The Manual states that once a CRS has received approval from their IRB/EC and other applicable REs/Approving Entities, the amended protocol or LoA and revised site informed consent(s) must be implemented immediately. Can you clarify what is meant by immediately? Is there a window/grace period for things such as administrative tasks or starting to have new consents signed?
The DAIDS Protocol Registration policy says that sites must submit IRB/EC approvals for amendments and LoAs within 14 calendar days of final approval. Our studies are reviewed by multiple IRBs/ECs. Does the 14 days begin after receiving final approval from the ALL IRBs/ECs? Can we begin counting the 14 days beginning with the date received? Will holidays count in the 14 calendar days?
Does the 45/75 day requirement to submit LoAs or full version protocol amendments to the local IRB/EC apply when a site is not yet registered to the study?
How should sites handle protocol amendments for sub-studies? When sites submit an amendment to the DAIDS PRO for the main study should they also submit a separate registration for the sub-study or is the approval for the sub-study assumed to be grandfathered in the parent study amendment approval?
Can you provide clarification regarding the registration requirement for Continuing/Annual Reviews? Are sites required to submit IRB/EC approval of Continuing/Annual Reviews to the DAIDS PRO?
I've received a Registration with Required Corrections (RwRC) notification. Can I start using the site specific ICFs or do I have to wait until the required corrections are made and approved by the IRB/EC?
I have already received a protocol registration notification for my English site-specific ICFs for the current version of protocol xxxx, but I just submitted revised English site-specific ICFs. Will I receive a new registration notification?
I've received a disapproval notification but I do not agree with the requested changes. What do I do?
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This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).