Clinical Research Associates
The Clinical Research Associate (CRA) is the liaison between the patient, the physician, and the offices that collect and interpret the information provided by research studies known as clinical trials. These trials are designed to answer questions of clinical importance, with the ultimate goal of identifying better methods of cancer treatment. Specially designed case report forms (CRFs) are utilized by the CRA to collect, organize, and submit the information required for any study at specified intervals. The information is reviewed and quality control checks are performed. Any questions or problems are communicated to the CRA. Data are entered into a computer at the Statistical Center after the quality control checks have been completed.
The Clinical Research Associate is proficient in the requirements of the Office for Protection from Research Risks (OPRR). This federal agency, located at the National Institute of Health (NIH), has been given the responsibility, by the Secretary of Health and Human Services (HHS), for administering programs for the protection of human subjects of biomedical and behavioral research. The OPRR is responsible for assuring compliance with the HHS regulations for the protection of human subjects including assessing compliance by awardee institutions.
Each Cooperative Oncology Group (COG) contains its own Institutional Review Board (IRB). This review board contains as many as 20 members composed of medical and non-medical personnel. Any protocol (clinical trial) to be used in the COG must be reviewed and given full board approval before it can be introduced for use on humans. The IRB must be approved by the HHS and must file an assurance with the HHS for both the protection procedures used for human subjects and the IRB. The written proposal assurance must be submitted to the NIH OPRR.
Patients considering participation in a clinical trial are provided with options regarding treatment modalities. At this time the CRA is contacted by the clinician with questions regarding eligibility criteria, and informed consent. The patient's record is carefully reviewed, and if the study requires information such as Quality of Life questionnaires, it may be necessary for the CRA to communicate this to the patient.
The CRA is the assistant to the principal investigator and any responsible investigator introducing studies to be utilized. The investigators are able to provide answers to any questions which may arise before and during clinical management. The goal is to ensure good compliance in order to obtain answers to questions of clinical importance.
The paternalistic approach to treatment should be a thing of the past and patients should be given the knowledge that enables them to make informed decisions. The CRA can be the key as to whether or not a clinical trial is a success.
Connie Snow, CCRA
Diane Gould, CRA