CLINICAL TRIALS PROGRAM
The Clinical Trials Office was instituted to enhance the ability of the physician staff to carry out industry-sponsored clinical studies. The Clinical Trials Office function is to assist any physician in the conduct of clinical trials including
- Initial contact with industry sponsors
- Protocol development
- Regulatory document preparation and filing
- Budget preparation
- Investigators and staff training of the GCP guidelines
The goal of the clinical trials program is to conduct clinical trials of the highest quality standard. The program is staffed with dedicated registered nurses, who work with physicians, pharmacists and hospital staff to ensure accuracy in the conduct of clinical trials. This networking also makes it possible to gain referrals for studies. The program was initiated to:
- Increase the number and quality of clinical trials ongoing
- Assist departments that otherwise could not carry on clinical research
- Increase the capabilities of departments already staffed with research personnel to do additional trials.
The staff of the clinical trials program is available at a standard hourly fee to assist investigators in all aspects of the conduct of a trial from IRB submission through end of study audits. The clinical trials program is currently involved in 30 active clinical trials and has conducted over 60 trials since its inception.
In order for monitors to view EPIC medical records, they need to have special access granted by LUMC IT.