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Clinical Research Support Office/CRSO

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i) Protocol, Informed Consent, Data and Safety Monitoring Plans

The CCTS and IRB have 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 (iRIS) with appropriate permission configuration, metrics, and report generation. Protocol writing and clinical systems integration functions are 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. 

With the goal to make study conduct transparent and enable oversight, the tools and procedures for authoring the protocol and the informed consent facilitate robust documents within an integrated infrastructure.  The DSMP tools, data tables, calendar, milestones, and reporting functions are all in place from the outset of protocol conduct, making them accessible to both the study team and the oversight team so as to simplify assessments of safety, performance, and compliance. Protocol and Informed Consent authoring are guided by the IRB Policies and Procedures, and significantly assisted by the efforts of the Clinical and Translational Research Facilitation Office and its Protocol Navigation program. 

    1. Protocol and Informed Consent Authoring, and Translation. Support is enhanced by:
      • Document management in a centralized web-based database,
      • Access to the IRB database for investigator, drug and protocol history,
      • IRB-approved template language to support consistent protocol writing,
      • Tools to support reading level assessment integrated into the submission workflow,
      • Functionality to incorporate pre-structured DSMPs and risk assessments,
      • Visibility of protocol drafts pre-submission to appropriate content experts for development support including scientific review, biostatistics design, Clinical Research Officer pre-review of DSMP, Informed Consent editors, or other assistance with protocol development and feasibility,
      • A set of informed consent templates,
      • Step-by-step instructions accompanying the protocol submission template,
      • A hyperlink to text reading-level assessment software,
      • Informed Consent editing tools and editors using a Plain Language model,
      • Informed Consent Form writing workshops and lay language assessment tools,
      • Focus groups devoted to participant's perceptions of elements of recruitment and informed consent,
      • Use of participant feedback and outcome measures that assess the utility of specific practices,
      • Translation services are available to investigators for creation of translated-certified informed consent forms,
    2. Development of Data and Safety Monitoring Plans (DSMPs). 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 NIH Institutes/Centers, or industry sponsors. Assistance is provided to Investigators through:
      • The iRIS protocol application provides a framework for developing a DSMP, a required component of every protocol. Assistance completing this section is provided during Protocol Navigation with the Clinical and Translational Research Facilitation Office staff. The Clinical Research Officer is an additional resource in development and review of the DSMP.
      • Protocols associated with IND submissions have additional requirements related to reporting to the Food and Drug Administration.
      • The benefits of uniform pre-review of the DSMP include:
        • Consistent application of policy across every protocol,
        • Consistent standards for appropriate protocol design and implementation,
        • Consistent risk assessment for improved participant safety,
        • Consistent opportunities for all investigators to make key DSMP revisions prior to full Board review, facilitating the review process itself,
        • Opportunities to identify and address educational needs proactively.
        • 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 may be developed with interdisciplinary assistance from the CCTS cores, coordinated by the Translational Research Facilitation Office, the CRSO Clinical Research Officer and Clinical Research Specialist, and other content experts or consultants as appropriate. The Program of IND Assistance (PIA) is a resource to help investigators get started in this process. 
Site Map Investigators Log-ini) Protocol, Informed Consent, Data and Safety Monitoring PlansThe CCTS and IRB have invested strategically in the vision of a system affording the ability to route wo