Clinical Study Protocol Document
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A Clinical Study Protocol Document is a research study protocol document for a clinical study.
- Context:
- It can range from being a Clinical Trial Protocol Document to being a Observational Clinical Study Protocol Document.
- It can (typically) describe the objectives, design, methodology, and statistical considerations related to the resulting clinical study data.
- It can be produced by a Clinical Study Protocol Development Task (supported by a clinical study protocol development system).
- It can associated to a Clinical Study Protocol Template.
- It can (often) contain a:
- Clinical Study Title Page.
- Clinical Study Background Information Section.
- Clinical Study Objectives/Purpose Section.
- Clinical Study Study Design Section.
- Clinical Study Statistics Section.
- Clinical Study Data Handling and Recordkeeping Section / Clinical Study Data Integrity Section.
- Clinical Study Project Timetable/Flowchart Section.
- Clinical Study References Section.
- Clinical Study Supplements/Appendices Section.
- …
- It can be associated with a Clinical Study Publication.
- It can be associated with a Clinical Study Protocol Amendment.
- …
- Example(s):
- Trial Protocol: DS8500-A-U202 “A Randomized, Double-Blind, Placebo-Controlled with Active Comparator, 12-Week Study of DS-8500a in Subjects with Type 2 Diabetes Mellitus on Metformin"[1].
- Trial Protocol: NCT04020341 [2].
- …
- Counter-Example(s):
- See: Research Project Specification.
References
2013
- (Hulley et al., 2013) ⇒ Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, and Thomas B. Newman. (2013). “Designing Clinical Research: Fourth Edition.” Wolters Kluwer Health. ISBN: 9781469840543
- QUOTE: Protocol: The detailed written plan for a study. For example, the study protocol for a study specified that only subjects who could understand English at the eighth grade level were eligible for participation.