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Internal Quality reviews Research Administration SOP No: R-Reg-104 SOP Title: Internal Quality Reviews
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PURPOSE
The purpose of the current standard operating procedure (SOP) is to outline the procedures to be followed when conducting internal quality reviews on clinical trial studies at Children’s Health Research Administration (RA).
INTRODUCTION
The ongoing mission to make children’s lives better through research cannot be achieved without integrity and thorough review of clinical data. The purpose of clinical research is advancing medical knowledge in large part through testing the safety and efficacy of investigational treatments. The product of clinical research is only as valid as the efforts and steps taken to collect, review, and resolve data accurately. Therefore, the RA incorporates regular quality reviews designed to establish the extent of compliance, predominantly through conformity to documented procedures and standards. Additionally, a means for guidance on corrective and preventative actions following an quality review, support the commitment to quality research to which our department is vested.
SCOPE
This SOP applies to all clinical research staff on the study team that conduct clinical research at Children’s Medical Center at Dallas. The study team as defined in Children’s Health Clinical Practice Policy 7.12, Responsibilities of the Research Team will ensure adherence to this SOP.
This SOP covers internal quality reviews carried out within RA which examine the trail of a subject’s participation into a study from start to finish so that all contributable activities (consent, enrollment, drug administration, adverse events monitoring, sample collection) are quality reviewed for conformance.
RESPONSIBILITIES Study Approvals
The study team will ensure that all applicable study approvals have been requested and granted.
Study team
The study team will ensure that a regular internal quality review program is developed and implemented by appropriately trained individuals within the research administration team. Personnel responsible for actions from quality review findings can be:
• Principal Investigator (PI) and/or Co-Investigator (Co-I)
• Clinical Research Coordinator (CRC)
• Investigational Drug Service (IDS) Team (if applicable)
• Research Laboratory staff (if applicable).
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