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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
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
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.
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.
This Clinical Study Report (CSR) Template is specifically designed to be used in conjunction with the Clinical Study Protocol (CSP) Template. The structure and sections as well as their order and content follow the International Council for Harmonisation (ICH) E3 guidelines for CSRs, as recommended by the Food and Drug Administration (FDA).
5.1.1 Case Report Forms (CRFs) are the usual data collection tool used in a clinical trial and are essential for quality assurance and control. The CRFs can be either in paper format (pCRF) or an electronic CRF (eCRF). The procedures outlined below apply to both CRF formats.
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
