Toolkits › E6(R3) Annex 1 — Sponsor Responsibilities
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E6(R3) Annex 1 — Sponsor Responsibilities
Eleven kits covering all affected sponsor procedures and every form, log and register they reference. Grouped by the job, not by the guideline’s numbering.
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Two ways to find out what you need.
E6(R3) Executive Briefing
What changed and what it means for a sponsor, in a deck you can put in front of a steering committee.
Sponsor Gap Assessment
157 expectations scored against your current state. Names the kit that closes each gap, so you buy what you are missing and nothing else.
TAKE WHAT YOU NEED
Activity kits.
Have a specific gap? Buy the kits à la carte. Each one holds the procedures for a single activity, plus every form, log and template those procedures reference. You pay per procedure — the supporting documents come with it. Every kit also ships with a Read Me First, the suite-wide Transfer Oversight Matrix, the E6(R3) Change Matrix and worked examples of the trickier logs.
Quality System Foundations
Procedures includedDocument control · Risk-based quality management · Qualification & training
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Oversight, Audit & CAPA
Procedures includedSponsor oversight & allocation · Quality assurance & audit · Deviations, noncompliance & CAPA
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Vendor Selection & Oversight
Procedures includedVendor agreements & transfers · Provider selection & evaluation · Business continuity
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Trial Design & Protocol
Procedures includedProtocol · Protocol amendments
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Study Start-Up
Procedures includedFeasibility & site selection · Regulatory & IRB/IEC communication · Agreements, financing & payments · Insurance & indemnity
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Investigational Product & Blinding
Procedures includedInvestigational product supply · Randomisation & blinding
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Safety & Medical Oversight
Procedures includedInvestigator’s Brochure & RSI · Safety reporting & immediate hazards · Medical monitoring & committees
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Monitoring
Procedures includedMonitoring
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Data Governance & Systems
Procedures includedData governance & management · Computerised systems & access
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Records, TMF & Inspection Readiness
Procedures includedTMF, essential records & retention · Inspection readiness
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Close-Out & Disclosure
Procedures includedRegistration & disclosure · Close-out & termination
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.Some expectations name more than one procedure, so the per-kit counts add up to more than the eleven kits answer between them. Each expectation is counted under every kit that answers it; the complete set counts it once.
Or take the complete Sponsor set
All eleven kits, covering 157 E6(R3) Annex 1 expectations, including every one of the 32 new requirements. A Read Me First in each kit lays out best practices for deploying them against an existing QMS.
27 procedures, 122 unique templates and 28 worked examples. Unique is the operative word — several documents earn their place in more than one kit, and the complete set counts them once rather than selling you the same form twice.
Individual licence
Every study your own organisation runs. No seat counting, no renewal.
Practice licence
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.
Deploy across more than one client organisation.
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Practice licence. For CROs, consultants and site networks who deploy these documents across more than one client organisation. An individual licence covers only your own organisation’s studies. Available on complete sets, not on single kits.OTHER TOPICS
Looking at this from the site side?
IF YOU WOULD RATHER NOT DIY
The files, or someone accountable for them landing.
A kit gives you the documents. An engagement gives you an operator who owns the outcome.