Presentation - Bioequivalence and Bioavailability

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1. Custodian
responsibility
1.Facility
of
readiness
2.Frishking
3.Restricted
item

Responsibilities of a Custodian
(MCS-SOP-CPP-024 R00)

2. WITHDRAWAL/DROPOUT FROM CLINICAL STUDY
MCS-SOP-CPP-029 R00
Withdrawal Criteria

If any subject withdrawal
decision taken by PI/CO-I/Mo

Due to adverse event or any
other reason.

In case subject take any drug
other than study drug study.
Drop-out Criteria

Withdrawal by Subject

Protocol Violation

Did not report for subsequent
periods of the study

Study terminated by sponsor

3. TRANFER OF A SUBJECT TO THE CONTRACT HOSPITAL & READINESS
0F AMBULANCE (MCS-SOP-CPP-028 R00)
Subject All
Details
Ambulance
Check List
First Aid Box
SUBJECT TRANSFER TO CONTRACT HOSPITAL IN CASE
ME/AE/SAE