The Role of the Clinical Research Coordinator
"First do no harm" is the golden rule for health care providers, and the number one priority in a clinical trial using human subjects to test the safety and efficacy of an experimental drug or biological product. The clinical research coordinator (CRC) is part of a team that includes a clinical research associate (CRA), a principal investigator (PI), and a clinical trial monitor, and may include others. The CRC secures a site for the clinical trial, recruits study participants, ensures proper storage and dispensation of study drugs and supplies, and ensures the accuracy of all documentation. The CRC's most important job, however, is to ensure that the clinical trial is conducted in adherence with Good Clinical Practice (GCP) guidelines, as mandated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). GCPs were adapted by the ICH in order to protect the welfare and the privacy of human subjects who participate in clinical trials.
GCPs ensure that (1) the benefits to trial subjects and to society can be justified against potential risks, (2) the rights, safety, and well-being of clinical trial participants take priority over the benefits to science and the public, (3) data on an experimental drug or biological product supports the proposed clinical trial, (4) the clinical trial is supported by sound scientific principles, (5) the clinical trial complies with its institutional review board (IRB) approved protocol, (6) study participants remain under the care of a qualified health care provider throughout the duration of the trial, (7) each member of the clinical trial team meets training and educational requirements, (8) all clinical trial participants provide informed consent, (9) clinical trial data is recorded and reported accurately and that it can be verified, (10) the privacy of participants' medical information is respected, (11) investigational drugs and biological products are manufactured and stored in accordance with good manufacturing practices (GMP).
A CRC can wear many hats. The CRC plays an important role in screening of potential study subjects, ensuring that participants meet inclusion criteria for the clinical trial. Once a participant has been accepted into the clinical trial the CRC can initiate the informed consent process. An informed consent explains the purpose and goals of the study, its duration, and describes the protocol to be followed. It describes any risks to the participants, as well as benefits, and informs them of any alternative procedures they may wish to explore. Participants are advised that their medical information will be kept confidential, and that medical care is available to them in the case of an adverse reaction during the clinical trial. Most important, the informed consent advises patients that their participation is voluntary and that they can withdraw from the clinical trial at any time. The CRC coordinates patient care schedules and assures adherence to the clinical trial protocol. It is the CRC's responsibility to alert the PI and sponsor of any serious adverse events reported by patients during the course of the study.
Before a clinical trial can begin it must be approved by an IRB. Both the trial sponsor and the IRB will have certain requirements and stipulations. The CRC is a liaison between the IRB and the sponsor. The CRC also coordinates negotiations between the sponsor, the PI, and the study site for the clinical trial agreement (CTA). Issues covered in these negotiations include confidentiality of information, publication of data, intellectual property, insurance, data safety and monitoring, harm to subjects, governing law, and termination clauses.
The CRC develops a budget for the study that covers the cost of research, pharmaceuticals or biological products, study personnel, study site, travel, equipment and supplies, and IRB fees. The CRC collects data and other information relevant to the trial on a case report form (CRF), in accordance with clinical trial protocol and with all regulatory compliance requirements. The CRC submits the CRF to the trial sponsor on paper or in electronic format. When the trial comes to a close, the CRC will complete appropriate documentation, and will see to it that records are retained in compliance with Food and Drug Administration (FDA) and ICH policies.
A successful clinical trial is the result of a thoughtful collaboration between sponsor, PI, study site coordinators, and the local IRB. Preparation for a clinical trial is a serious business, often requiring delicate negotiations, and attention to complex issues, along with a million small details. The CRC is at the center of it all, and embodies the true essence of ethical clinical conduct by ensuring that the clinical trial operates in compliance with GCPs and any other national and international regulatory standards. The CRC is the guardian and the gatekeeper, entrusted with protecting the rights, privacy, and well-being of human clinical trial subjects.
