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Answers from people who do the work, with the official source attached.
- Where is Part 11 when QA asks whether our e-signatures are compliant?
21 CFR Part 11 is the US regulation on electronic records and electronic signatures. The eCFR holds the current text in three subparts: General Provisions, Electronic Records and Electronic Signatures.
Data and systemswww.ecfr.gov - Which Declaration of Helsinki is current for a 2026 protocol?
The current version was adopted by the 75th WMA General Assembly in Helsinki, Finland, in October 2024. The World Medical Association publishes the full text, titled Ethical Principles for Medical Research Involving Human Participants. Earlier versions are archived and superseded.
Regulations and guidancewww.wma.net - Who goes on the 1572 and who does not? Where are FDA's answers?
FDA has an information sheet, Frequently Asked Questions: Statement of Investigator (Form FDA 1572), final and dated June 2010. It answers common questions from sponsors, clinical investigators and IRBs about completing the form for studies of investigational drugs and biologics under the IND regulations.
Site operationswww.fda.gov - Someone said 'E3'. What is that, and is it the GCP guideline?
ICH E3 is the guideline on the structure and content of clinical study reports. It sets out one core report format that all ICH regions can accept, with regional requirements handled in appendices. FDA published it as a final guidance in July 1996. It is not the GCP guideline, which is ICH E6.
Regulations and guidancewww.fda.gov - When does E6(R3) apply at EU sites, and what is Annex 2?
On the EMA page, the ICH E6(R3) Principles and Annex 1 are effective from 23 July 2025. Annex 2 reached Step 4 with ICH adoption on 3 June 2026 and CHMP adoption on 25 June 2026, and comes into effect on 15 January 2027.
Regulations and guidancewww.ema.europa.eu - Which GCP version should my training certificate say, and where is it?
The current Good Clinical Practice guideline is ICH E6(R3). FDA published it as a final guidance in September 2025 (docket FDA-2023-D-1955). The FDA page below holds the document. ICH E3 is a different guideline, about clinical study reports.
Regulations and guidancewww.fda.gov