Data Intake integration

There are two types of data intake integrations available through the Oracle Clinical One Digital Gateway that can be utilized to load data into forms in Oracle Clinical One Platform.

Configuration Service details for these integrations

B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Note:

For more information see, Oracle Life Sciences Cloud Consulting Professional Services, Service Descriptions and Metrics.

Reach out to your Oracle point of contact if more information is needed.

CDISC Lab Data Intake

Load lab data into Oracle Clinical One Platform that adheres to the Clinical Data Interchange Standards Consortium (CDISC) Laboratory Data Model (LAB) standard, ensuring the data being loaded is done so in accordance with the industry's standard for transmitting electronic data related to drug development.

Data for this integration can be loaded into flat, repeating and multi-section forms assigned to a scheduled visit, unscheduled visit or cycle visit.

Note:

Data loaded into hidden items does not adhere to the CDISC LAB standard.

Generic Data Intake

Load generic data such as subject and questionnaire data into Oracle Clinical One Platform forms.

Data for this integration can be loaded into flat and repeating forms assigned to a scheduled visit, unscheduled visit or cycle visit.

Data Intake integration overview

• Forms are created during study design that are to be populated through a data intake integration.
• The integration is configured using the integration template.
• Data files (ASCII .txt comma or pipe delimited), are placed on the Oracle sFTP server by the vendor which are picked up once detected by the Oracle Clinical One Digital Gateway.
• The Oracle Clinical One Digital Gateway validates and incrementally processes the file, then uploads the data into the appropriate forms.
• Queries are automatically raised as per the rules that have been predefined in the study design.

Data Intake integration error handling

• If data does not conform to the expected format defined for an integration or if data points do not match the options defined in Oracle Clinical One Platform such as study name, visit, form, or subject id the job will fail and displays the appropriate error message and remediation details.
• If a Data Intake integration attempts to populate a form in a skipped visit, a visit manually skipped by a user, the import job fails, and data does not integrate. To resolve this, a user must undo the skipped visit followed by the vendor placing the file on sFTP for re-import.
• Scheduled visits can be loaded out-of-order except for branch visits. Integration jobs will fail if sending data out-of-order for any branch visit (non-cycled and cycled). For example, if a branch has Day1 -> Day2 visits then the Day2 visit cannot be loaded before Day1 is completed.