Investigator Noncompliance

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.