Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [2] as: The PI is responsible for the conduct of the trial, however, "CRCs are often involved in essential duties that have been traditionally performed by the PI, such as conducting the informed consent process and ensuring compliance with the protocol.
Although not inclusive, some of the CRC responsibilities include preparing the Institutional Review Board submission, writing the informed consent document, working with the institutional official in contract negotiations, developing a detailed cost analysis, negotiating the budget with the Sponsor (i.e., pharmaceutical company or granting agency), subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.
The CTA should include terms for indemnification, confidentiality, publication, intellectual property, insurance, data safety and monitoring boards, subject injury, governing law and termination clauses.
To develop a cost analysis, the CRC reviews the protocol schema and determine which procedures are standard of care, versus research.
The purpose of the case report form (CRF) is to collect relevant data in accordance with the protocol and in compliance with regulatory requirements.
The electronic data capture (EDC) is an online database where the information collected on the Case Report forms (CRF), or source documents is entered.
In addition, the CRC must comply with record retention policies of the Food and Drug Administration (FDA), the ICH, and the clinical trial agreement.