RAYLYTIC_UNITY_Real-time reporting_EDC System

WHAT'S NEW?

UNITY UPDATES & NEW FEATURES

NEW (Release 9.3.0)

Cross Form Validation – Update

Many questionnaires ask for similar or related information. However, patients, clinicians and clinical staff may answer inconsistently, which reflects in the collected data.

UNITY can now be configured to automatically compare and validate answers provided within questionnaires as well as across different questionnaires. By automatically detecting inconsistent answers, high data quality is ensured, while error-prone and time-consuming cross-checks are avoided.

Validation

PREVIOUS UPDATES

20211125_Cases-1

Cases (Release 9.2.0)

A patient may be receiving more than one clinical intervention, even within a clinical trial. To correctly document and track multiple interventions per patient, we are introducing the concept of “cases”.

A case is defined by a treated organ, joint or other anatomical region and depends on the configuration additional to the treatment (e.g., date of surgery, type of treatment). This can be adjusted to match the definition of medical registries for tracking e.g., the lifetime of medical implants.

UNITY distinguishes between site ID (01, 02, 03, …), patient ID (001, 002, 003, …) and case ID (1, 2, 3, …). When a site (e.g., site 05) registers a patient, the patient ID (e.g., 008) and a case ID (e.g., 1) can automatically be assigned in sequential mode, resulting in a combined ID per patient (e.g., 05-008-1).

Data Queries & Remote Monitoring (Release 9.1.0)

When reviewing data entered in UNITY, data monitors may identify mistakes, inconsistencies or abnormalities. UNITY now facilitates the tracking of data queries and their resolution. Users are now able to comment, revise, correct and approve a specific data entry. Different labels identify the status of a query as “open”, “answered” or “resolved”, prompting action by the responsible staff.

By tracking queries exactly where data is collected and reviewed, UNITY ensures that the complete history of any data entry, the process resulting in corrections, reviews and approvals, is captured and reportable for compliance to regulatory requirements. Source documents uploaded in UNITY allow for effective remote monitoring with substantially reduced cost.

Query

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