Amendments – Overview

Modified on Fri, 25 Apr at 1:27 PM

Learn more about how to proceed with amendments within an active study.

⚠️ Please note: Amendments can only be implemented in the sandbox environment. Please read the following article first: Sandbox Environment - Updating Active Studies and Surveys

⭐ What is an amendment? And amendment means that your study is active and includes real data, and you wish to add/change/delete something within the set-up.

⚠️ Every executed amendment will be shown in the Audit Trail.

⚠️ Making an amendment should be thought through very carefully because in some cases this can cause data loss. Please check your specific amendment first in the overview below.

⭐ Good to know

As part of quality assurance, a banner appears in the system while an update to the study setup is being saved, indicating that the changes are being saved in the background and no further changes can be made. This banner will automatically disappear as soon as the saving process is completed. Once the changes are successfully saved, you can continue to make further updates in the study, if desired.

⭐ Following the progress of an amendment

In addition you will see a progress bar to follow the progress of the amendment taking place.

⭐ In case of amendment failure

It can, due several different circumstances, happen, that an amendment fails. In this case you will be informed and have the option to take two actions:

1. Retry the amendment

2. Roll back the changes you have made

We recommend to first use the retry option, if the amendment still fails after retrying 5 times, you will automatically be asked to roll back your changes and contact our support team. In this case, we strongly advise to stop making any further changes to your study setup.

If you roll back your changes, the study workflow settings will be reverted to the last successfully saved state (the timestamp is mentioned in the warning pop-up).

Important: Changes to data entries in the eCRF or ePRO forms will not be affected by this roll back action.

Overview of Amendments (within study set up)

Forms (Step 3)

Property	Action	Impact	Details
Export label of Input Field	Change	✅	The new export label will apply to all data entered in this Input Field moving forward.
Description of Input Field	Add/Change/Delete	✅	This will not affect your data, but can have an impact on the future user experience.
Placeholder of Input Field	Add/Change/Delete	✅	This will not affect your data, but can have an impact on the future user experience.
Rich text	Add/Change/Delete	✅	This will not affect your data, but can have an impact on the future user experience.
Dependencies	Add/Change/Delete	✅	This will not affect your data, but can have an impact on the future user experience.
Locking of Form	Add/Change/Delete	⚠️	See more in this article
Export label of Form	Change	⚠️	See more in this article
Hierarchical Signature	Change	⚠️	See more in this article
Whole Input Field	Add/Delete	⚠️	See more in this article
Display label	Change	⚠️	See more in this article
Required/Optional	Change	⚠️	See more in this article
Value	Add/Change/Delete	⚠️	See more in this article
Validations	Add/Change/Delete	⚠️	See more in this article

Workflow (Step 4)

Property	Action	Impact	Details
Reply to email	Add/Change	✅	The new address will apply for any reply moving forward.
Order of Workflow	Change	⚠️	See more in this article
Step/Form	Add/Delete	⚠️	See more in this article
Step type: ePRO/Visit event	Change	⚠️	See more in this article
Reminder of ePRO	Add	⚠️	See more in this article

✉️ Still have questions? Feel free to contact your Customer Success Manager or email us at support@climedo.de.