Office of Human Research ServicesResource Director: Henry Durivage, Pharm.D. The Office of Human Research Services (OHRS) provides a range of management and quality control functions, including trial activation and monitoring, a centralized protocol repository, a centralized database of protocol-specific data, lists of currently active trials, protocol status reports, and assistance with complex regulatory issues. Objectives The overall goal of OHRS is to provide central management and oversight functions for coordinating, facilitating and reporting human research results for members of CINJ. Specific objectives are to:
Specific Services Protocol and consent form submission: OHRS staff assist investigators in preparing protocol documents that are consistent in all of the CINJ "template" areas and consent forms that comply with Federal Regulations and IRB standards. Following approval by the Scientific Review Board (SRB), support is provided for protocol formatting, and submission of protocols to appropriate review committees. Pre-study activities: OHRS develops study-specific eligibility check lists and other tools (e.g., calendars, diaries, etc.), helps modify the standard case report form (CRF) to coincide with protocol stipulations, and coordinates the training of personnel who are involved in the research. Activation meetings: OHRS schedules activation meetings for all new studies with the protocol team, which includes the principal investigator, research nurse, research coordinator, treatment nurse, and Research Pharmacy Shared Resource staff. The purpose of this meeting is to review the protocol, define tasks, and identify any special requirements. Communications: The OHRS communicates the status of protocols to CINJ investigators. The list of active CINJ protocols is updated monthly and can be accessed from the CINJ Web page. The protocol list and a Web-based protocol library are maintained by the OHRS. OHRS and the Research Pharmacy coordinated the development of New Jersey Cancer Trial Connect (NJCTC), a Web-based software tool intended to increase information about and participation in oncology clinical trials. All CINJ clinical trials are posted on the NJCTC Web site (www.njctc.org). Patients enter the site to create a personal, secure home page. Patients provide information about their disease and electronically receive a listing of protocols for which they may be eligible. The listing includes a brief description of the study, eligibility criteria, and contact information. Patients receive e-mail notification from NJCTC as new trials become available. The CINJ protocol information contained in NJCTC is kept up to date by the OHRS. Patient screening: CINJ placed an experienced clinical research nurse in the intake office to identify patients for studies. Once a CINJ faculty member has evaluated a patient, the research nurse assists in describing the study to the patient and in answering questions. The research nurse and/or study coordinator ensures that patients meet eligibility requirements, the consent form is signed and dated before enrollment, the protocol enrollment forms are complete, and the required pre-enrollment results are obtained and documented in the medical record. Centralized patient enrollment: All patients enrolled on CINJ trials must be registered through the OHRS. Should a patient be identified for trial participation at a CINJ Oncology Group institution, a completed eligibility checklist and signed consent form are sent by facsimile to OHRS. OHRS personnel complete the registration process with personnel from the CINJ Oncology Group site. A CINJ study coordinator enters all patient information (demographics) into the CINJ Enrollment Database. Conduct of the Trial: A clinical research coordinator creates a calendar of interventions and data collection points upon patient enrollment. These calendars identify required visits and data collection requirements. OHRS staff ensures that the required evaluations are obtained. Reporting serious and/or unexpected adverse events: The OHRS coordinates completion of serious adverse event (SAE) reports and submissions to the IRB and sponsors. The Coordinator of SAE reports is responsible for entering SAE information into the CINJ SAE Database and for providing summary reports on a regular basis to internal and external oversight committees. Data collection and monitoring: Tumor measurements and test results are recorded in the medical record. Data are transcribed onto case report forms. The NCI standard case report forms for phase I studies are modified for CINJ and CINJ Oncology Group therapeutic studies. For CINJ Oncology Group studies, the affiliate institution's research staff completes the case report forms. Data are verified for accuracy by the Clinical Research Coordinators through review of the source documents. Adequacy of monitoring is verified during quality assurance audits of all investigator-initiated studies. OHRS staff monitors CINJ Oncology Group sites during regular (at least quarterly) on-site monitoring visits. Annual quality assurance audits to the CINJ Oncology Group sites are conducted to ensure the integrity of the data and verify the adequacy of the monitoring. Several methods ensure the integrity of the research data. Completed case report forms are kept in locked file cabinets in the OHRS. For NCI phase I studies and cooperative group trials, copies of the case report forms are transmitted to the NCI and cooperative group's offices. Similarly, case report forms completed for industry trials are sent to the appropriate monitoring centers. The Phase I Group utilizes an electronic medical record, Sunrise™ Disease Manager-Oncology. This disease management system will be extended to all investigator-initiated clinical trials in the near future. All database information is automatically backed up, and the back-up tapes are stored off-site in locked, fireproof containers. Reports: Study enrollment and SAE reports are reviewed during weekly OHRS meetings and twice monthly by the HROC. Study enrollment reports are also provided to the principal investigators. Study enrollment reports permit comparison of actual enrollment data to targeted enrollment for investigator-initiated studies. The Chair and Co-Chair of the SRB also review this information. Quality assurance audits: Clinical trials at CINJ have an initiation audit for quality assurance purposes following enrollment of the first two to three patients; thereafter, all investigator-initiated clinical trials are audited by the Regulatory Affairs service area within the OHRS at least annually. Unscheduled audits are conducted if requested by any regulatory body, such as the IRB, the SRB, or HROC or by an investigator. Each audit is conducted by a team of senior members of the Regulatory Affairs Services of OHRS and a research nurse and/or research coordinator. Whenever possible a non-biased investigator is a member of the audit team. None of the members of the audit team are involved directly in the audited trial. The audit is conducted in accordance with a process that checks the research record against source documents, verifies compliance with protocol requirements, and verifies compliance with regulatory requirements. Miscellaneous: The OHRS Regulatory Affairs Services assists with preparation of protocol amendments continuing reviews by the IRB, and annual reports for investigator-held Investigational New Drugs (INDs). The OHRS maintains the CINJ Study Database that tracks protocols from SRB approval to termination. Tracking of due dates for annual IRB and IND reviews ensures that these reports are submitted before the expiration date. The OHRS conducts educational activities for its staff and for those at CINJ Oncology Group-affiliated sites. Contact: Resource Director: Henry Durivage, Pharm.D. |
Shared Resources
Analytical Cytometry / Image Analysis Office of Human Research Services Centralized Education & Training Services Protein Structure Analysis and Modeling Pharmacokinetics / Pharmacodynamics New Jersey Family Medicine Research Network Survey Research and Qualitative Methods All the above Facilities are supported by CINJ’s Cancer Center Support Grant (CCSG)
Additional Shared Resources
Rutgers Center for Operations Research Rutgers University Cell & DNA Repository The Environmental and Occupational Health Sciences Institute (EOHSI) Center for Advanced Biotechnology and Medicine (CABM) Laboratory for Cancer Research Biotechnology Center for Agriculture and the Environment Institute for Advanced Study (IAS)
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