
- Applied Clinical Trials-07-01-2007
- Volume 0
- Issue 0
eShowcase: iTrial EDC
Latest iTrial EDC Includes New PDF Generation Tool to Improve Audit Trail Function
Latest iTrial EDC Includes New PDF Generation Tool to Improve Audit Trail Function
Almac Clinical Technologies' (Yardley, PA) latest iTrial EDC release features the newest version of the company's PDF Generation Tool, which is consistent with current FDA eSubmission guidance.
This tool allows sponsors to generate PDFs of their electronic case report forms (eCRFs) for site archival purposes, as well as to complement data submitted for a New Drug Application (NDA).
iTrial EDC allows sponsors to view all data captured with a full audit trail and also to select and view the audit trail for only the data that has changed. The tool includes hyperlink capabilities, which allow users to link to altered fields and associated comments as well as clinical queries.
FDA recently discussed the value of audit trails within eCRFs submitted in PDF format, which sponsors do not typically include.
Almac Clinical Technologies, (267) 685-4284,
Articles in this issue
over 18 years ago
Reach Out to the Peopleover 18 years ago
A Survey of Survivorsover 18 years ago
Will the Real CRO Please Stand Upover 18 years ago
CRA: Jack of All Tradesover 18 years ago
Pediatric Policies Grow Upover 18 years ago
FDA Moves to Update Research Enterpriseover 18 years ago
Recruitment Done Rightover 18 years ago
eShowcase: VISTANewsletter
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