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Annexure 6 MDR Form Primary Informer DOC Cghealth Nic

Annexure 6 MDR Form Primary Informer DOC Cghealth Nic

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[Music] welcome back to the gcp mindset channel as you may know from our previous video the essential documents of each clinical study are the study protocol the investigator's brochure and the case report form today we will take a closer look on the case report form more after the intro [Music] the third important study document is the case report form crf if you haven't already watch our videos about the study protocol and the investigators brochure first you can find them above watch them then let's go on with the case report form the crf serves to document all relevant data ing to the protocol and is an informational medium by which study data can be transmitted from the trial site to the data management crf exists in paper form sometimes even on carbon paper as well as in electronic form one crf is filled in per patient crf need to be allocated to patients clearly in order to avoid confusion the case report form is usually divided into five modules with thematically related conten

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