Types of PDFs
You determine the PDF type on the Study Information page when you create a new PDF request.
These PDF request types include a lot of predefined settings:
- Submission PDFs—PDFs generated from an InForm study that will be used in submissions to regulatory authorities for drug or device approval. Typically, these requests include a subset of study subjects.
- Archival PDFs—PDFs generated from an InForm study that form the permanent record of the study and are available for review after the study database has been locked or decommissioned. Typically, these requests include all sites and subjects. Sometimes only subjects of a closed site are generated.
- Blank Forms Only PDFs—PDFs that describe the forms, including the set of potential answers for each form item. No subject data is included.
These PDF request types give you complete control over all settings:
- Custom PDFs—PDFs based on settings provided by a sponsor user to create customized clinical and blank PDFs.
- Custom Blank Forms PDFs—PDFs based on settings provided by a sponsor user that include blank forms only (no clinical data).
Copyright © 2016 Oracle and/or its affiliates. All rights reserved.