Office of Clinical Research

Rubin 8th Floor
Norris Cotton Cancer Center
One Medical Center Drive
Lebanon, NH 03756
(603) 653-9071

Leadership

Services

  • Provide research support to clinical investigators for the management of clinical trials including investigator-initiated, federally funded, and industry trials.
  • Assist Principal Investigators in the activation and administration of studies.
  • Prepare records for internal and external compliance and quality monitoring and audits.
  • Screening and enrolling patients for clinical trials.
  • Coordinate the completion of participant-specific study requirements.
  • Provide data management and regulatory support for clinical trials.
  • Provide multi-center project management services for investigator-initiated trials.
  • Provide education on clinical trial management to staff and new investigators.
  • Lab has -20º C and -80º C degree freezers for short-term storage; two centrifuges (one refrigerated, one ambient).
  • Procure, process, and ship blood samples the same day as required. Can short-term freeze samples.

Technology

NCCC utilizes an automated IT environment (Velos eResearch) as its central repository for study- and patient-related data. Velos eResearch is a comprehensive, web-based suite of software that addresses many research-related tasks, including Study Management, Patient Management, Document Management, Patient Calendars, and Centralized Reporting.

Service process

  1. Notify OCR, disease-specific, Clinical Research Coordinator or Administrative Director (OCR general number 603-653-9071) when a new clinical trial is being proposed.
  2. Assistance is available for all steps of opening clinical trials including investigator-initiated, federal, and industry-sponsored trials. Confidentiality agreements (CDA), contracts, and budgets are negotiated through the Clinical Trials Office (CTO).
  3. CRCs and regulatory specialists provide complete services (prior to opening a study through close out of a study) including IRB submission, submission, and maintenance of regulatory documents and participant data, coordination with sponsors for site initiation, monitoring, and investigational pharmacy visits. OCR staff work with CTO, CPHS, and sponsors on all aspects of a trial. CRCs and regulatory Specialists provide complete services (from protocol concept to close of a study).
  4. Research Nurses serve as the clinical liaison to assist with informed consent, symptom management, and clinical conduct of the study.

Structure and support

Clinical Cancer Review Committee (CCRC)

Provides required peer review of scientific merit prior to IRB review. Reviews clinical research protocols for treatment, prevention, control or intervention of cancer and protocol amendments

NCCC Data, Safety Monitoring, and Accrual Committee (DSMAC)

Provides required peer review of clinical research protocols for which a Dartmouth investigator is both investigator and sponsor of the protocol. Review toxicity patterns, data integrity, protocol adherence, and progress toward study objectives. Reviews study accrual.

Clinical Trials Investigational Order Set Committee (CTIOSC)

Provides a required review of drug order sets for clinical trials prior to study activation

Cancer Clinical Research Quality Improvement Committee (QIC)

Focuses on continuous clinical research process improvement at the Norris Cotton Cancer Center. Analyzes trends in the quality of research by quarterly reviews of protocol deviation reports, local serious adverse event reports, ongoing corrective and preventative actions plans, reports from research ancillary support services, and reports from PIs, NPs, Clinical Research Coordinators, Research Nurses, Regulatory staff, and administrators.