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Gather relevant reference documents (e.g., protocol, CRF reference library, Statistical Analysis Plan (SAP), data requirements from Sponsor or regulatory agency, review standards (C-DASH, PhenX), most recent
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.
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
1 Οκτ 2014 · Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data.
A Case Report Form (CRF), according to the ICH GCP guidelines, is a ‘printed, optical, or electronic document designed to record all the protocol required information to be reported to the sponsor on each trial subject.’ ICH GCP section 1.11 In some cases, the CRF may be the source document, for example for a study where a
Definitions Case Report Form (CRF) Form on which individual participant data required by the study protocol are recorded. It may be a paper document or a computer application, commonly a web-based portal system, where site staff enter data into an electronic case report form (eCRF).
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.
