A clinical trial protocol is amended when it has been identified that the current protocol version requires modification (e.g. changes to screening or timelines for assessments/procedures). The clinical trial protocol document itself is modified and a new version is created. In addition, a protocol amendment summary document is created that details the rationale for the changes and itemizes the protocol sections to be modified, specifically summarizing the new text that will replace the existing text.
The purpose of this assignment is to create a clinical trial protocol amendment summary document. You will be provided with a mock clinical trial protocol along with a scenario listing the specific changes that need to be made.
This assignment provides you with an opportunity to demonstrate the achievement of the following course learning outcomes:
· Evaluate the components and framework for the development of a clinical trial protocol while ensuring adherence to ICH GCP guidelines, ethics, and regulations that govern clinical trials in Canada and the United States.
· Create a clinical trial protocol amendment summary based on a scenario, specifically identifying protocol sections for modification and providing a written rationale for each change.
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