Ethics Committee and Institutional Review Board (IRB) support
Ethics Committee and Institutional Review Board (IRB) support involves providing assistance and guidance to researchers, sponsors, and clinical trial sites in the process of obtaining ethical and regulatory approvals for their clinical trials.
Ethics Committees (ECs) or Institutional Review Boards (IRBs) are independent groups responsible for reviewing and approving clinical trials’ design, methods, and ethical aspects. We ensure that trials are conducted in a manner that protects the rights, safety, and well-being of the participants. The “Ethics Committee and IRB support” service offered by GCT encompasses various tasks:
Preparation of Submission Documents: GCT helps in preparing the necessary documentation required for submission to the EC/IRB. This may include the research protocol, informed consent forms, investigator’s brochure, patient information sheets, and other relevant documents.
Regulatory Compliance: GCT ensures that all documents and procedures align with local and international regulations and guidelines governing clinical research.
Submission Process: GCT assists in submitting the documents to the appropriate EC/IRB, ensuring they are complete and well-organized. We may track the submission progress and address any questions or concerns the committee raises.
Communication: GCT may act as an intermediary between the study sponsor, investigators, and the EC/IRB, facilitating effective communication and addressing any queries or feedback from the committee.
Protocol Amendments: If there are any changes to the study protocol, GCT helps in preparing and submitting protocol amendments for review and approval by the EC/IRB.
Timelines: GCT ensures that the EC/IRB approval process progresses within the expected timelines.
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