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E6(R3) Site Kit 05 — Recruitment, Consent & Protocol Compliance
$369.00
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Finding participants, consenting them properly, and dealing with it when the protocol is not followed.
3 procedures, 16 records. Answers 33 site-facing E6(R3) expectations — 9 new in R3 and 10 scored critical, the highest critical count in the suite.
- Participant recruitment, screening and eligibility determination
- Informed consent, including electronic and remote consent
- Protocol compliance and management of protocol deviations
If you take one paid kit, this is the one an inspector is most likely to open first.
Word and Excel, editable, no macros. Individual Licence. These are templates, not an approved quality system.