Agatha Archives

Electronic Trial Master File (eTMF)

Electronic Trial Master File (eTMF)The Trial Master File is a structured set of files used by sponsors and CROs to demonstrate proof of regulatory and ethical requirements for conducting clinical trials. It includes documentation of the following items:* Regulatory...

Electronic Submissions Gateway (ESG)

Electronic Submissions Gateway (ESG)The Food and Drug Administra­tion’s Electronic Submissions Gateway (the ESG) is an agency-wide solution for accepting regulatory submissions from regulated entities. It allows companies to securely submit their premarket and...

Electronic Signature

Electronic SignatureAn electronic signature is a compilation of any kind of signa­ture (symbols) executed, adopted, or approved by an indi­vidual to be the legally binding equiva­lent of his/her handwritten signature. Signatures,Electronic signatures,documents,digital...

Electronic Data Capture (EDC)

Electronic Data Capture (EDC)A system capturing patient case report form information. Time,trial,clinical trials,forms,studies,integration,Electronic Data Capture,process,features,query,electronic case report forms. Application,regulatory compliance,contract research...

Drug Product (DP)

Drug Product (DP)A finished dosage formulation containing a drug substance (e.g., tablets, capsules, solutions) Drug,processes,development,control,drug product,drug substance,condition,disease. Drug Product (DP,issues,study,submission,devices,Primary...