A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice[1] (GCP) under the auspices of a Principal Investigator (PI).
Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [2] as:
Trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).[3]
Benefits outweigh risks for each patient.
Rights, safety and well-being of patients prevail over science.
All available non-clinical and clinical information on any investigational agent can support the trial as designed.
All trials are scientifically sound and clearly described.
All clinical trials have current Institutional Review Board approval.
Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
Everyone involved in the clinical trial is qualified by training, education and experience.
Informed consent is given freely by every participant.
All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
Confidentiality of subjects is respected and protected.
Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
Systems to ensure quality are implemented in all aspects of the trial.
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."[4] The CRC's primary responsibility, as with all clinical research professionals, is the protection of human subjects, but the CRC has many other responsibilities. 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.
^"Good Clinical Practice in FDA-Regulated Clinical Trials". www.fda.gov. Archived from the original on 2001-11-24.
^Ottosen, M. J. (2007). Clinical Research in Clinical Practice, Making it Work for Patients (presentation). The University of Texas Health Science Center at Houston.
^"Home". ich.org.
^Fedor, C.A., et al. (2006 Remedica). Responsible Research A Guide for Coordinators. ISBN 1-901346-68-4
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