Anavex Life Sciences Corp (AVXL)

[nidan7500]

Rubyred--Thx

Although the IRB must follow written procedures for functions and operations specifically described at 45 CFR 46.103(b)(4) and (5), and/or 21 CFR 56.108(a) and (b), there are other IRB activities that require findings and determinations for which the underlying regulations do not explicitly require the IRB to follow a written procedure. The Checklist includes footnotes that identify these underlying regulations, as well as other relevant regulations that we recommend institutions and IRBs consider when preparing written procedures.

For example, an IRB that reviews studies involving children must follow the regulatory requirements for additional safeguards for children at 45 CFR part 46, subpart D, and/or 21 CFR part 50, subpart D, and approve only those studies that satisfy the conditions of all applicable sections of those subparts. Although the subpart D regulations do not explicitly require an IRB to follow a written procedure for review of studies involving children, OHRP and FDA recommend that written procedures for the IRB address the review of such studies (see recommendation #10 in the Checklist under the regulatory requirement regarding written procedures for conducting initial and continuing review).

(Note MUST=SHALL)

https://www.outsourcing-pharma.com/Article/2018/05/17/FDA-issues-final-guidance-in-effort-to-protect-clinical-trial-participants