VA HEALTH CARE PRINCIPAL INVESTIGATOR GUIDE has been updated to comply changes required as part of the University of Iowa Human Research Protection Program Reaccreditation review. A track change version is also available.
A summary of those changes is also contained below:
Updated Content |
Section\Page |
Updated phone numbers to include a “63” in front of all VA Extensions. |
Throughout VA Guide |
Adding disclosure statements to consent based on ICH-GCP (E6) (R2) guidelines |
5.B ICH-GCP/p. 24-25, Section 5.B.i What does this mean? (pg. 122) |
Removing expectation to request a waiver of informed consent or waiver of documentation of consent for screening purposes |
5.E.ii Screening, recruiting, or determining eligibility prior to a signed informed consent document/p. 30 |
Adding section on ICH-GCP (E6) (R2) guidelines for non-therapeutic clinical trials |
7.M.IX Non Therapeutic Clinical Trials following full ICH-GCP (E6)(R2) New section/p. 48 |
Research falling under the FDA using REDCAP are subject to ensuring 21 CFR 11 requirements are met. |
12.B.i Distribution/storage by use of Redcap (pg. 112) |
Clarification added to expectations of record retention Specific documents required now identified |
9.D.iv.b.ii Recordkeeping and record retention 21 CFR 312.57/p. 72 |