An important facet of the compliance program is getting the investigator to comply with the various official requirements and regulations in order to increase the data credibility of the trial. The common denominator here is the good clinical practice (GCP) document from the European Community (EC), along with an overview of how the European GCP deals with the compliance problem in general: quality assurance (QA) requirements, of which compliance is a part; the investigator's responsibility regarding patient compliance; requirements for the investigator's compliance with regulations; and the role of the authorities.
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SpilkerB. Methods of Assessing and Improving Patient Compliance in Clinical Trials. In: Patient Compliance in Medical Practice and Clinical Trials. CramerJASpilkerB, Eds. New York: Raven Press; 1991:37–56.
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Patient Compliance in Medical Practice and Clinical Trials. CramerJASpilkerB, Eds. New York: Raven Press; 1991.
