Clinical Trial Amendment FAQ

How does the platform ensure consistency in document amendments?
The platform centralizes all information, meaning any amendments made are instantly rolled out across all relevant documents. This eliminates conflicting information and ensures that all documents are always up-to-date and consistent with each other.
Can multiple users collaborate on amendments simultaneously?
Yes, the platform supports collaborative editing, allowing multiple users to work on amendments at the same time. This feature enhances teamwork and ensures that all necessary updates are made efficiently, without the risk of version control issues.
Is it possible to create multiple versions of amendments without altering the original document?
Absolutely. The platform allows you to create multiple versions of amendments without modifying the original document. This feature is beneficial for maintaining a clear audit trail and for referencing previous versions if needed.
How does the platform minimise human error during the amendment process?
By automating the amendment process and reducing the need for manual document handling, the platform significantly minimises the risk of human error. Users do not need to interact with the Word documents themselves, but rather rely in making desired changes centrally via the platform.
What benefits does the platform offer for managing large, complex amendments?
For large, complex amendments, the platform ensures that all relevant wording is updated simultaneously across all documents. This streamlines the process, reduces administrative burden, and saves valuable time, allowing your team to focus on critical aspects of the trial.
How do I track changes made during the amendment process?
The platform creates a separate environment for each amendment that is separate from other versions. Whilst changes are not tracked with markup, any saved updates to the forms are available via the audit trail where users are able to see the saved values made by other collaborators. We are currently working to create a tracked changed feature to easily track updates to text with markup.
Clinical trial documents

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