protocol Deviations due to visits -- how to prevent

[judith_sylvia]

Do you have an example of a statement in a protocol that allowed variations to visit windows and thus out of window visits (not on the scheduled day) were not deemed protocol deviations. Currently, a statement to this effect is not in the protocol and the PI does not want to have a window of say 3 days, but it is a logistical nightmare regarding data management and monitoring reports.

[RPR Consulting]

The protocol needs to be followed otherwise, by definition, there is a protocol deviation. If you need longer windows then this should be included in an amendment.
Whether of not the subsequent protocol deviations are deemed to be "significant" from a subject welfare or data integrity perspective should then be determined by the project team, including the Medical Monitor, Clinical Scientist and Statistician.

[a123456]

ICH has an excellent document ICH E3
EMA/CHMP/ICH/435606/2012
Committee for medicinal products human use (CHMP)
ICH guideline E3 - questions and answers (R1)
Step 5. July 2012

Q; What is the distinction between a protocol deviation, important protocol deviation, and a protocol violation?