Page 200 - eBook Version 8 Book 1 of 2 JUL 2022

Internal Quality reviews Research Administration SOP No: R-Reg-104 SOP Title: Internal Quality Reviews
4.3
CLINICAL RESEARCH COORDINATOR
The role of the Clinical Research Coordinator is:
• Ensure that you are added as a “read only” in the eIRB prior to taking part in any quality review for which you are not part of the IRB study team.
• To plan, schedule, and carry out internal quality reviews according to written procedures.
• To ensure that unsatisfactory findings are escalated to the team lead and directors in order that appropriate feedback and corrective and preventative actions are instigated in a timely manner.
• To ensure that internal quality review findings (and associated corrective and preventative actions) are documented, and that these documents are stored safely, securely and made available for inspection.
• To ensure that any serious findings affecting subject safety, or confidentiality, are reported appropriately to the senior director, director, team lead, PI, and to the necessary regulatory bodies and to collaborating parties on the same day as discovery.
PROCESS
Study Approvals
Requisite to any enrollment or subject participation in a clinical trial or research study, the study must have all necessary approvals. At the time of the quality review, the study may or may not be enrolling patients, though verification of the necessary approvals of the study and the study materials should be confirmed in the University of Texas Southwestern (UTSW) electronic institutional review board (eIRB), Velos, and the study regulatory binders.
5. 5.1
1. Login a. b. c. d. e.
2. Login a. b. c.
to eIRB:
Confirm the approval date.
Confirm the expiration date.
Confirm the approval and expiration dates on the consent form(s).
Confirm the approval and expiration dates on the HIPAA form.
Confirm that all recruitment materials and documents intended to be handed out to the subjects are approved by the IRB.
to Velos:
Confirm the performance site approval (PSA) date. Confirm the coverage analysis (CVA) is approved. Confirm the clinical trial agreement (CTA) is approved.
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