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 MTCDEpi Initial Case Report Form062012 DOCX LCP RELEASE of INFORMATION Dphhs Mt 2012

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before we go into the roles and responsibilities let's review what we mean by case report form ing to ISO 14 155 a case report form or CRF is defined as a set of printed paper or electronic documents designed to record all information necessary about a subject that has been enrolled in the clinical investigation what information is to be recorded is dictated by the requirements of the clinical investigation plan now there are specific rules for completing case report forms and we will review some of the essential ones here the investigator can delegate the completion of case report forms to another physician study coordinator nurse or assistant only if these authorized designee x' have been trained properly on the process and if they have the necessary clinical qualifications only the principal investigator or his or her authorized designate with qualifications equal to the principal investigator can sign off on the case report forms whether paper or electronic signature before signing

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