The CRC is a vital link between the research subjects and their family, the investigator, and other site team members. They are also the liaison between the Sponsor, CRO, SMO, Central laboratory, Courier, the Institutional Review Board (IRB), and other players involved in the trial. Because of an increase in the number of clinical trials and the need for complicated and data intensive research, many sponsors today are reluctant to place a trial at a site that does not have a trained CRC to work along with the investigator. The CRC ensures that the potential pool of potential Investigators and Sites keep increasing. The CRC is always on the lookout for new trial sites with Investigators who are research naïve.
This topic describes: General Responsibilities, Capacity Building, Training new CRCs, Trial – related Responsibilities, Site Identification, Pretrial Documentation, Coordinating with the IRB, Financial Responsibilities, Training the Site Staff, Investigators’ Meeting and Site Initiation Visits, Informed Consent Forms, Patient recruitment and follow up, Amendments and Post-trial activities.