THE DCRI AT A GLANCE
The Department of Clinical Research and Innovation (DCRI) was created in 1998 with purpose of ensuring compliance with Good Clinical Practice (GCP) according to the International Conference for Harmonization (ICH) and to provide enhanced quality of clinical research data.
The DRCI provides regulatory, administrative and educational services to the Institute’s investigators or staff participating in multi center, national and international clinical trials. This resource also serves to increase awareness and accrual to clinical trials as well as to improve the quality and efficiency of conducting clinical trials in compliance with regulatory, documentation, and oversight requirements.
The main goals of the service are: the application of the strategy provided by the IPC Strategic Orientation Committee (Comite d’Orientation Strategique, COS) in clinical research evaluation, the sponsoring of multicenter clinical trials coordinate by IPC’s physicians and providing data management and statistical expertise, registration of databases for specific cancers (breast, prostate, colo-rectum, leukemia, lymphoma…) and graft procedures.
Project leaders. In close relation to the medical coordinator of the clinical trial, they write the trial protocol, record patients inclusions, control all stages of the test, from its initiation to the analysis and publication of results, and supervise the administrative and financial aspects of the study.
A pharmacist prepares prescribed treatments in the trials.
Technicians and clinical research nurses provide the day to day running of the tests with all involved.
Finally, the Data Processing Centre, the head of data management (data manager) sets up a database for every test in conjunction with the medical coordinator of the test. It provides logistical support to data collection and quality control in strict compliance with good clinical practice. Finally it provides actionable data to biostatisticians for their analysis with the medical coordinator of the project.