515. Continuing w88 online live casino - Submission Requirements for Full Committee w88 online live casino
Updated August 23, 2021
Continuing w88 online live casino (renewal) requests are submitted as subsequentpackagesfor existing projects in IRBNet.
The following submission requirements apply to continuing reviews for w88 online live casino approved by Full Committee Review.
NOTE: Under specific conditions, w88 online live casino approved by Full Committee Reviewmaybe eligible for expedited continuing review (for information, see the Expedited Review section in the IRB Policy Manual Review Types or DHHS Categories of w88 online live casino 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 continuing w88 online live casino.
New Materials for Full Committee Continuing w88 online live casino
Principal Investigators (PIs) mustaddthe followingnewdocuments to a Continuing w88 online live casinopackagefor the existing project:
- Continuing w88 online live casino/Progress Reportresearcher form
- Routine safety reports when no safety 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 IRB promptly via theUnanticipated Problemsreporting form (see IRB Policy Manual for reporting problems to the IRB).
- For clinical 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 w88 online live casino of external AEs.
Signature Requirements for Full Committee Continuing w88 online live casino
- PI signature for the Continuing w88 online live casino 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 w88 online live casino. The attachments vary for each project (for a comprehensive list, see IRB policy for submission requirements for new protocols for Full Committee w88 online live casino) and include the following as applicable:
- Part I, Protocol, and applicable supplemental applications such as for vulnerable populations; federal agency requirements; blood, drug, device w88 online live casino;
- clinical w88 online live casino protocol, investigator brochure, and form 1572 (required for FDA-regulated clinical trials only);
- recruitment materials;
- consent and HIPAA documents, or waiver requests;
- w88 online live casino instruments;
- previously approved amendment packages with related amended materials;
- problem reports previously submitted for assessment/w88 online live casino;
- documentation of external approvals; and
- IRB correspondence.