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Reflection Paper Expectations Electronic Source Data Data ...
At each stage of the electronic data capture and handling in the clinical trial database, the responsibilities of the investigator and the sponsor as defined in GCP should be applied, in order to ensure the reliability of the data. The use of electronic records for clinical data results in new issues as well as a need to reiterate
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Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification
Guideline for good clinical practice E6(R2)
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Guideline on good pharmacovigilance practices …
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cdn.pfizer.comEnsuring quality data. The Clinical Study Report (CSR) is the report that summarizes the clinical data. It includes the entire protocol, sample case report forms, investigator information, all information related to the investigational product being studied as well as any statistical analyses, publications, tables or other data. It is an integrated