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School of Medicine
The Clinical Data and Protocol Management (CDPM) provides numerous services to faculty and staff conducting oncology research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) including:
- The Protocol Library – a web-based system containing all current, approved cancer protocols
- The Clinical Research Management System (CRMS), a comprehensive database of all oncology studies, accrual, regulatory status, and research staff
- The Forum - an electronic system which tracks documents and meeting outcomes in support of the Clinical Research Review Committee (CRC) which reviews all SKCCC clinical trials in accordance with NCI Cancer Center
Support Grant Guidelines
The CDPM Website -- a one-stop resource containing news and information critical to the conduct of clinical research at SKCCC
The CDPM also provides administrative support for Core committees (CRC, DSMC – Data Safety Monitoring Committee), ongoing educational and training opportunities, regulatory expertise, and quality assurance monitoring and auditing.
The Clinical Data and Protocol Management has overall responsibility for the performance of cancer trials within the SKCCC. The specific objectives of the Core are:
- Development and promulgation of standards for clinical research
- Implementation and coordination of research studies in collaboration with principal investigators
- Adherence to standards including supervision and performance review of research personnel
- Assistance to investigators in preparation of protocols, consent, case report forms (CRFs), and orders
- Preparation of materials for Clinical Research Review Committee (CRC)
- Acting as liaison between research staff and the Institutional Review Board (IRB)
- Auditing of clinical trials
- Education of research staff
- Maintenance and continued development of the Clinical Research Management System database
- Evaluation and direction of clinical research efforts within the Center.
- Facilitation of the development of clinical research studies
- Clinical trials management and support
- Monitoring of databases and study accrual
- Assurance of quality (QA) of clinical trials
- Review of amendments and serious adverse events
- Support of collaborations and provision of regulatory support
- Research administration and reporting
- Auditing trials to assure compliance with protocol treatment, measurement of effect, and adherence to regulatory requirements
Faculty Director: Michael Carducci, M.D.
Program Manager: Janet Heussner
CDPM Contact: 410-955-8866