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Dear All,
What is the difference between withdrawal / dropout? After end of the
study
can we considered as both as withdrawal.
Regards,
Srinivasa Reddy.E
Quality Assurance Unit
Clinical Pharmacology Department
Trident Life Sciences Ltd
Hyderabad - 500 050
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Dear Srinivas,
> What is the difference between withdrawal / dropout?
When the investigator decides a subject's study termination, it is
said to be Withdrawl.
For eg: Adverse Events
If the subject wants to cancel his participation voluntarily, then it
is considered as a Drop-out
For eg: Absent due to personal reasons
> After end of the study can we considered as both as withdrawal
We can consider both as one in the PK side, as there will be some
missing data (incomplete profile) in both the cases.
But, they should be dealt seperately, when it comes to Clinical
perspective, as 2 different forms are used in many CROs to record
these events.
Experts can clarify, if I am on the wrong opinion.
Habeeb Ibrahim
GVK BIO
Hyderabad
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Dear srinivas,
if a subject withdraws from a clinical phase of the study due to
personal reason or
we withdarw him/her during the study because of adverse effect
or noncompliance, it is considered generally as withdrawal.
if we exclude a subject for analytical phase due to missed samples or
missed periods,it is said to be drop out.
experts opinion welcomed
regards,
muhiyideen
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