Examples of flag use

Flags can help track the data review process or move the process along:

You can create the following flags and write validation check custom programs that examine data and call the public API dme_pub_flag_data.setFlag to set the flag. See the API guide for information about initializing APIs.

• Create a flag called Needs Review with states Medical Monitor and Data Manager. These users can then check for data needing their review.

• Create a flag called Record Complete with two states: Yes and No. Data managers can use this flag to filter for missing data.

  Write a custom program to ascertain that all required fields in a record have a value and apply the flag with the state Yes if they do.

• Create a flag called Validation Checks with the states Validation Not Done, Validation Incomplete, and Validation Complete.

  Write a custom program that compares the timestamp of the last data update for each unlocked record to the execution timestamp for all validation checks run for that study and sets the Validation Checks flag for each record with the appropriate state.

• Create a flag called Data Readiness with states: Not Clean, Clean for Medical Review, and Clean for Analysis. Medical reviewers and statisticians can then query for data with the appropriate flag for their review.

  Write a custom program that uses the above flags or others to set its values.

• Create a subject visit flag called Subject Visit Complete with a single state of On, to be applied only when the subject visit is complete.

  Write a custom program that aggregates flag values for the individual clinical record flags in the examples above: loop through each subject/visit combination and set the Subject Visit Complete flag to On when every record for the current subject and visit in the Adverse Events, Concommitant Medications, and Vital Signs tables, for example, has the Record Complete flag set to On, the Validation Checks flag set to Validation Complete, and the Number of Discrepancies set to an acceptable number.

A validation check can apply a flag to records if it has a custom program that calls the API DME_PUB_FLAG_DATA.SetFlag. The API requires the target table instance object ID and the record's surrogate key value as input. See the and the Oracle Health Sciences Data Management Workbench Application Programming Interface Guide for more information.