View and filter applications:

A full record of submitted applications can be viewed in the Case Management tab. This includes study details, sponsor contact, study and application status, submission date, patient identifier, and research site contact.

Applications can be filtered by:

• Application status.
• Sponsor contact.
• protocol title.
• Clinical trial status.
• Compassionate use status.

Details of an application can be viewed by:

1. Navigating to the Case Management tab.
2. Clicking on “View details” in the action’s column of the case management list. The user will then be presented with an application summary including study information, sponsor and site information, with related links to each section.

Another navigation panel will allow the user to review the details of the application made including:

• Study identification.
• Research site and eligible physician information.
• A clinical summary of the case, including:
  • Subject medical conditions.
  • Laboratory results.
• Eligibility criteria met for the study.
• Whether additional patients can be identified for the study at the applicant site.
• IRB/IEC credentials; and Study coordinator, pharmacy contact and other application contact information.

Edit application:

Once submitted, applications cannot be edited unless the sponsor requests additional information. At that point, the application form can be updated and re-submitted as requested.

Withdraw application: 

After submission, any member of the research site team can withdraw an application by opening the application details and selecting “Withdraw application” from the dashboard menu.

View application history:
Access a full record of an application’s activity by selecting “View application history” in the study detail dashboard.

View application documentation:

Study-related documents can be viewed via “View study documents” in the application detail dashboard.

• Access is granted only after a confidentiality agreement has been uploaded.
• The document library follows the TMF Reference Model and may include protocols, investigator brochures, consent forms, regulatory approvals, investigator CVs, agreements, IP handling documents, and other study-related materials.

Research site users can upload documents directly to the application record from the application details section. Study documents are only accessible once an application is approved and a confidentiality agreement is in place.

Patient management 

The ‘Patients’ tab allows site administrators and staff to manage all registered patients.

• Patients are listed alphabetically, with filters for date of birth, gender, diagnosis, and location.
• New patients are added through the Demographics form, which checks for existing records before manual entry.
• Each profile includes a Patient Card with key demographic and clinical data, plus tabs for forms such as Clinical Events, Vital Signs, and Medications.
• Users can edit profiles, manage applications, or remove patients (if no active/approved applications exist). Blocked patients remain viewable but cannot be used for new applications unless prior ones are approved.
• Patient profiles are added under this tab during the application process, using deidentified patient information to populate a patient’s profile.