Joint meeting of Good-clinical-practice compliance Inspectors Working Group and eClinical Forum representatives on electronic data capture systems and investigator site eSource readiness
EventCorporateCompliance and inspections
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The meeting was organised to clarify the requirements expressed by the EMA GCP IWG with regards to electronic data capture systems used in clinical trials in order to ensure that industry is in line with those expectations. The eCF eSource sub-team representatives received feedback on the eClinical Forum's Investigator Site eSource-Readiness Assessment Project and present the document and tool they have developed.