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...