Titlebook: Conducting Clinical Trials; Frank L. Iber,W. Anthony Riley,Patricia J. Murray Book 1987 Plenum Publishing Corporation 1987 clinical resear

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Introductionis introductory chapter will trace the development of the ethical and regulatory concepts that have influenced and controlled current research practices to provide a framework that the new investigator or research administrator may find useful in interpreting this work.

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Staff Selection and Trainingy existing personnel or will require the recruitment of new employees. The PI must also decide whether he is prepared for extensive training of new personnel or wishes to hire highly skilled employees with some research experience. Inexperienced PIs are advised to employ those with specific drugtesting experience.

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Special Populationsson must be able to assimilate the study information and consent to participation. (2) The person must be able to give consent legally. Various levels of interference with one or the other of these key conditions are presented in Table 19.

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Informed Consent: Decision amid Uncertainty medicolegal requirement but also to use the uncertainty of the research process as a basis for developing mutual trust and an alliance with the patient. This working together in dealing with the uncertainty of the research is the first step in bringing the patient into the research team (i.e., having the patient give his consent to participate).

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Compliance of Patients Currently on Studyuired diaries is an undeniable matter of record. Whether the medication dispensed is taken or used is not so easily established. This section considers ways of enhancing patients’ medication taking and visit compliance.

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