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A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents (such as an Investigator's Brochure).
The protocol contains a study plan on which all clinical trials are based. The plan is designed to safeguard the health of the participants as well as answer specific research questions. The protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff (medical doctors and nurses) to monitor their health and to determine the safety and effectiveness of their treatment.
For clinical trials sponsored by pharmaceutical, biotechnology or medical device companies in the United States, European Union, or Japan, the structure and content of a protocol is governed by a regulatory Good clinical practice guidance issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Regulatory authorities in Canada and Australia also follow the ICH guidance.
- ICH Guideline for Good Clinical Practice: Consolidated Guidance
- ICH Guideline for Structure and Content of Clinical Study Reports
- United States National Institutes of Health Glossary of Clinical Trial Terms
Regulatory Agencies Using ICH Guidelines for Clinical Trial Protocol
- United States Food and Drug Administration
- European Medicines Agency
- Japanese Ministry of Health, Labour and Welfare
- Health Canada
- Australian Therapeutic Goods Administration
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