Understanding Discrepancies and the Management Process

Discrepancy management is the process that systematically addresses discrepancies generated within a study. Correcting and managing discrepancies ensures that the data is complete, accurate, and compliant with the study protocol.

Discrepancies Raised in the Validation Process

RDC Onsite checks and validates patient data at the following times:

• As you enter data or when you save a CRF, RDC Onsite executes simple edit checks and then flags any data entry errors. You can choose to correct these discrepancies immediately during the data entry process.

• During the patient validation process, RDC Onsite executes complex edit checks, typically relating to values that do not correlate across CRFs. You can conveniently execute patient validation after you complete the data entry for a visit.

  Note:

  Edit checks, depending on how they are configured, can:

  • fire when the CRF is saved
  • fire when running the patient validation job

  • fire outside of your RDC session

    If a CRF shows a red icon on the surround but upon opening shows no active discrepancy then it is likely the data has been modified but is associated with a Multivariate discrepancy that is still current / was created by an offline procedure. In this case the regular study-wide batch validation will pick up the discrepancy and obsolete it. Once the discrepancy has been closed then the CRF icon will no longer appear as red.

• If patient validation is not executed, regular nightly study-wide batch validation raises the discrepancies that would ordinarily be caught by patient validation. In addition, batch validation executes edit checks that are even more complex and are not efficient to execute in an online session.

Manual Discrepancies Added by Users

In addition to the discrepancies that RDC Onsite generates, you can identify discrepancies by a visual review of the data. Users with the proper privileges can question information in a CRF and create a manual discrepancy for others to review.

Your Goal: Resolve All Discrepancies and Ensure Clean Data

For each discrepancy assigned to you, you must identify the cause, assess the error, and determine the appropriate action.

You can choose to immediately resolve the discrepancy as it is raised, or you can defer the resolution for later. In addition, you can route a discrepancy to another user. Your goal is to resolve all discrepancies associated with every CRF and to ensure clean data.

You use the following general procedure to manage discrepancies:

• Search for CRFs with discrepancies
• Open the CRF in the Data Entry window
• Use the tools in the Data Entry window to resolve a discrepancy, route a discrepancy, or create a manual discrepancy