regarding period completion for a subject in a study [Study Per­for­mance]

posted by drgunasakaran1  – 2012-11-01 04:25 (4981 d 09:05 ago) – Posting: # 9489
Views: 5,627

Dear Mr Varsha,

❝ The question is whether his period shall be considered as completed or not.


The period is not completed since ambulatory samples should be considered as part of the study period.

❝ Just clarify me whether a period is considered from check-in to check-out or ambulatory samples are also considered as a part of a period.


The Period should be considered from Check-in to Last ambulatory sample collection.

❝ There were three ambulatory samples for the project which he didn't attended. Will these samples be considered as missing samples?


These samples should be considered as missing samples. The reason for missing samples should be clearly denoted as "Due to Adverse Event". The adverse event form should be filled for the same.

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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