Bulk data change requests

The data manager prepares one change for many records, the sites confirm it as a batch against their source documents; everything is in the audit trail.

A bulk data change request (DCR) is for when the same mistake is in many records. For example, the sites entered a wrong unit, or the protocol clarified which option records an answer. The data manager prepares one change of one field for all those records. Each site compares its records with the source documents and confirms them as a batch or rejects single ones. Only confirmed records change.

How the data manager prepares a request

In the study menu, open “Data change requests” and press “New request”. Choose the form and the field. If needed, narrow the choice by visit, site and the value now: for example, only the records where it is “mg/dl” now. Give the new value (for a choice, its code or its text works) and press “Show the records”.

The portal shows which records would change: what was and what it becomes. It also shows how many records were not taken and why. Not taken are forms the patient sent (they are corrected by an ePRO correction request), locked forms, records where the field is hidden and records where the form with the new value would fail its checks. Write the reason (the sites read it) and press “Make the request”. One request holds up to 1000 records.

Nothing changes before a site confirms. The request can be withdrawn with a reason: records already confirmed stay changed, the waiting ones are not changed.

How the site confirms

A request as the site sees it: some records already changed, one rejected with a reason, the rest chosen to confirm.

The number on the menu item “Data change requests” shows how many records of your sites wait for an answer. In a request the site sees only its own patients: what was, what it becomes and the data manager's reason. Compare the records with the source documents. Clear the box of the ones you do not confirm, tick “I compared the chosen records with the source documents” and press “Confirm the chosen records”.

If the source document says otherwise, press “Reject” on the record and write what the document says. The record stays as it is, and the data manager sees why. The one who made the request cannot confirm it.

What happens to the data

• A confirmed record changes like any correction. The audit trail gets a record of the value with the old and the new value, the request number and its reason. SDV and the data manager's approval of that form fall, as on any change.
• If the value was changed in the meantime or the form was locked, the record is not changed and gets the status “Not changed: the record changed”.
• Making, rejecting and withdrawing a request are in the audit trail too.
• Forms hidden by blinding never get into requests.