Protocol Registration Submissions Frequently Asked Questions
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?
DAIDS expects that after receiving final approval from all IRBs/ECs/REs/Approving Entity(ies), the CRS will implement approved modifications to the protocol immediately, unless the amendment or LoA states otherwise. Refer to the DAIDS Protocol Registration Manual for additional information regarding amendment and LoA implementation requirements.
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?
The 14 calendar days begin after receipt of the final written IRB/EC/RE/Approving Entity approvals from ALL IRBs/EC/RE/Approving Entities. Per the DAIDS Policy, the 14 calendar begins with the date the written documentation of ALL IRB/EC/RE/Approving Entity approvals was received by the site. Holidays will NOT be counted in the 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?
No. The requirement to submit an amended protocol is for sites that have received initial approval for a previous version from their local IRB/EC. Based on the DAIDS Protocol Registration Policy, the 45/75 day requirement is not dependent on whether a site is registered to a study but rather it is based on the date that the amendment or LoA was approved by DAIDS and distributed to sites. This does not mean that the approved amendment or LoA must be submitted and registered by the DAIDS PRO within 45/75 days. The 45/75 day requirement is the timeline for submission to the local IRB/EC only.
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?
Any protocol amendment (for the main study or sub-study) must be submitted as individual (separate) registration. Individual registration submission is also required for all LoA registrations.
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?
Sites are required to submit continuing review documentation to the DAIDS PRO within 14 calendar days after the receipt of final written documentation of IRB/EC approval.
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?
RwRC Notification indicates that a site may begin using the site-specific ICFs after protocol activation by the appropriate Operations Center, Data Management/Statistical Center or DAIDS Program, if required. However, the site must make the required corrections and submit them to their IRB/EC for review and approval OR must submit justification for why the required corrections will not be made within 120 calendar days of the date the RwRC Notification was issued by the DAIDS PRO.
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?
o, the DAIDS PRO only issues one registration notification per version/language. However, the DAIDS PRO will issue acknowledgement of receipt for the revised Site-specific ICFs.
I've received a disapproval notification but I do not agree with the requested changes. What do I do?
If you would like DAIDS to reconsider disapproval, please submit a disapproval reversal request to the DAIDS PRO. Additional information on submitting a disapproval reversal can be found in section VI. C. ii of the DAIDS Protocol Registration Manual.