Signatures, randomisation, the casebook and YouEDC Sites as the fourth section

YouEDC Capture

• Investigator e-signature (21 CFR Part 11): the whole patient or each visit, the password at signing, an optional drawn picture, a data change withdraws the signature Investigator electronic signature
• Randomisation: minimisation, stratified blocks, the statistician’s list, a simulator, two signatures, blinding, emergency unblinding, a replay check Randomisation
• eCRF versions: testing, release with a signature, a draft of the next version, comparison, deactivation instead of deletion eCRF versions
• Patient casebook as PDF/A: a certified copy with queries and the audit trail, a zip per site Patient casebook (PDF)
• Medical coding when a form is saved: AEs, history and medications are coded at once, sites do not see codes, the AE code flows to YouEDC Safety and SDTM Medical coding
• The data validation plan (DVP) writes itself from the eCRF builder: UAT test cases, versions, signatures, PDF/A into the TMF DM documents: the DVP and the DMP
• The investigator guide from the eCRF: the patient’s path, forms, checks; the site confirms “I have read it” (training log into the TMF) and prints an A4 card Investigator guide