InForm users at sponsor organizations and sites use the CRF Submit application to generate and retrieve PDFs and History reports for a given study.
Sponsor users are typically CRAs, CDMs, CROs, and medical monitors, who review clinical data queries, perform source verification, transfer subjects from one site to another, run standard reports, and create ad hoc reports.
Sponsor users generate PDF output using several request types. Sponsor users with the Share with Sites right can share archival PDF output with sites for download and generate the PDF for a particular rights group. As in InForm, specific rights groups may see different items in the study. Sponsor users with the right to view the Site Confirmation report can monitor site actions related to shared archival PDFs. Sponsor users can also request Subject Audit History and User Assignment History reports based on site data and share these with sites.
Site users are typically CRCs or PIs, who register subjects into a study, enter and change clinical data in electronic case report forms, answer queries on clinical data, sign electronic case report forms, and prepare for monitoring visits.
Site users can generate PDFs for their subjects at their sites only, without relying on the sponsor user to provide this output. PDF request settings for site users are limited to the options most applicable to site users. The information included in the PDF file always matches what the user sees in the InForm application. Site users with the site confirmation right can signify that they have downloaded the archival PDFs and History reports that a sponsor has shared.
In addition to CRF Submit permissions, some CRF Submit users have authority to perform administrative functions, such as assigning CRF Submit rights to InForm rights groups.
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