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Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.

Type

Journal article

Journal

Epidemiol Psichiatr Soc

Publication Date

04/2010

Volume

19

Pages

116 - 117

Keywords

Clinical Protocols, Clinical Trials as Topic, Humans