If an investigator is noncompliant with the protocol, federal regulations and/or Schulman requirements, the Board may request a letter of explanation from the investigator.
This letter should identify the reasons for the noncompliance and the corrective measures taken to prevent a recurrence.
If the noncompliance is serious or continuing, then the Board may notify the sponsor, CRO/SMO, FDA or OHRP. After review of the serious or continuing noncompliance, the Board will determine the appropriate action to protect the rights and welfare of human subjects. Unresolved and/or past noncompliance issues may delay the review of new study submissions by the investigator.