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Clinical Trial Compliance Checks (performed on fully executed Agreements)

After an Industry-Funded/Sponsored Clinical Trial Agreement has been negotiated and fully executed by the OIC (Office of Industry Contracting), the record is available in the ALICE system.

Clinical trial Agreements that are funded by Federal/Cooperative Group/Consortia/Foundation sources are negotiated by the OSR (Office of Sponsored Research), with study information available for review in the RAMSeS and CRMS systems.

Prior to release of a project account/funds by the OSR (Office of Sponsored Research), a series of checks are made to ensure that Federal, institutional, and contractual requirements have been met.

Compliance checks that are performed within OCT include:

  1. IRB Approval – For New Agreements, the IRB application must have been submitted, reviewed, and approved. For Contract Amendments, IRB approval must be current. Email reminders are sent to study personnel if IRB approval has expired.
  2. Conflict of Interest – Research personnel for whom a COI Disclosure is required must have responded to the request in the AIR (Activities, Interests and Relationships) System. Any disclosures deemed to be an actual or perceived conflict will be managed by the COI Office; any such conflicts must be fully resolved. All research personnel listed on an IRB application must also complete Conflict of Interest Training. Email reminders (and instructions for access/completion) are sent to individuals who are not compliant with COI requirements.
  3. Good Clinical Practice – For studies/personnel subject to Good Clinical Practice Training, it must have been completed and current in accordance with the CITI training modules required by UNC-CH. Email reminders (and instructions for access/transfer from another institution/completion) are sent to individuals lacking GCP training or whose training has expired.
  4. Subject Injury and Subject Cost Language – The language relating to Compensation for Subject Injury and to Costs of Study Participation must be congruent between the executed Agreement and IRB-approved ICF (Informed Consent Form). The OCT provides template language to study personnel who are responsible for drafting the ICF and for routing it to Sponsors and, when applicable, to external IRBs upon whom the UNC-CH IRB may have ceded oversight. Emails are sent to personnel if discrepancies are found between the contracted language in the Agreement and the UNC-required language for resolution.
  5. BCA (Billing Coverage Analysis) – Study personnel responsible for submitting a BCA for review must have completed the process in CRMS (Clinical Research Management System) for study procedures/activities that will be provided/billed by UNC Hospitals. Even for studies that will not incur hospital charges, the need for/waiver of a BCA must be adjudicated and recorded. Tracking and correspondence related to BCA development and submission is managed by the OCT-Clinical Research and Billing Compliance. For more information, see: Billing Coverage Analysis.
  6. PI Certification of the IPF (Internal Processing Form) and completion of COI disclosure in RAMSeS. Note: There are two requirements for COI disclosure: one is associated with the IRB application and a second is associated with the RAMSeS IPF record.  Both must have been submitted, reviewed and resolved by the COI Office. Emails are sent to PIs who have not completed both RAMSeS PI Certification and COI Disclosure.

OCT tracks the progress of each compliance issue and keeps study personnel and OSR informed as to missing or expired information and issues preventing sign-off. Instructions for completing GCP/COI training, COI disclosure, the BCA, RAMSeS certification, and correction of subject injury or cost language are provided to personnel, and resolution of each criterion is recorded in various electronic management systems for tracking and reporting purposes.