Our Services - Clinical Trial Quality Control
The Comprehensive Clinical Research Unit (CCRU) recognizes the importance of maintaining clinical trial quality and keeping accurate records throughout the life--cycle of a clinical trial. It is a goal of the CCRU to work cooperatively with clinical trial teams to implement a Clinical Trial Quality Management Plan that will assist teams with continual assessment and improvement of their clinical trial activities and processes. The Clinical Trial Quality Management Plan describes the tools that will be used in the Quality Control and Quality Assurance processes. Therefore, we anticipate working with clinical trial teams to develop a Clinical Trial Quality Management Plan that is flexible, involves proactive communication, and demonstrates thorough understanding of Kaiser Permanente Northern California (KPNC) quality requirements.
Benefits
One of the benefits of developing and implementing a Clinical Trial Quality Management Plan includes developing proactive communication among clinical trial team members. This benefits clinical trial teams by encouraging early identification and resolution of clinical trial problems and concerns, and can increase in consistency across clinical trial sites. Implementing a Clinical Trial Quality Management Plan can also encourage conformity with Standard Operating Procedure, Good Clinical Practice (GCP), Good Laboratory Practice, and KPNC policies and procedures. This leads to an overall reduction in external (Sponsor, FDA) and internal (KPNC) data queries, and helps reduce clinical trial closeout time.
Quality Assurance
Quality assurance (QA) covers all policies and systematic actvities implemented within a quality system. QA ensures that data are recorded, analyzed, and recoded in accordance with the protocol and GCP. The use of GCP guidelines ensures ethical and scientific quality standards for the design, conduct, recording, and reporting of IRB approved clinical trials that involve research participants.
Quality Control
Quality control (QC) is a subset of the quality assurance (QA) process. It is comprised of the following activities:
- Detection and measurement of the variability in a clinical trial
- Detection and measurement of the characteristics of clinical trial data generated
- Corrective responses to discrepancies found during the conduct of a trial
Key Quality Indicators
Clinical trial quality requires consistent adherence to measurable and verifiable standards to achieve uniformity of output that satisfies specific customer or user requirements. Key quality indicators during the conduct of clinical research include, but are not limited to, the following:
- Patient eligibility criteria
- Informed consent process
- Serious Adverse Events (SAE) & Adverse Events (AE) ascertainment and management
- Scheduled tests and procedures
- Missed visits, tests, and procedures
- Recording of concomitant medications
- Use of prohibited medications
- Study drug or device administration
Suggested Links
- Food and Drug Administration (FDA) Regulations
- HHS -- 45 CFR 46