Creating Clinical Trial Documentation Packages
Research coordinators compile clinical trial documentation including protocols, consent forms, IRB approvals, and data collection forms. Regulatory agencies require specific formatting, consistent pagination, and tamper-evident documents.
Arbeitsablauf
- Collect all required trial documents from investigators, sponsors, and the IRB
- Convert non-PDF documents to PDF format
- Use the PDF Merger to assemble the trial master file in regulatory-required order
- Use the PDF Page Organizer to add section dividers and a master table of contents
- Use PDF Metadata Editor to add the trial identifier, phase, and sponsor information
- Use PDF Protect to restrict editing while preserving readability
- Submit the documentation package to the regulatory agency
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