Examples of Designated reviewers in a sentence
Designated reviewers and supervisors in charge of final Elevation Certificate review and approval are directed to track Elevation Certificate errors to help pinpoint issues that may require further training.
Designated reviewers may only approve research that meets the criteria for approval outlined in 45 CFR46.111 and must ensure the study meets the requirement for informed consent outlined in 45 CFR46.116 and 46.117 unless the study meets the requirements for waiver of consent or documentation.
Designated reviewers are assigned by the IACUC Chair with theassignments distributed among all IACUC members.
Designated reviewers will review the proposed modification and either grant full approval, conditional approval or require full board review at the next convened meeting (or an emergency meeting may be convened if warranted).
Designated reviewers are appointed by the Team manager and recorded on the Safeguard system.
Designated reviewers are generally HSD staff members who are also IRB members and who have been provided with delegation of authority from an IRB Chair (TEMPLATE Delegated IRB Authority Memorandum) when they are deemed by an HSD manager to be sufficiently trained and experienced.
Designated reviewers can include the LOC (FHI 360) CRM, SDMC Clinical Data Manager (CDM), Behavioral Research Working Team Members Group (BRWG) protocol team members, MTN Safety Physicians, LC designee, and the MTN Director of Pharmacy Affairs.
Designated reviewers have one of three options when reviewing revised protocols: 1) Approve the protocol if both designated reviewers agree; 2) Request additional information from the PI to secure approval; or 3) Request a full IACUC review.
Designated reviewers cannot withhold approvals; only a fully convened IACUC meeting may withhold the approval of a protocol.
Designated reviewer(s) either contact the PI directly to discuss the protocol, addendum or renewal, or forward issues and requests for clarifications to the IACUC administrator, who compiles and sends them to the PI.