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Feb 24, 2025 · Protocol amendment is a formal and documented changes made to the study protocol. These changes can encompass modifications in study design, study procedures, …
Dec 11, 2024 · Protocol amendments are inevitable in almost all studies. In fact, many Phase 1 studies undergo five or more amendments. To clarify some common practices, here are essential …
Ensure everyone is informed of the protocol amendment. If training is deemed necessary, the Sponsor must provide training on the revised documents and document the training. A Protocol …
Where any trial-related committees (e.g., IDMC) are utilised for the purpose of assessing safety data, procedures, timing and activities should be described in the protocol or a separate document.
Jul 9, 2025 · This tutorial explains when a protocol amendment is necessary, how to implement changes correctly, and how to comply with global regulations such as those from USFDA and EMA.
A sponsor shall submit a protocol amendment when a new investigator is added to carry out a previously submitted protocol, except that a protocol amendment is not required when a licensed …
Sponsors are expected to submit protocol amendments for new protocols or changes to existing protocols before implementation of the respective changes.
When proposing changes to an existing study, it is important to consider whether the changes may warrant submission of a new protocol rather than an amendment. It is a misconception that …
Once the responsive material from the investigator meets the requirements for approval, approval is documented on the Protocol Amendment Request, and notice is sent to the investigator; the …
Review. If you have significant changes to make, first submit and obtain approval of the Continuing Review application, then submit an Amendment. Log in to eProtocol with your CalNet ID & …
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