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Amending a Protocol vs. Submitting a New Protocol 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 adding an amendment to an existing study will be easier and faster than submitting a new protocol
Amending an Existing Protocol vs. Submitting a New Protocol: For example, if the only changes involve substituting one questionnaire for another similar one or adding different stimuli of the same type, then submitting an amendment is likely the best course of action
eCFR :: 21 CFR 312. 30 -- Protocol amendments. A sponsor shall submit a protocol amendment for a new protocol or a change in protocol before its implementation Protocol amendments to add a new investigator or to provide additional information about investigators may be grouped and submitted at 30-day intervals
Jamie - Your Personal AI Note Taker Jamie creates the best AI meeting notes and action items across any meeting platform and even offline No meeting bot needed and privacy-first approach
IND Protocol Amendments: IND Protocol Amendments Guidance and Template . . . If a sponsor-investigator wants to open a new protocol under an existing IND, then sponsor-investigator must submit the new protocol to the FDA for review A new protocol is one that is not covered by a protocol already contained in the IND
When do proposed changes warrant a modification or amendment request . . . r a new protocol, consider the following: Do the roposed changes alter the research hypotheses? Is there a change in the study purpose and or aims? • If he basic research question or purpose remains intact, then a new application may not be warranted • If the research question has changed, even if it build o
Protocol Deviation User Guide - CTSU The scope of the pilot is one protocol per participating Lead Protocol Organization (LPO) Feedback from LPOs and sites participating in the pilot may result in revisions to the Protocol Deviation Form or process for future protocols This guide will be updated after the pilot to reflect revisions
Amending a Protocol vs. Submitting a New Protocol 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 adding an amendment to an existing study will be easier and faster than submitting a new application
How to Write Site-Friendly Protocol Amendments in Clinical Trials How to write site-friendly protocol amendments in clinical trials? Protocol amendments can be complicated, and they require orchestration across multiple parties – sponsors, sites, and vendors – to ensure that the correct protocol information is being adhered to