Clinical Trials and Staff - Operational Support
It is the CCRU's mission to support Kaiser Permanente Northern California (KPNC) clinical trial researchers in the development and execution of successful clinical trials. As such, the CCRU aims to:
- Assist with the feasibility review of clinical trials and proposals using web-based approaches
- Apply strategies to enhance collaborations within KPNC, with sponsors, and with other partners in research
- Help determine the staff and infrastructure requirements for conducting a successful clinical trial
- Provide assistance during the interview and hiring process of new research personnel
- Implement the Clinical Project Process (CPP) as a guide for clinical trial realization
Clinical Project Process (CPP)
The CPP is a highly detailed and fully developed clinical trial management process map that, when successful, is the cornerstone of clinical trial development and an effective guide during clinical trial progression. The CPP addresses specific technical tasks involved in clinical trial management that benefit both experienced and less experienced clinical research staff. There is a specific focus on the need to anticipate, understand, and implement detailed research project management activities in a proactive manner.
Stages of the CPP:
- Pre-planning – business plan, trial synopsis, Go-No Go clinical trial decision making
- Planning – final determination of endpoints and statistical methodology, protocol development and finalization, site selection, regulatory and contract procedures, training and site initiation
- Implementation – enrollment, data collection, data entry, snapshot of safety data, data hygiene, maintenance of essential documents, product safeguard and accountability
- Data Analysis – snapshot of efficacy, endpoints analysis, data validation, final statistical report, data lock, study termination, site closure, final IRB report
- Clinical Trial Data Conclusion – final clinical trial report, data release and presentation
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