Clinical Research Operations
The Office of the Clinical Director serves as the interface between CCR clinical investigators and the NIH Clinical Center where CCR clinical trials take place. The Clinical Director, Dr. William L. Dahut, oversees and assures the quality of medical care delivered to patients treated on CCR clinical trials. The Office of the Clinical Director is also responsible for:
- Biostatistical expertise for clinical trial design and analysis
- Administrative support for the protocol review and monitoring process
- Training and continuing education for clinical research staff
- Data management, auditing and monitoring of NCI intramural and multi-institutional trials
- An outreach program to promote patient accrual
- Informatics for data collection and storage
This site was developed to support CCR clinical operations staff and is organized into 9 sections:
- Biostatistics and Data Management – Consultation for clinical trial design, review, conduct, monitoring and analysis
- Clinical Informatics – Links to login pages, policies, applications support, updates, training schedules, user groups and other resources
- Education and Training – New hire orientation, continuing education, seminars and helpful resources
- IRB Administrative Office – Supports the activities of the NCI Institutional Review Board (IRB).
- Patient Recruitment – Promotes CCR clinical trials to cancer patients and their referring physicians
- Policies and SOPs – Access to NCI-CCR policies, standard operating procedures (SOPs), and forms for clinical protocols.
- Protocol Support Office (PSO) – Assistance to CCR clinical investigators in preparing and submitting clinical protocols to various regulatory bodies such as the IRB, FDA, OBA, and IBC through the lifetime of the protocol.
- Forms and Templates – NCI-CCR Protocol Template and Guidelines, templates for Informed Consent, Deviations and Violations, Human Subjects Research
- Resources -- Clinical trials resources, professional associations, training, terminology, and MORE . . .
