Page 299 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Internal Audits Research Administration SOP No: R106 SOP Title: Internal Audits
4.3
CLINICAL RESEARCH COORDINATOR
The role of the Clinical Research Coordinator is:
• To plan, schedule and carry out internal audits according to written procedures.
• To ensure that unsatisfactory findings are fed back to team members and that appropriate feedback and corrective and preventative actions are instigated in a timely manner.
• To ensure that internal audit 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 consent or confidentiality, and sample or data integrity are reported appropriately to the PI, to the necessary regulatory bodies and to collaborating parties.
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 audit, 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
5. 5.1
5.2
Selection Process
Southwestern (UTSW) regulatory binders.
electronic institutional review board (eIRB), Velos, and the study
the approval date.
the expiration date.
the approval and expiration dates on the consent form(s). the approval and expiration dates on the HIPAA form.
that all recruitment materials and documents intended to be out to the subjects are approved by the IRB.
It is the goal of every study team to be “audit ready”. In line with this expectation, it is strongly recommended that an internal audit or review be completed for each new
1. Login
a. Confirm
b. Confirm
c. Confirm
d. Confirm
e. Confirm
2. Login
to eIRB:
handed to Velos:
a. Confirm
b. Confirm
the performance site approval (PSA) date. the coverage analysis (CVA) is approved.
the clinical trial agreement (CTA) is approved.
c. Confirm
3. Review the regulatory binder for the site activation letter from the sponsor.
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