Turn-Around-Time

Schulman IRB will provide two business day turn around (received date to initial approval sent date) on all complete and accurate research site submissions for a previously approved protocol when the Sponsor Approval Letter has been sent out. If a site submission is received by Schulman IRB after 4 p.m. EST it will be recorded as received the next business day. If a site's submission has any deficiencies, the two business day turn around time cannot be guaranteed.

Examples of common submission deficiencies include, but are not limited to:
  • Incomplete or missing 1572
  • Missing Curriculum Vitae
  • Incomplete Research Site Submission Form
  • Principal Investigator conflict of interest
  • Enrollment via Legally Authorized Representative when prohibited by protocol
  • Enrollment from vulnerable groups when prohibited by protocol
  • Follow-up on FDA audit findings
  • Disciplinary actions against investigators (e.g. state medical board)
  • Compensation issues
  • Informed consent document (ICD) being revised due to risk
  • ICD awaiting sponsor/CRO sign-off
  • Protocol on hold
  • Sponsor has not satisfied the conditions of approval
  • Site specific language added to the ICD