Protocol synopsis and expanded synopsis review
Concept review, governance authorization, protocol drafting, startup handoff.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Templates
Reusable operating assets, not one-off tables.
Open the template when the story feels familiar: startup is slipping, a vendor signal is vague, an endpoint is at risk, or governance needs evidence instead of reassurance.
Startup
Startup templates and plays
Integrated study startup plan
Before site activation and first participant in.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Startup tracker
Study startup.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Functional readiness matrix
Study initiation, startup, country launch, rescue restart.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Risk / Issue
Risk / Issue templates and plays
Risk register
Planning and monitoring.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Issue log
Any realized blocker.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Action tracker
Every operating cadence.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Decision log
Governance meetings, amendments, rescue choices.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Root-cause analysis
A deviation trend, vendor failure, data-quality signal, safety-process concern, recruitment miss, inspection observation, or repeated site issue cannot be solved by assigning another action item.
Owner model: Quality or the accountable process owner leads the RCA method; the PM coordinates evidence, owners, timing, decision forums, and follow-through.CAPA tracker
Audit findings, recurring issues, inspection observations.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Vendor
Vendor templates and plays
RACI / responsibility assignment matrix
Role confusion, sponsor/CRO/vendor boundaries.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.SOW/deliverables tracker
Vendor oversight.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.SLA/KPI/KRI tracker
Ongoing oversight.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Communication plan
All trials.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Data Lock
Data Lock templates and plays
eCRF/EDC requirements and build readiness checklist
EDC build, protocol amendment, database-lock preparation.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.SAP and TLF dependency plan
Before database lock, CSR planning, interim analysis planning.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Database-lock readiness plan
Data cleaning and analysis phase.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Governance
Governance templates and plays
Project charter
Concept approval, protocol strategy, rescue restart, major phase transition.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Stakeholder register
Any new trial, vendor transition, inspection, country expansion.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Change request form
Protocol, scope, vendor, schedule, budget, system, monitoring changes.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Change impact assessment
Amendments, rescue, rebaseline.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Inspection
Inspection templates and plays
Inspection request/response tracker
Inspection preparation and conduct.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.CAPA tracker
Audit findings, recurring issues, inspection observations.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Decision log
Governance meetings, amendments, rescue choices.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.Communication plan
All trials.
Owner model: PM integrates the artifact; the accountable functional lead owns technical content where applicable.