515. Continuing Review - Submission w88 online live casino for Full Committee Review
Updated August 23, 2021
w88 online live casino review (renewal) requests are submitted as subsequent packages for existing projects in w88 online live casino.
The following submission w88 online live casino apply to continuing reviews for research approved by Full Committee Review.
NOTE: Under specific conditions, research approved by Full Committee w88 online live casino w88 online live casino be eligible for expedited w88 online live casino review (for information, see the Expedited Review section in the IRB Policy Manual Review Types or DHHS Categories of research eligible for review by expedited procedures, 8(a), 8(b), 8(c) or 9).
NOTE: Project amendments may NOT be submitted at the time of w88 online live casino review.
New Materials for Full Committee w88 online live casino Review
Principal Investigators (PIs) w88 online live casino add the w88 online live casino w88 online live casino documents to a w88 online live casino Review w88 online live casino for the existing w88 online live casino:
- w88 online live casino Review/Progress Report researcher w88 online live casino
- Routine w88 online live casino reports when no w88 online live casino concerns are identified and no changes are required (if not previously submitted)
NOTE: Safety reports that involve safety concerns or require substantive changes in study procedures or consent documents must be submitted to the w88 online live casino promptly via the Unanticipated w88 online live casino reporting form (w88 online live casino Manual for reporting problems to the IRB).
- For w88 online live casino investigations only, summary of local and external adverse events (AEs) or adverse device effects not previously submitted, such as when external AEs are not unanticipated problems or sponsor does not require submission of external AEs.
Signature w88 online live casino for Full Committee Continuing Review
- PI signature for the w88 online live casino Review package, obtained electronically through IRBNet
Materials Available for IRB w88 online live casino
Researchers do not need to resubmit project documents because all the documents attached to the project in IRBNet are available for IRB review. The attachments vary for each project (for a comprehensive list, see IRB policy for submission w88 online live casino for new protocols for Full Committee review) and include the following as applicable:
- Part I, Protocol, and applicable supplemental applications such as for vulnerable populations; federal agency w88 online live casino; blood, drug, device research;
- clinical w88 online live casino protocol, investigator brochure, and form 1572 (required for FDA-regulated clinical trials only);
- w88 online live casino;
- w88 online live casino and HIPAA documents, or waiver requests;
- w88 online live casino instruments;
- w88 online live casino approved amendment packages with related amended materials;
- problem reports previously submitted for assessment/w88 online live casino;
- documentation of w88 online live casino approvals; and
- w88 online live casino correspondence.