Global health amendments

What is an amendment?

If you need to update the protocol, study documents, or how the study is conducted, submit the proposed changes to your Global Health Sponsor Representative for review. They will advise on the category the changes fall under, and provide guidance on the next steps for submitting the amendment to the relevant ethics committee(s) and local regulatory authority, as appropriate. 

Changes can include adding a new site, extending the dates of a research study, changing the number of participants, typographical changes, or amending the study design and procedures. 

Types of amendment

The approvals needed for an amendment depend on the type of study and the classification of the amendment – your Global Health Sponsor Representative can help you determine which category your amendment falls into:

• Non-substantial amendments: Minor administrative or procedural changes with no effect on participant safety or data integrity  
• Substantial amendments: Changes that could affect participant safety, rights, or the scientific validity of the study

Submit the following to your Global Health Sponsor Representative, quoting the Sponsor reference study AC number:

• A summary of the changes being made
• All documents that are changing, version-controlled, with the amended information highlighted as tracked changes

Your Global Health Sponsor Representative will review the amendment, categorise it and send you an email confirming they approve the changes.

The amendment should first be submitted to the relevant University of Edinburgh ethics committee. Once approval is received, it can be submitted to the local (in-country) ethics committee and, where applicable for regulated clinical trials, to the local regulatory authority.