Review CRF – Case Report Form

The Case Report Form (CRF) is the main tool to collect data in the clinical study. It can take many forms: from a paper CRF to be completed by hand with a ballpoint, to an electronic web-based set of entry screens where the site can enter test results. Also subject diaries or subject questionnaires are frequently used data collection tools. Sometimes one uses terms like eDC (electronic Data Capture) or eCOA (electronic Clinical Outcomes Assessments). All these are related to collecting results and having them stored in one central database. It is highly important that the statistician reviews all data collection tools, to ensure that the collected data are relevant and will enable to perform the planned statistical analyses and testing. The Emtex statistician has over 25 years of experience and will be happy to support.

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We would like to thank you thoroughly and emphasize that we very much appreciated your review. Both we and the sponsor have repeatedly stressed during the meetings that your review has been a great value to the quality of our documents. Thank you for this collaboration!

Clinical Research Associate

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