- New FAQ Posted: The Frequently Asked Questions (FAQs) page has been updated with one new FAQ:
For an applicable clinical trial (ACT) for which results information must be submitted under 42 CFR 11.42, if a certification of delay for an unapproved product (“certify initial approval”) has been submitted under 42 CFR 11.44(c) and the sponsor later decides to discontinue development of the product, when are results due?
- Information on the revised Common Rule (45 CFR Part 46) clinical trial consent form posting requirement has been added to the Support Materials and History, Policies, and Laws pages.
- The Support Materials page has been updated with information on the Request for Information (RFI): Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants issued by the NIH in August 2018. Included are links to resources to help inform comments on this RFI.
- Informational links to the FDA Draft Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (PDF) (September 2018) have been added to the FDAAA 801 and the Final Rule, Support Materials, and Final Rule (42 CFR Part 11) Information pages. Additionally, the FAQ “To which trials do the potential legal consequences described in 42 CFR 11.66 apply?” has been updated with a link to the draft guidance.