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INFORMATION FOR

Clinical Trials Project Management

The regulatory landscape for Investigator Initiated research is evolving, and the administrative requirements have become increasingly more complex in recent years. The YCCI PDDF Clinical Trials Project Management (CTPM) team can help Investigators navigate these requirements and run successful studies by establishing milestone-based project timelines and tracking progress toward deliverables. The CTPM team has established infrastructure that can be applied to any Investigator Initiated research project including NIH funded, pharmaceutical partnerships and collaborations, and departmental supported studies. The CTPM team has extensive experience managing large multicenter projects and FDA regulated research.

CTPMs support research throughout the project lifecycle. The scope of work will be dependent upon the study needs, funding mechanism, design, and regulatory oversight. A list of general tasks provided by CTPM are listed below. Study specific needs will be evaluated and established collaboratively with the study team.

Our team is available to meet with Investigators to discuss support services that fit your project needs. Requests for consultation and service proposals can be submitted on the service request form link.

  • Protocol Development & Study Start Up Phase

    • Protocol development in collaboration with appropriate project team members
    • Consent form writing
    • Liaison with funders and/or IP manufacturers
    • Budget development in collaboration with the appropriate business office
    • Contract negotiation and award set up in collaboration with the appropriate OSP team member
    • Central and/or single IRB set up and submission
    • Regulatory document filing & maintenance
    • Supporting IND/IDE submission and maintenance in collaboration with the YCCI IND/IDE team
    • Vendor identification, qualification, set up & oversight
    • Study manual creation in collaboration with relevant subject matter experts
    • Develop study timeline & milestone

  • Site Start Up Phase – For multicenter studies

    • Identify participating sites
    • Support participating site CDA/CTA execution
    • Generate and distribute site regulatory packets
    • Guide participating sites in obtaining IRB approval
    • Schedule & track distribution of study materials (IP, Lab, etc.)
    • Establish study systems access for external site staff
    • Collect and maintain required regulatory documents from participating sites
    • Provide formal site activation documentation

  • Enrollment & Maintenance Phase

    • Lead & document regular study meetings
    • Participate in fiscal management and oversight
    • Facilitate ancillary meetings & and provide minutes
    • Reconcile investigator invoices
    • Perform vendor management
    • Track and record study supply shipping (IP, Lab, etc.)
    • Regulatory document maintenance reconciliation
    • Oversee pharmacovigilance (Adverse Event Reporting & Updated Safety Information Management)
    • Create & distribute regular study correspondence including newsletters
    • Generate study enrollment reports
    • Complete funder & stakeholder reporting
    • Track & update study timelines
    • Support IND/IDE reporting & maintenance Submissions
    • Draft & distribute protocol amendments & supporting document updates

  • Study Close Out

    • Regulatory file reconciliation
    • Participating site support of close out activities
    • Facilitate close out reporting requirements

Request Service Now!