Activity

  • myton replied to the topic Change Requests During Clinical Trials in the forum Project Management Application: Clinical Trial 7 years, 11 months ago

    As previously mentioned, it is more difficult to implement a design change during clinical trials than compared to during the design process. When entering a clinical trial, it is important to note that the FDA outlines specific aspects of the design and its goal is to evaluate the most current design. By adding design changes, it would mean that there should be a new clinical trial depending on the weight of design change. A design change could imply that there would be a change in the protocol of the testing, the subjects to whom the tests will be performed, etc. Either way, if it is necessary, the change has to be made and the team and the project must adapt to the new situation. It is integral to have an adaptable team to do so. In my opinion, if the change is necessary for the project to make it a perfect then the team should be willing to accept these changes.