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This version has been delayed from the original targeted date of April 4th.

Subject to change up until the release date.

The date indicated here is the expected date of app approval based on Apple review processes and average time-to-approve.

What’s New or Updated

ID

Functional Area

Description

Impact/Risk

Includes Web-service

Web-services Only

276

Subject Records

Toggling between subjects now checks for consent completion if the study is using eConsent

Low

371

Dashboard Report

AE count is now based on variable set in study configuration

Low

X

1627

Role permissions

Added a new host level permission for switching roles at the host level. This will typically only be used by Host Administrators.

Low

X

1626

Trial Master File (eTMF)

Added a 'Task' List for users to see all TMF items they are assigned to

Low

X

1637

Trial Master File (eTMF)

Added option to create placeholders for assigning document uploading tasks to users

Low

X

1504

Trial Master File (eTMF)

Added Version control and blockchain hashing to the TMF audit

Low

X

1498

Trial Master File (eTMF)

Added new properties to TMF files for naming files and tracking workflow

Low

X

1497

Trial Master File (eTMF)

Added file versioning and support for blockchain

Low

X

1510

Trial Master File (eTMF)

Added Workflows and status tracking

Low

X

1656

Inventory Management

Added ability to delete items at the first workflow level

Low

X

Bug Fixes

ID

Functional Area

Description

Impact/Risk

Includes Web- services

Web-services Only

1648

Study Configuration

The mobile app was not enforcing the master permission to “View Subject Event Records”. Only the form-level permission was being enforced.

Low

X

1579

Role permissions

Host level roles could not be deleted from iOS app

Low

X

1654

Conditional Actions

If an external variable was being used to hide only a text label, but nothing else, the label was not hiding

Low

X

1613

Conditional Actions

Populate value CAs based on only an external variable were not always working if subjects existed on multiple cohorts

Low

X

1674

Site and Study Documents

Site and Study log forms were only opening the first record if multiple of one form existed

Low

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