Caregiver Support

With this feature, patient caregivers are able to complete assigned surveys and sign consent forms.

• ePRO: When enabling a participant for ePRO, site users can select an existing guardian, proxy, or caregiver for a patient or create a new one if none exist.
• eConsent: The Caregiver role is an option for Role selection fields when creating a signatory, sending an eConsent, or using the eConsent Editor. When consenting, caregivers can only sign signature blocks assigned to the Caregiver role; they cannot sign or answer questions in place of other signatories.

Site eBinder

This feature introduces a central location to manage site operational documents not associated with a study. Using the familiar structure and navigation of the Study eBinder, users can upload, access, approve, and initiate workflows on site documents. Non-study-specific documents filed in the Study eBinder, such as those in the Staff and Partner Organizations folders, are accessible from either eBinder.

Site Documents appear in the following eBinder folder structure:

• SOPs & Policies
  • Policy Memo
  • Standard Operating Procedure
  • Work Instruction
• Staff
  • Curriculum Vitae (CV)
  • Medical License
  • Signature and Initials
  • Training Evidence (non-study-specific)
• Partner Organizations
  • IRbs/IECs
  • IRB/IEC Compliance
  • IRB/IEC Composition
• Labs
  • Lab Certification
  • Lab Director Qualifications
  • Lab Normal Ranges

Study Team Assignments: Copy and Bulk Create

This feature enables Site Administrators to create study team assignments in bulk or to copy assignments from an existing study. The +Assign button prompts a dialogue to select one or multiple users to assign in a single process. The dialogue also includes the option to copy assignments from an existing study. This action populates the dialogue with the assignments of the existing study and then remains active for any needed adjustments. Additional enhancements to the Study > Study Team Assignments section include the ability to filter by Role or Assignment Status and to edit statuses directly in the Assignment Status column.

Upload and Start Workflow

This feature expands the current upload functionality to include the ability to initiate a workflow when uploading to the Study eBinder or Site eBinder. Users can initiate eSignature, Read and Understand, and Review workflows without opening each document after upload.