Notification of Decision
Notification of Decision
The PIs shall be notified in writing of the NREB decisions up to two (2) weeks after the meetings, where applicable, after the complete review of the protocols. If there are outstanding issues to address for complete review, the appropriate representatives will be contacted, after the review meeting, to provide those additional materials or address those additional concerns, where applicable.
Decision Type
After the review of applications by the NREB, the decision types to be communicated by the Secretariat shall be one of the below categories:
- Approved: The submission satisfies all requirements in accordance with the NREB SoP and Good Clinical Practice (GCP), including country-specific ethical and regulatory principles, and the protections of human subjects.
- Not Approved: The submission failed to satisfy all requirements in accordance with the NREB’s SoPs and GCP.
- For Consideration
- Provisional Approval: an approval requiring the investigator to commence the study while addressing minor concerns.
- Pending Approval: The submission partially satisfied the requirements in accordance with the NREB’s SoPs and GCP. In such a situation, stipulations and/or concerns will be generated and submitted to the PI or approved designate for redress. The stipulations and/or concerns must be addressed to the satisfaction of the NREB prior to the granting of approval for the commencement of the study.