The standard turnaround time for expedited review of research sites is 1 business day.
This turnaround time applies only when a submission is complete and — if there is any — followup resolved. Additionally, site approval will not be provided until the study has been approved, and the informed consent finalized.
Site submissions are processed by expedited review daily or may be referred for full Board review under certain circumstances.
Site review and approval turnaround times can be affected by the following issues, which may include:
- Missing, outdated or incomplete Curriculum Vitae (CV) – CVs must reflect experience, be signed and dated within the past 2 years.
- 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
- Informed consent 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
For more information, please review our key Turnaround Times.