Page 168 - eBook Version 8 Book 1 of 2 JUL 2022
P. 168
Protocol Deviations:
1. Labsareoutofwindow.
2. Studyvisitisoutofwindow.
3. The6MWDwascompletedafterreceivingstudydrug.
4. UsedthewrongformfortheQualityofLifeAssessment.
5. ExpiredLabkitwasused.
6. Thedrugwastitratedwithoutthesubjectsmeetingthequalifications.
Protocol Violations:
• The subject’s lab values did not qualify the subject for enrollment at the time of randomization, but they were randomized.
