If an investigator is non-compliant with 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 non-compliance and the corrective measures taken to prevent a recurrence. If the non-compliance is serious or recurrent, then the Board may notify the sponsor and/or CRO/SMO, and may consider withdrawing approval to conduct the study. If approval is withdrawn, the Board will notify the investigator, sponsor, CRO/SMO, FDA and/or OHRP, if applicable, of its decision. Unresolved compliance issues may delay the review of new study submissions by the investigator.