2.4 Communication with IRB/IEC

2.4.1 Submission to the IRB/IEC may be made by the investigator/institution or sponsor in accordance with applicable regulatory requirements (see section 1.1).

2.4.2 Before initiating a trial, the investigator/institution should have a documented and dated approval/favourable opinion from the IRB/IEC for the trial protocol, informed consent materials, participant recruitment procedures (e.g., advertisements) and any other trial-related information to be provided to participants.

2.4.3 As part of the investigator’s/ institution’s or sponsor’s (in accordance with applicable regulatory requirements) submission to the IRB/IEC, a current copy of the Investigator’s Brochure or basic product information brochure should be provided (see Appendix A, section A.1.1). If the Investigator’s Brochure or basic product information brochure is updated during the trial, the IRB/IEC should receive the current version in accordance with applicable regulatory requirements.

2.4.4 As the trial progresses, the investigator/institution or sponsor should provide any updates to the participant information to the IRB/IEC in accordance with applicable regulatory requirements.

2.4.5 The investigator or the sponsor should submit documented summaries of the trial status to the IRB/IEC in accordance with local regulatory requirements or upon request.

2.4.6 The investigator or the sponsor should promptly communicate to the IRB/IEC (see section 1.4.8) and, where applicable, to the institution any changes significantly affecting the conduct of the trial and/or increasing the risk to participants.

Published with Nuclino