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Protocol Development in Clinical Trials for Healthcare Management

Protocol Development in Clinical Trials for Healthcare Management

Swati Changdeo Jagdale, Asawaree Anand Hable, Anuruddha R. Chabukswar
Copyright: © 2021 |Pages: 18
ISBN13: 9781799834793|ISBN10: 1799834794|EISBN13: 9781799834809
DOI: 10.4018/978-1-7998-3479-3.ch124
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MLA

Jagdale, Swati Changdeo, et al. "Protocol Development in Clinical Trials for Healthcare Management." Encyclopedia of Information Science and Technology, Fifth Edition, edited by Mehdi Khosrow-Pour D.B.A., IGI Global, 2021, pp. 1797-1814. https://doi.org/10.4018/978-1-7998-3479-3.ch124

APA

Jagdale, S. C., Hable, A. A., & Chabukswar, A. R. (2021). Protocol Development in Clinical Trials for Healthcare Management. In M. Khosrow-Pour D.B.A. (Ed.), Encyclopedia of Information Science and Technology, Fifth Edition (pp. 1797-1814). IGI Global. https://doi.org/10.4018/978-1-7998-3479-3.ch124

Chicago

Jagdale, Swati Changdeo, Asawaree Anand Hable, and Anuruddha R. Chabukswar. "Protocol Development in Clinical Trials for Healthcare Management." In Encyclopedia of Information Science and Technology, Fifth Edition, edited by Mehdi Khosrow-Pour D.B.A., 1797-1814. Hershey, PA: IGI Global, 2021. https://doi.org/10.4018/978-1-7998-3479-3.ch124

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Abstract

Clinical trial is a part of clinical research. It is a systematic experimental biomedical study. They are carried out to evaluate the effectiveness and safety of medications or medical devices or biologics. Trials are conducted to check safety and efficacy of new drug. It includes four phases as phase I, II, III, and IV. The study is carried out according to study protocol and standard operating procedures as per good clinical practices guidelines. The study protocol is developed by the researchers and approved by an independent committee called as Institutional Review Board. Protocol is a roadmap for team of healthcare professionals involved in investigation work. It should explain the significance of research trial, location, detail procedure, methods, activities, time allotment, financial estimate and any other information required. The content of protocol are title, objective, background, eligibility criteria, study methodology, risks or adverse effects, benefits, alternative treatment, data collection, statistical treatment, regulatory guidance, and other information.

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