Project and Trial Operation Management
The Data Coordination Unit has the ability to provide an all-inclusive approach to clinical trial collaboration and management. The Project Management component includes experienced staff who have been involved in all aspects of clinical trial research from initial trial design through trial close-out and collaboration on manuscripts. The Project Management group is focused particularly on providing clinical trial leadership with up-to-date information on trial management matters, and serving as a resource for dissemination of information with regard to directives and guidance from regulatory entities.
Services that the Project Management group provides are:
- Collaboration on study design with a particular focus toward adherence to Good Clinical Practice (GCP) and federal regulations
- Development of an appropriate regulatory and essential documents collection and verification system
- Creation of Manuals of Procedures and other study-related Process Guides
- Oversight and management of Clinical Research Associates - through a Centralized Monitoring system and tightly managed On-site visit assignments, the project management team advises study leadership of problems or potential problems at participating clinical sites identified by the Clinical Research Associates
- Interaction with clinical site study team members - including, but not limited to, advice from first contact with regard to submission of required regulatory documents; continuing assistance throughout the study period for protocol adherence and administration questions; and, creation and distribution of important study-related information
- Management of a communications system between study leadership, study team members and central reviewers
- Involvement with the entire study leadership organization for creation, review, and presentation of study-related material and reports to outside entities
