Institutional Review Board or Independent Ethics Committee. All the documents the IRB/IEC may need to fulfil its responsibilities, such as the protocol, protocol amendments, informed consent form, information concerning participant recruitment, payment or compensation procedures, etc. will be submitted to the IRB/IEC by the Investigator. The IRB’s/IEC’s written, unconditional approval of the appropriate version of the study protocol and the informed consent form will be in the possession of the Investigator/study site staff prior to the conduct of any protocol-specified procedures. Modifications to the protocol may not be implemented without prior written IRB/IEC approval except when necessary to eliminate immediate hazards to the participants or when the modification involves only logistical or administrative aspects of the study. Such logistical or administrative modifications will be submitted to the IRB/IEC in writing by the Investigator, and a copy of the correspondence to verify the submission will be maintained. The Investigator must inform the IRB/IEC of modifications to the informed consent form or any other documents previously submitted for review/approval and any new information that may adversely affect the safety of the participants or the conduct of the study, provide an annual update and/or request for re-approval, and advise the IRB/IEC when the study has been completed. Any study site-generated documents or forms to be provided to the participant (e.g. information cards, letters from the Investigator), and all forms of study advertising (flyers, brochures, print advertisements, radio or television scripts, etc.) must be approved by the Sponsor or its designee prior to the study site submitting them to the IRB/IEC. Approval from the IRB/IEC must be obtained prior to providing the documents or forms to the participant.
Institutional Review Board or Independent Ethics Committee. The principal investigator must obtain IRB (or IEC) approval for the clinical study prior to enrolling a participant. Initial IRB (or IEC) approval, and all materials approved by the IRB (or IEC) for this study including the participant consent form and recruitment materials must be maintained by the investigator and made available for inspection.
