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Writing the core of your case report: clinical findings and outcome Step 1: state the obvious Start by asking yourself: What are we talking about? Whom are we talking about? Why is this observation important? Who needs to know about this case? Example
Case Report Form (CRF) A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial
Welcome to Global Health Trials' tools and templates library. Please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. Please click on the orange text to download each template.
As such, this CSR Template is the foundation for an “integrated” full report of any study with a therapeutic, prophylactic, or diagnostic agent (i.e., drug or treatment) conducted in patients or healthy volunteers.
1.2 The case report form (CRF) is a data collection tool used to capture the required data, as defined by the protocol, for each individual subject during their participation in the trial.
US Clinical Development& Medical Affairs-General Medicine AIN457/Secukinumab Clinical Trial Protocol CAIN457FUS01 / NCT02798211 A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of secukinumab 300 mg and 150 mg in adult patients with
To describe the procedure for development and design of Case Report Forms. 4. Scope This SOP describes the procedure for development and design of Case Report Forms (CRFs) used in clinical trials sponsored by NNUH. ICH GCP E6/SI 2004/1031 DocuSign Envelope ID: 900E6F35-29F7-4979-8CE6-6241173CA302
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