Resource Explorer

Below is a partial list of responsibilities related to being the principal investigator and sponsor of investigator-initiated multi-center research. Please note that the management of this type of trial is costly so should be appropriately budgeted. The UVA SOM Clinical Trials Unit provides support for the below activities as a cost-recovery service. The FDA website should be referenced for more information and guidance as needed.

Manage regulatory requirements

• Submit IND or IDE application to FDA
• Adverse Event Management
• Maintain a Trial Master File, including documentation of IRB approval at each site prior to them initiating study activities, other regulatory approvals, and ongoing training of all study personnel
• ClinicalTrials.gov registration and maintenance
• Submit annual IND or IDE report to FDA

Study Development Protocol development

• Amendment development including summary of changes
• Create study procedures manual, specimen collection and management/lab manual, subject diary or other supporting documents

Training

• Produce training materials
• Perform site assessments/site selection
• Conduct Site Initiation Visit (SIV) and ongoing training for all sites involved
• Document amendment distribution, training, and implementation

Monitor accruals

• Regular review of site accrual log(s)
• Produce aggregate study accrual reports
• Address accrual issues

Data Management

• Develop Data Monitoring Plan(s) and establish Data Safety Monitoring Committee (DSMC) per plan
• Create case report forms (CRFs) and CRF completion guidelines
• Create requisitions or source documents
• Perform data checks to ensure consistency in data entry
• Produce data files for analysis
• Conduct interim monitoring visits
• Generate monitoring reports

Communication

• Coordinate regular teleconferences
• Document and distribute meeting minutes
• Disseminate updated materials (protocol, manuals) to participating sites

Manage study progress

• Track study milestones
• Perform registration/randomization of subjects
• Reporting: Produce and submit DSMC reports
• Adverse Event, DLT and other safety reports to regulatory bodies and/or funding sponsor
• Prepare and submit accrual or progress reports to funding sponsor

Contracting

• Develop and negotiate budget
• Establish contract or subcontract as needed with funding entity, participating centers, vendors, etc
• Manage study invoices and payments per all contract terms