Congratulations! Your research may begin. Over the course of the study, you will need to submit continuing reviews, amendments, report AEs/SAEs, and submit to monitoring and audits. There are also ongoing educational offerings.
Once your study has been approved by the appropriate committees, your research may begin. Over the course of the study, you may need to submit continuing reviews, amendments, report AEs/SAEs, and submit to monitoring and audits.
Amendments: ANY changes to an IRB approved protocol require the submission of an amendment for IRB review and approval PRIOR to initiating those changes.
Continuing Reviews: Reports the progress of approved research to the IRB. The IRB determines the approval period (based on risk to subjects).
Reportable Events: Regulations require an organization to have written procedures for ensuring prompt reporting of changes in research activity; unanticipated problems involving risk to subjects or others; and any instances of serious or continuing non-compliance to the IRB, organizational officials, and applicable federal agencies.
Subject to Monitoring and Audits: Audits could be internal (Corporate Compliance) or external (FDA, OHRP, NIH, Sponsor, etc.)