Toolkits › E6(R3) Annex 1 — Site Responsibilities
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E6(R3) Annex 1 — Site Responsibilities
11 kits. 24 procedures and the 101 forms, logs and registers they reference. Written from a site perspective, and designed so you never start from a blank page.
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Know the size of the job first.
Free gap assessment
134 site-facing E6(R3) expectations, scored against what your site does now. By our count, 65% are new or expanded since E6(R2).
TAKE WHAT YOU NEED
Site kits.
Have a specific gap? Buy the kits à la carte. Each one holds the procedures, forms, logs and registers that answer the Annex 1 expectations for that topic. Built for ease-of-use: drop-down fields where the answer is a choice, ghost text where it isn't, and worked examples of the registers that catch people out. Every kit also carries its own Instructions for Use and the three suite tools — the Site SOP Adoption Register, the E6(R2)-to-E6(R3) Change Matrix and the Recurring Obligation Tracker.
Quality System Foundations
Procedures includedDocument control · Quality by design and risk · Training and qualification records
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Investigator Oversight and Delegation
Procedures includedDelegation and oversight · Conflict of interest
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Service Provider Oversight
Procedures includedService providers
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Start-Up and Committee Communication
Procedures includedFeasibility and acceptance · Committee and sponsor communication
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Recruitment, Consent and Protocol Compliance
Procedures includedRecruitment and eligibility · Informed consent · Protocol deviations
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Investigational Product and Blinding
Procedures includedRandomisation and blinding · Investigational product
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Safety and Medical Oversight
Procedures includedSafety reporting
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Samples and Local Laboratory
Procedures includedSample handling Equipment calibration
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Data, Source Records and Systems
Procedures includedSource records and data · Computerised systems · Decentralised trials
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Records, ISF and Inspection Readiness
Procedures includedEssential records · Inspection readiness
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Payments, Close-out and Continuity
Procedures includedParticipant payments · Site close-out · Business continuity
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.Several forms earn their place in more than one kit, and some expectations name more than one procedure — so the card counts add up to more than the eleven kits answer between them. Shared items are counted under each document that answers them, and the complete core counts each one once.
Or take the complete site core
All eleven kits — the twenty-four procedures an investigator site needs, answering 132 of the 134 site-facing expectations in the E6(R3) Principles and Annex 1, including 48 of the 50 that are new in R3. The other two apply only to some sites — sponsor-investigator duties and trial registration — and specialist modules for them are on the way.
The core is one system rather than eleven separate things: every procedure hands work to, or takes work from, others by name. 101 unique records — several earn their place in more than one kit, and the complete core counts them once rather than selling you the same form twice.
Individual licence
Every trial your own site or institution runs. No seat counting, no renewal.
Multi-site licence
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.
Deploy across more than one site.
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Multi-site licence. For site networks, SMOs and institutions deploying these documents across more than one site. An individual licence covers only your own. Available on the complete core, not on single kits.OTHER TOPICS
Looking at this from the sponsor side?
IF YOU WOULD RATHER NOT DIY
The files, or someone who has sat in your chair.
A kit gives you the documents. An engagement gives you someone who has built a site quality system before and will own this one landing.