• Clinical Management & Research Support

    The Clinical Management and Research Support Core (CMRSC) provides expertise in the management of clinical trials from protocol development through study closure. The team of principal investigators, clinical research coordinators, clinical research nurses, advance practice nurses, data management specialists, medical writers, and administrative support provides a high level of support in the operation of all types of clinical trials.

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    + Protocol Development

    • Assistance with protocol writing
    • Protocol review and approval process
    • IRB submission
    • Informed consent
    • Investigator and site initiation meetings
    • Development of case report forms
    • Pre-printed study orders
    • Investigational New Drug (IND) application
    • Study closure

    + Subject Management

    • Eligibility
    • Subject recruitment
    • Registration
    • Required observations
    • Data management and submission
    • Patient brochures and educational materials
    • Coordination of protocol visits
    • Adverse events reporting
    • Specimen collecting and handing
    • Clinical management and support of the subject

    + Regulatory

    • Protocol amendments and continuing reviews
    • Regulatory files and subject records
    • Interactions with the IRB
    • Site/Sponsor/Research Office communications
    • Quality assurance/audits/monitor visits
    • Data Safety Monitoring Board
    • Adverse Event and Serious Adverse Event reporting (IRB, FDA, AdEERS)

    + Administrative

    • Secretarial support
    • Supplies, equipment
    • Database support