Previous Topic

Next Topic

Book Contents

Suggested workflow for tracking manual transaction edits

To ensure auditability and regulatory compliance of edits to synchronization transactions in a production environment, the following workflow and guidelines are recommended:

  1. Use the transaction editing feature of CIS Administration primarily as a system implementation tool. In production, use it only when no other solution to a synchronization failure is available.
  2. Before changing a synchronization transaction, notify the investigator of the planned action and obtain formal signoff indicating that the investigator agrees to the action.
  3. At the site, maintain a manual log of the occasions on which you edit synchronization transactions. This log should record:
    • The user who performed the edit.
    • The date and time of the action.
    • The trial or protocol in which synchronization transactions were edited.
  4. Update the data in the InForm software if necessary to reflect the change.
  5. When an audit of integrated study transactions is required, query the INF_MSGEDIT_HISTORY table for each trial in which synchronization transactions were edited to produce the audit record of those actions. At a minimum, review the INF_MSGEDIT_HISTORY table as part of the database locking process. If any records exist, verify the existence of the required paper documentation at the site.

Note: If you do not follow similar steps to make sure your audit trail is complete, you may be using the CIS software in a way that is not fully compliant with CFR 11.

Send Feedback