Adhering to Good Clinical Practice (GCP) ensures data integrity and transparency during clinical trials. In CDMS, users must provide a reason when changing previously entered data to comply with GCP standards. This helps track changes and maintain an audit trail.
Enabling GCP Features
To enable this feature:
- Navigate to Settings, then Study under the Good Clinical Practice tab.
- In the Confirm Changes section, select Yes to activate the feature.
- This is the primary toggle that enables or disables the Reason for Change functionality for any data edits across the study.
- Options:
- Yes: Requires users to provide a reason whenever data is changed after it has been saved.
- No: Users can edit data without providing a reason.
When Yes is selected, additional settings for study visits, repeating data, and surveys become active.
Study Data Entry - Adding a Reason for Change
- For study visits and repeating data, the system is configured to require a reason for every field edited.
- Once the GCP feature is enabled, users must justify any modifications to previously saved data.
- Users must provide a reason whenever they attempt to change a previously entered value.
- The system allows users a 30-second grace period after entering data to make corrections without requiring a reason.
- If data is being entered for the first time and the grace period hasn’t expired, no reason for change will be required.
Example Scenario:
Imagine you entered an incorrect value in a field and need to change it:
- Select the correct value.
- A dialog window will appear, prompting you to provide a reason for the change.
- Enter the justification in the ‘Reason for Change’ field.
- Click Continue to save the new value with your reason logged.
Modern Data Entry (from 2024.2 version)
Surveys - Reason for Change
There are three options for managing "reasons for change" specifically for survey data:
Require a reason for each and every field edited:
- Every time a survey response is edited (after the initial entry), the user is prompted to provide a reason for the change.
Require a reason for the first edit, then reuse for subsequent changes:
- The user provides a reason only for the first change in a session or form.
- The same reason is automatically applied to subsequent edits within the same session or form.
Do not require a reason for editing any fields:
- This disables the "reason for change" requirement for survey data edits entirely, allowing users to make edits freely without justification.
For surveys, the Reason for Change functionality behaves in the following way:
- When a user attempts to update survey responses that have already been submitted, the system will prompt for a reason before saving changes.
- The Reason for Change dialog will provide context for the update, ensuring changes are logged appropriately for audit purposes.
- Similar to study data entry fields, the system allows users a 30-second grace period for amendments without requiring a reason.
- The Reason for Change will not trigger for newly entered responses during an initial session unless changes are made after the grace period.
- Each field in a survey requiring an update will trigger the Reason for Change dialog individually, ensuring detailed tracking for every amendment.
- Changes made without providing a reason (if required) will not be saved, ensuring compliance with GCP standards.
- The reason for change will only appear for the study team member, if a survey participant is making the change, the dialog window will not appear
Modern Survey Data Entry