The writer is very fast, professional and responded to the review request fast also. Thank you.
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.
Read less
Delivering a high-quality product at a reasonable price is not enough anymore.
That’s why we have developed 5 beneficial guarantees that will make your experience with our service enjoyable, easy, and safe.
You have to be 100% sure of the quality of your product to give a money-back guarantee. This describes us perfectly. Make sure that this guarantee is totally transparent.
Read moreEach paper is composed from scratch, according to your instructions. It is then checked by our plagiarism-detection software. There is no gap where plagiarism could squeeze in.
Read moreThanks to our free revisions, there is no way for you to be unsatisfied. We will work on your paper until you are completely happy with the result.
Read moreYour email is safe, as we store it according to international data protection rules. Your bank details are secure, as we use only reliable payment systems.
Read moreBy sending us your money, you buy the service we provide. Check out our terms and conditions if you prefer business talks to be laid out in official language.
Read more