Turnaround Time
The standard turnaround time for expedited review of research sites is 2 (two) business days. This turnaround time applies only when a submission is complete. Additionally, site approval will not be provided until the study has been approved, and the Sponsor/CRO and the Board have agreed upon a final template Informed Consent (IC).
If a site submission is received by Schulman IRB after 4 p.m. EST, it will be recorded as received the next business day. Site review and approval turnaround times can be affected by the following issues, which may include but are not limited to:
Missing Curriculum Vitae (CV)
Incomplete Research Site Submission Form
Site’s failure to include FDA audit findings
Site’s failure to include documentation of disciplinary actions against investigators (e.g. state medical board)
Subject compensation issues
IC development and revisions
Board’s decision to place protocol on hold
Sponsor has not yet satisfied the conditions of approval
Principal Investigator/Qualified Investigator conflict of interest