Training Clinical Trial Agreements

For example, consider whether ancillary agreements with site management organizations should be covered by the primary agreement for clinical trials. Write the procedure clearly and concisely so that everyone, including a new collaborator, can make sense of it and accomplish the tasks related to it. Sponsored Projects (SP) is responsible for the audit, negotiation and legal implementation of external funding agreements. The resolution of many contractual issues requires coordination between the external funding source, the investigator and the SP; the involvement of each of the parties is essential for the contractual agreement to be successfully concluded under mutually acceptable conditions. Principal Investigators should discuss all aspects of the clinical trial prior to the start of negotiations with their contract manager. Pharmaceutical or medical device companies, clinical research organizations) include human testing activities related to an investigational drug, compound or product leading to the Food and Drug Administration`s authorization for commercial distribution. Auditors should provide PS with a copy of the draft Clinical Trials Agreement (ATA), protocol and a company contact person as soon as possible. If there is already a framework contract between the sponsor and the University of California, the negotiation process is usually accelerated. The IRB`s agreement is not required to submit the proposal to PS and enter into contractual negotiations. Bob Romanchuk is a clinical research expert with over a decade of experience in a wide range of clinical research infrastructures, the operation and management of BRI and research programs…