Finding 2022-006 Identification of the Federal Program: Federal Agency: U.S. Department of Health and Human Services, United States Department of Defense Assistance Listing: Various ? Research & Development (R&D) Cluster Pass-Through Grantor: Various Pass-Through Award Number: Various Pass-Through ...
Finding 2022-006 Identification of the Federal Program: Federal Agency: U.S. Department of Health and Human Services, United States Department of Defense Assistance Listing: Various ? Research & Development (R&D) Cluster Pass-Through Grantor: Various Pass-Through Award Number: Various Pass-Through Award Period: 1/1/2022-12/31/2022 Summary of the finding: Management did not retain evidence to support their review over the patient data submitted to Sponsor for the per diem billings from February 1, 2022 to December 31, 2022 was complete and accurate. Corrective action plan: The current attestation memo control will be replaced as follows: There are two categories of study activity that required review and approval by the appropriate individual (i.e., Principal Investigator, Clinical Research Manager (CRM) or a delegate): (1) at the time of enrollment to assure that the study participant met sponsor-defined eligibility requirements and (2) subsequent study activities that may include but are not limited to a study visit, data collection, follow-up phone call, questionnaire completion, laboratory testing, biospecimen collection, or some combination of these. Verification of eligibility at the time of enrollment will continue to be reviewed and approved by the study PI, CRM, or appropriate delegate per sponsor requirements. Documentation is maintained in study-specific binders, per FDA audit standards and internationally-accepted Good Clinical Practice principles to assure that only patients meeting the sponsor?s defined eligibility criteria are enrolled into the study. Review of study activities subsequent to the study participant enrollment will be conducted monthly by the CRM or their delegate. Sponsored Programs Administration (SPA) will prepare and send each CRM a Transaction Report downloaded from the institutional clinical trial management system for each federally funded study, at least quarterly, that includes a listing of study visits associated with enrolled study participants that occurred within the defined period of time. The CRM/delegate will review the report detail provided and, upon approval, sign, and date the report. To assure that the information in the report is consistent with what was submitted to third parties which generates reimbursement, the CRM/delegate will conduct an audit of a sample of patients from a random selection of studies included in the Transaction Report. Each sample will be verified against documentation maintained in the study binder. Audit results affirming document review will be recorded in an audit tracking log which will be retained with the study activity report in their Clinical Trial Office (CTO) file as evidence of their review of study activity for federally funded fixed fee/per patient studies. For those federally funded fixed fee/per patient studies that do not utilize the standard institutional clinical trial management system, a similar study activity report downloaded from the clinical trial management system utilized for the study will be used for review, signed and dated upon approval and kept in the CTO files as evidence of review. Individuals responsible for corrective action: Giacomo DeChellis, Sr. Director, Research Operations, Corewell Health East Timing of corrective action: September 1, 2023 and going forward.