Mapping and importing regular datasources

Oracle Site Select users who have permission to access the Data source management page have the ability to create, import, and publish one or more study data sets.

If you have the data source manager role in Oracle Site Select, you will have access to the Data source management page.

Create a new regular datasource

Create a new datasource for any dataset that you want to import and merge into the Oracle Site Select site profile database. You will determine the unique identifier for the datasource and set up definitions for each field in the datasource.

Clone an existing datasource definition

On the Manage data source definition page, the Clone datasource option copies an existing datasource schema and reloads the page to display the copy with "_copy" appended to the name. On the copy, change the name and description as preferred.

The copying process does not replicate the data or sites in the original datasource; however, for flat/regular datasources, the datasource copy includes the data structure CSV file from the original datasource. You can overwrite the file with a new CSV and modify fields and field mappings in the copy as preferred.

Publish a regular datasource

Once data definition is complete, you can publish the datasource to your account in Oracle Site Select. The datasource will be private to your account.

Import to a regular datasource

For any published datasource in your account, you can import data in CSV format.

Discontinued records

Oracle Site Select users who manage datasources can upload a source that includes records flagged as “discontinued” at the institution, investigator, or site levels. When flagged as discontinued, Oracle Site Select filters all sites correlated to the institution/investigator/site/trial-site from master list generation, except as described below.

When multiple datasources exist for a study, datasource priority as well as record updates (e.g., changing a discontinued setting from “true” to “false”) may affect the display of a discontinued site in the master list/nominate bucket. The following list details expected behaviors for this feature:
  • A site currently in the nominate bucket that later has the discontinue flag set to true remains in the nominate bucket unless another action, such as changing the priority of study datasources, triggers the rebuild of the master list.
  • If the discontinue flag for the institution/investigator/site record is false and the site is nominated and moved beyond the nominate bucket, and later the discontinue flag is updated to true, Oracle Site Select will maintain the site record in the site grid and preserve the underlying data that contributes to the site record from the originating datasources (regardless of site profile record). In this case the site's investigator name will be formatted in maroon text with an accompanying alert icon (Icon is a lower case letter "i" inside a maroon triangle) displays in the grid.

    Note:

    A site profile record that shares a master profile ID with an institution/investigator/site will be filtered based on the criteria above only when a datasource with the discontinue flag set to true is attached to the study.
  • The master list will not automatically regenerate if an attached datasource has the institution/investigator/site discontinue flag set to true and the flag is later updated to false. However, if an Oracle Site Select user triggers master list regeneration (e.g., by changing the priority of study datasources) the site will be filtered according to the expected behavior described above.
  • When two datasources are attached to a study and the higher priority datasource has the discontinue flag set to true, the site is filtered from nomination/master list along with any associated site profile record. However, when two datasources are attached to a study and the higher priority datasource has the discontinue flag set to false, but the lower priority datasource has the flag set to true, the site/site profile record is not filtered from nomination/master list.
  • A site record with preferred and/or preselected site set to true and discontinue set to true will be included in the master list provided the preferred site and/or preselected site check box setting is enabled on the study parameters page. The record from the CSV where preferred_site=true and/or preselected_site=true will be the record that persists. Again, in this case, the site's investigator name will be formatted in maroon text with an accompanying alert icon (Icon is a lower case letter "i" inside a maroon triangle) displays in the grid.

These records provide hover over tool tip text and display the discontinue reason, if available. Users can also optionally include an institution/investigator/site discontinue reason column in the grid, if preferred.

Institution country name validation

Upon import, Oracle Site Select validates institution country names against the Oracle Site Select standard country names. Import behavior is:
  • CSV import – A site row with an invalid institution country errors and that site record is not imported, but it is included on the import error list. Because the CSV import utility streams each record, a site record with an invalid institution country will be skipped and the next record will be processed. The list of error sites displays after the import process has completed.
  • API import – An import of an institution record with an invalid country errors and the institution record is not written. If one record in a batch errors, the entire batch fails.