Template to add a clinical trial: Difference between revisions
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==Overview of | ==Overview of Trial== | ||
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Revision as of 12:11, 18 May 2009
How to edit trial information: Log in, click on the word [edit] to the right of the section you would like to edit, type in the appropriate information, click save page at the bottom when you are done. The template is the minimum elements required by the World Health Organization. You can add additional sections.
Complete Title of Study
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Study Acronym (The trial's abbreviation if there is one)
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Principal Investigator, Co-investigators, and Collaborating Institutions
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Overview of Trial
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Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
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Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
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Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
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Study Arms and How They Were Treated (Intervention) (Explanation here)
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Primary Pre-Specified Endpoint
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Secondary Endpoints
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Inclusion Criteria
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Exclusion Criteria
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Ages
__ years to ___ years
Gender (Indicate whether men, women or both were enrolled)
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Accepts Healthy Volunteers (Answer yes or no)
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Enrollment Period (Study start and end date)
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Recruitment Status (explanation)
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Enrollment (Total number of patients enrolled)
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Study Sponsor (e.g. Investigator initiated or company name)
None reported (this may not have yet been ascertained)
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
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Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
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Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
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Medline PMIDs
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External sites for further information (How to insert links)
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References (How to insert a reference)
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