Understanding composite and regular datasources

Oracle Site Select supports use of composite (complex and structured) and regular (flat) datasources.

Composite

Composite datasources contain complex, structured data. With composite datasources, Oracle Site Select handles all five composite data entities that comprise a trial-site (sometimes called a study-site):

1. Investigator
2. Institution
3. Trial
4. site
5. trial-site

This means that the Oracle Site Select composite data model imports five unique files: investigator, institution, trial, site, and trial-site that Oracle Site Select combines internally to create a single site row.

Composite datasource benefits:

• Unique institution records combine with investigator records to form sites. Instead of having limited fields to import institution staff records, the investigator file can handle any number of institution staff in a nested structure of: first name, last name, email, phone, and role.
• The investigator file can import any number of investigator email addresses and is not limited to primary and secondary email.
• When creating a master list of sites for evaluation, if the datasource contains composite records, users can additionally filter by: therapeutic area, indication, drug class, and study phase.
• Oracle Site Select calculates an Investigator score for studies involving composite datasources. The score is the average of all site scores for the site's investigator, and it is listed for each of the investigator’s sites.

Note:

Oracle administrators manage composite datasources. Contact your Oracle Project Manager to manage configuration and import of data into these datasources.

Regular

Regular datasources accept data in a flat, CSV (comma separated value) file format, such as an Excel spreadsheet. In this flat data model, each CSV row is a site and that row includes investigator, institution, and site data.

You can configure regular datasources and import data into regular datasources using the Oracle Site Select application. Once you've imported data into a new datasource, contact your Oracle Project Manager who can associate the new datasource to your studies.

Preferred sites: This type of source allows CRO preferred sites to bypass study parameter filters and move into the Master List. This option requires upload and mapping of a CSV format file with CRO preferred sites. The source file must contain a column labeled "preferred_site" and must specify TRUE or FALSE for each row in the source.

Pre-selected sites: You can also upload study-specific, pre-selected site lists and have only those sites included in the datasource displayed on the Master List. To use this functionality, the datasource must include a is_pre_selected_site column, which must specify TRUE for all sites in the datasource.