Institutional Review Boards Sample Clauses

Institutional Review Boards. With the relevant Xxxx’x approval, a Lecturer may submit research projects for Institutional Review Board (IRB) approval during the term of their appointment. As part of such submission, the Lecturer will have access to the same materials and support as Statute 11.1 Faculty.
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Institutional Review Boards. ‌ The protocol and consent form will be reviewed and approved by the IRB of each participating center prior to study initiation. SAEs regardless of causality will be reported to the IRB in accordance with the standard operating procedures and policies of the IRB. The Investigator will keep the IRB informed as to the progress of the study. The Investigator will obtain assurance of IRB compliance with regulations. Any documents that the IRB may need to fulfill its responsibilities (such as protocol, protocol amendments, Investigator’s Brochure, consent forms, information concerning subject recruitment, payment or compensation procedures, or other pertinent information) will be submitted to the IRB. The IRB’s written unconditional approval of the study protocol and the informed consent form will be in the possession of the Investigator before the study is initiated. The IRB’s unconditional approval statement will be transmitted by the Investigator to the Sponsor prior to the shipment of study supplies to the site. This approval must refer to the study by exact protocol title and number and should identify the documents reviewed and the date of review. Protocol and/or informed consent modifications or changes may not be initiated without prior written IRB approval except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the study. Such modifications will be submitted to the IRB and written verification that the modification was submitted and subsequently approved should be obtained. The IRB must be informed of revisions to other documents originally submitted for review; serious and/or unexpected adverse experiences occurring during the study in accordance with the standard operating procedures and policies of the IRB; new information that may affect adversely the safety of the subjects or the conduct of the study; an annual update and/or request for re-approval; and when the study has been completed.
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Related to Institutional Review Boards

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