Clinical Research Support Office/CRSO

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i) Protocol, Informed Consent, Data and Safety Monitoring Plans, and IRB Liaison Services

The CRSO has invested strategically in the vision of a system affording the ability to route workflow and assistance, and capture the protocol design, schedule of events, regulatory events schedule, compliance milestones, and study conduct data in a single transparent database with appropriate permission configuration, metrics, and report generation. The objective is to allow the Informed Consent oversight process, DSMP tools, data tables, calendar, milestones, and reports to be set up at the outset of the protocol, making them accessible to both the study team and the oversight team so as to simplify assessments of safety, performance, and compliance.

    1. Protocol and Informed Consent authoringat Rockefeller University Hospital is guided by the IRB Policies and Procedures, and further assisted by on-line guidance including:
      • Step-by-step instructions accompanying the protocol submission template,
      • An informed consent template
      • A hyperlink to text reading-level assessment software,
      • A Rockefeller University-specific educational module, hosted for Rockefeller University on the CITIprogram website that reviews the appropriate use of translators, short forms, and other advanced aspects of Informed Consent
      • Protocol writing and clinical systems integration functions will be dramatically enhanced with the adoption of the iRIS/iMEDRIS application suite, which is an electronic clinical research management infrastructure that improves and streamlines workflow and transparency of information. Support will be enhanced by:
        • Document management in a centralized web-based database;
        • Permits access to IRB database for investigator, drug and protocol history
        • Provides IRB approved template language to support consistent protocol writing;
        • Supports reading level assessment integrated into the submission workflow;
        • Permits incorporation of pre-structured DSMPs and risk assessments;
        • Routing of protocols pre-submission to appropriate development support such as the scientific review committee, biostatistics design, Clinical Research Support DSMP pre-review, Informed Consent editors, or PCIR Nurse/Coordinators to assist in protocol development and feasibility,
    2. Assistance to Investigators in the Development of Data and Safety Monitoring Plans (DSMPs)is currently provided in several ways. Investigators are required to describe a plan conforming to established guidance for essential elements of a DSMP as derived from Notice 98-084 and Notice 00-038, with additional guidance for protocols overseen by NCI, NHBL or industry sponsors.

Protocols associated with IND submissions have additional requirements related to reporting to the Food and Drug Administration.

Information and step-by-step guidance related to DSMPs is provided on the Rockefeller University Hospital internal website. Direct one-on-one assistance is provided in an optional pre-submission consultation with the Clinical Research Officer, and utilizing the pending software upgrade, pre-review is structured into the workflow of the protocol submission process.

The benefits of uniform pre-review include:

      1. Consistent application of policy across every protocol,
      2. Consistent standards for appropriate protocol design and implementation
      3. Consistent risk assessment for improved participant safety,
      4. Consistent opportunities for all investigators to make key DSMP revisions prior to full Board review, facilitating the review process itself,
      5. Opportunities to identify and address educational needs proactively.
      6. Opportunities to collect quality assurance data to address systemic changes in a timely fashion.

Protocols containing test articles regulated under Investigational New Drug applications in which the investigator is the IND-Sponsor will be managed through a new mechanism under development following the model of the University of Minnesota. The Program of IND Assistance (PIA) will provide support in the preparation and submission of IND-related documents and requiring assistance in tracking IND-related activities and correspondence. Based on the published experience at the University of Minnesota, we anticipate that this program will greatly facilitate investigator's efforts to understand the FDA's rules and regulations and fully comply with them.