Study materials submitted for peer review and IRB review still require an additional level of review prior to study commencement if funded by the NIAMS.
If your study is monitored by a NIAMS-appointed monitoring body (e.g., a NIAMS-appointed OSMB/DSMB or NIAMS-appointed Safety Officer(s)), the study materials must be reviewed by the NIAMS and the appointed monitoring body prior to the commencement of recruitment to ensure they are adequate to implement the study. In addition, if changes are made to the study materials after the study has been granted approval, they should be reviewed by the monitoring body, the NIAMS, and the IRB prior to implementing the changes.
If your study is monitored by an internal monitoring body, where the Principal Investigator (PI) selects, assembles, and manages the data and safety monitoring oversight process, the NIAMS still requests all study materials be submitted for review prior to study initiation. The NIAMS conducts an administrative review of the study materials focused on quality to ensure all aspects pertaining to the data and safety monitoring oversight process are outlined clearly and consistently across all study materials. This review will not focus on the scientific or methodological aspects of the study.