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 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 YCCI CTPM team has established infrastructure that can be applied to any Investigator Initiated research project including NIH funded, pharmaceutical partnerships, and departmental supported studies. The YCCI CTPM team has extensive experience managing large multicenter projects and FDA regulated research.

CTPMs will 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.

Protocol Development & Study Start Up Phase

• Protocol Development
• Draft Template Consent Forms
• Liaison with Funder and/or IP Manufacturer
• Budget Development in collaboration with the appropriate business office
• Contract Negotiation in collaboration with the appropriate OSP team member
• Central and/or Single IRB Set Up and Submission
• Regulatory Document Filing & Maintenance
• eCRF Design in collaboration with the assigned data manager
• EDC Development & Testing in collaboration with the assigned data manager
• Initial IND/IDE Submission and Maintenance in collaboration with the YCCI IND/IDE team
• Vendor Identification, Set Up & Oversight
• Study Manual Creation in collaboration with relevant subject matter experts
• Develop Study Timeline & Milestone
• ClinicalTrials.gov Set Up & Maintenance

Site Start Up Phase

• Identify Participating Sites
• Participating Site CDA/CTA Execution
• Distribute Site Regulatory Start Up Packets
• Review Site-Specific Consent Form
• Obtain Site IRB Approval
• Schedule & Track Distribution of Study Materials (IP, Lab, etc.)
• Establish Yale internal Systems Access for External Site Staff
• Site Activation Notification

Enrollment & Maintenance Phase

• Lead & Document Regular Study Meetings
• Participate in Fiscal Management & Meetings
• Ancillary Meetings & Minutes
• Reconcile Investigator Invoices
• Vendor Management
• Study Supply Shipping & Tracking (IP, Lab, etc.)
• Regulatory Maintenance Reconciliation
• Pharmacovigilance (Adverse Event Reporting & Updated Safety Information Management)
• Create & Distribute Study Newsletters
• Generate Study Enrollment Reports
• Complete Funder & Stakeholder Reporting
• Track & Update Study Timeline
• IND/IDE Reporting & Maintenance Submissions
• Draft & Distribute Amendments & Supporting Documents

Study Close Out

• Regulatory File Reconciliation & Close Out
• Clinicaltrials.gov Close Out