Developer Features in 23R2

We are pleased to bring you the following additions and enhancements to the EDC & CDB API features in 23R2. REST API features added in 23R2 only affect API v23.2, unless otherwise specified.

Start Job - Study Data Extract

Release Date: June 30, 2023

This API has the following changes:

• The property export_file_types must be used for Study Data Extract versions v23.2 and higher. Previously, the property export_file_type (2 possible choices) was used. The new property is a JSON array of string values, with one to three (in any combination) of CSV, SAS, and XPT
• The property item_display_label can now be used (optional) to specify if SAS labels should use the Item Definition label value, or short label. It is only valid for both an API version v23.2 and use of the SDE version v23.2 (or higher). The default if omitted is the full label.

Start Job - Event Progress Listing

Release Date: June 30, 2023

The property include_review_data can now be used when starting this Job type. When omitted, false is assumed. With a value of true the resulting output will include additional columns regarding review activities in the Events, e.g. SDV/DMR.

Update Subject - New

Release Date: June 30, 2023

This new endpoint is used to perform one or both of these two actions:

• Update the Subject number.
• Update the ixrs_id value (new property that can be set at Create Subject / Casebook)

It can be used against the full study context (Study Country / Site / Subject), or by ID of the Subject.

Retrieve Form / Item Data - Frozen / Locked

Release Date: June 30, 2023

The response for this endpoint now includes the frozen and locked properties at the Item level, not just at Form level. This assists with situations where an integrated data point is locked (or frozen), but the entire Form is not.

Create Subjects (Casebooks) - IXRS ID and EDC URL

Release Date: May 5, 2023

This API has the following changes:

• A new subject property - ixrs_id - can now be set. This value is typically the ID as the IXRS / IRT system knows the subject in that remote system.
  
• For successful creation cases, a relative URL is returned for each Subject. This URL can be used to access the subject at the Data Entry view when combined with the main portion of the Vault URL.

Retrieve Subjects - IXRS ID and EDC URL

Release Date: May 5, 2023

This API has the following changes:

• When set, the new property ixrs_id is returned with the other Subject information.
• A relative URL is returned for each Subject. This URL can be used to access the subject at the Data Entry view when combined with the main portion of the Vault URL.

Set Coding Suggestions - New

Release Date: May 5, 2023

At this release, the API can be used to add suggestions to a Medical Coding Request of a Study. These suggestions will show to the end user of the EDC Coder user interface.

Notes on this feature:

• The vault must have an external suggestion definition (one time, by company) setup.
• Each study that will allow suggestions added to a Medical Coding Request must be activated with that external suggestion definition.
• The suggesting being posted must match a combination from the active dictionary that location is using. (e.g. MedDRA 25.1)

Retrieve Coding Requests - Additional Filters and Suggestions Support

Release Date: May 5, 2023

This API has the following changes:

• New filter coding_status can be used to subset the return Medical Coding Requests. Multiple statuses can be used in one search
• New filter has_coding_suggestions can be used in conjunction with the new coding suggestions feature. Use of this with false will assist an integration on targeting those requests that are in need of suggestions
• New filter inclue_coding_suggestions supplements the full return of information with coding suggestions (external), should any exist

Start Job - Audit Trail (New)

Release Date: February 10, 2023

These EDC job types:

• Audit Trail Export by Study
• Audit Trail Export by Site
• Audit Trail Export by Subject

... can now be used with these API actions:

• Retrieve Study Jobs
• Start Job
• Cancel Job
• Retrieve Job Status
• Retrieve Job Output File
• Retrieve Job Log

CDB Query APIs

Release Date: June 30, 2023

We introduced new endpoints to allow for query management outside of CDB:

• Get Form Data: Provides information about CDB forms that can be used in the new query endpoints.
• Open Query (Items): Opens a query in CDB against item data
• Open Query (Events): Opens a query in CDB against event dates
• Answer Query: Sets a query's status to Answered
• Close Query: Sets a query's status to Closed