Business Operations Policy
It is the policy of GW/GW MFA that no clinical research study may begin at this institution until a fully executed Clinical Trial Agreement (CTA) and final, mutually agreed-upon budget are in place. This requirement applies to all industry-sponsored and externally funded clinical trials and ensures that legal, financial, regulatory, and operational obligations are clearly defined and accepted by all parties before study initiation. Execution of the CTA and approval of the final budget must be completed prior to any research activities, including subject recruitment, screening, data collection, or access to investigational product. Failure to comply with this requirement will delay study activation and may result in suspension of study start-up processes.
This policy acts in tandem with the Clinical Research Compliance Policy.
Business Operations SOPs
- SOP 1: Study Contract Intake Process
- SOP 2: Contract Timelines
- SOP 3: Budget Timelines