Step 1: Identify Required Changes


Before you can begin the amendment process, you must identify your required design changes.

Some examples of common amendment reasons include:

Updates to Study Protocol

After an interim analysis, a sponsor may decide to add a new visit to an existing study.

Errors in Existing Design

Due to human error, there may be errors in the existing design. You can use amendments to update the design and resolve these errors.

Updated Input & Output Requirements

During the course of your study, a regulatory agency may announce a new requirement for collecting a certain data point. You can use an amendment to add data collection for that point to your study.