TPP)A target product profile (TPP) is a strategic development tool that describes the intended future profile of a product, often in language that resembles possible labeling concepts.
Use this term when reading or managing chapter situations where target product profile (tpp) affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 10

televisitA televisit is a remote trial visit, often by video or phone.
Use this term when reading or managing chapter situations where televisit affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 8

temperature excursionFor a beginner, a temperature excursion means the investigational product or comparator was exposed to temperatures outside the defined acceptable range.
Use this term when reading or managing chapter situations where temperature excursion affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 4, Ch. 7, Ch. 12, Ch. 14

TLFTables, listings, and figures.
Statistical outputs used for analysis, review, CSR, and submission.Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19

TMF / trial master fileThe sponsor's essential-document collection showing how the trial was planned, approved, conducted, supervised, changed, and closed.
PMs treat the TMF as trial memory: records must be complete, current, attributable, version-controlled, retrievable, and able to support audit or inspection reconstruction.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 6, Ch. 8, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 15, Ch. 16, Ch. 18, Ch. 20, Ch. 21, Ch. 22, Ch. 24, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Tool shellReusable template or structure for applying a PM tool.
Supports standardization across chapters and project stages.Ch. 16

trade-offA trade-off is a choice where improving one value may weaken another.
Use this term when reading or managing chapter situations where trade-off affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 9

treatment armA treatment arm is a group assigned to receive a specific intervention or comparator.
Use this term when reading or managing chapter situations where treatment arm affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 3, Ch. 10, Ch. 13, Ch. 15

Treatment periodPortion of a trial when participants receive assigned intervention.
Requires dosing, monitoring, safety, visit, and data controls.Ch. 2, Ch. 3, Ch. 14

trial designA trial design is the planned structure for answering a clinical question.
Use this term when reading or managing chapter situations where trial design affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 1, Ch. 5, Ch. 8, Ch. 9, Ch. 13, Ch. 21, Ch. 25, Ch. 26

UAT / user acceptance testingTesting by intended users or qualified representatives to confirm that a configured system supports required clinical trial workflows before release.
PMs track UAT scripts, defects, retesting, sign-off, access, training, audit trail expectations, and release decisions for EDC, eCOA, IRT/RTSM, portals, data transfers, and reporting systems.Ch. 6, Ch. 7, Ch. 11, Ch. 12

UnblindingPlanned or accidental disclosure of treatment assignment or other protected information before the intended time.
PMs escalate potential unblinding immediately, preserve the evidence trail, route safety or emergency decisions to qualified owners, assess affected roles/data, and protect remaining trial integrity.Ch. 3, Ch. 4, Ch. 6, Ch. 7, Ch. 8, Ch. 15, Ch. 17, Ch. 20, Ch. 23

ValidationDocumented evidence that a system or process works as intended.
Critical for clinical systems, vendor tools, and data workflows.Ch. 1, Ch. 2, Ch. 5, Ch. 8, Ch. 15, Ch. 18, Ch. 21, Ch. 24, Ch. 30

VendorExternal provider performing contracted trial work, such as central lab, imaging, eCOA, IRT/RTSM, clinical supply, translations, call center, home health, bioanalytical, data, or medical writing services.
PMs oversee vendor readiness, interfaces, SLAs, data transfers, quality events, change orders, budget impact, inspection evidence, and issue closure.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 12, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 28, Ch. 29, Ch. 30

Visit windowAllowed timing range around a scheduled visit or assessment, usually defined in the protocol or study manual.
PMs monitor window compliance because missed windows can become deviations, missing data, endpoint bias, safety follow-up gaps, or analysis complications.Ch. 2, Ch. 3, Ch. 5, Ch. 7, Ch. 11, Ch. 13, Ch. 14, Ch. 22

WashoutPeriod allowing prior treatment to clear before another treatment or period begins.
Critical in crossover and BA/BE designs.Ch. 6, Ch. 7, Ch. 9, Ch. 11, Ch. 17, Ch. 22, Ch. 24

WBSWork breakdown structure.
Decomposes a clinical trial into manageable work packages such as protocol, startup, enrollment, treatment, data, safety, vendors, and closeout.Ch. 8, Ch. 10, Ch. 11, Ch. 12, Ch. 16, Ch. 17

wearableA wearable is a device worn by a participant that can collect trial-related data.
Use this term when reading or managing chapter situations where wearable affects scope, participant protection, evidence quality, owners, timing, or escalation.Ch. 7, Ch. 8

WHOWorld Health Organization.
Global health body; may be relevant to registries, standards, and public-health context.Ch. 1, Ch. 2, Ch. 3, Ch. 4, Ch. 5, Ch. 6, Ch. 7, Ch. 8, Ch. 9, Ch. 10, Ch. 11, Ch. 13, Ch. 14, Ch. 15, Ch. 16, Ch. 17, Ch. 18, Ch. 19, Ch. 20, Ch. 21, Ch. 22, Ch. 23, Ch. 24, Ch. 25, Ch. 26, Ch. 27, Ch. 29, Ch. 30

WorkstreamA related set of project activities owned by a function or team.
Examples include startup, clinical operations, data management, safety, regulatory, vendor management, supply, and TMF.Ch. 5, Ch. 9, Ch. 16