For multi-site studies, a central IRB is permitted under the oversight of local IRB’s. A parallel process of central and local IRB’s is initiated per the client's request. Most principal investigators are independent professional corporations that accept central IRB approvals. However, if the study requires the use of a hospital for services, a local IRB oversight is needed.
DCRC can handle submissions and follow up on IRB applications and approval. The IRB pre-submission process requires three committees to submit initial reports.
The first is the Patient Safety and Ethical committee that confirm compliance with GCP guidelines on patient selection and safety with emphasis on justifications for placebo based studies.
The second committee is the scientific committee that reports on competing studies and the value added by the research project introduced to a patient population.
The third is the operational and financial committee that reviews the budget and its feasibility.