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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
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.
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.
5 This template is intended for interventional clinical trials of drugs, vaccines, and drug/device 6 combinations intended to be registered as drugs. The template is suitable for all phases of 7 clinical research and all therapeutic areas. Existing ICH Guidelines and ISO 14155 were 8 considered in its development.
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.
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).
