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I am renuka working in microtheraps, chennai.
Please do clarify my doubt.
Question:
In a phase I clinical trial a subject receives investigational
product (test or reference) in period I while he did not check in to
the clinical facility for period II.
How to report this?
Regards,
Renuka.
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The following message was posted to: PharmPK
Dear Renuka
The subject should be reported as Lost to follow up
(in other ways termed as Drop out).
V.Rajesh
CRA-Omnicare Clinical Research Pvt. Ltd
INDIA
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The following message was posted to: PharmPK
Hi,
It should be reported as drop out and ever effort has
to be made to know the reason for the same.
Regards,
Dr.Sridhar
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The following message was posted to: PharmPK
dear renuka,
discontinue that subject on volunteer ground (personal ground).
do further for study completion safety analysis for that subject.
paresh
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Dear Renuka,
The subject can be considered as DROP OUT. But, the POST STUDY SAFETY
EVALUATION has to be done, as he/she has administered the study drug.
If any Laboratory parameter goes wrong in the post study evaluation
(or differ significantly from the PRE-STUDY SCREENING EVALUATION),
the subject has to be called for FOLLOW-UP & treatment/advice
(depends upon the parameter) has to be given, untill that parameter
becomes clinically not significant.
If the subject doesnt co-operate (or is not reporting to the facility
due to personal reasons), he/she can be considered LOST FOR FOLLOW-UP.
Thanks & Regards,
Habeeb Ibrahim,
Wellquest Clinical Research,
Nicholas Piramal India Ltd.,
Mumbai
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The following message was posted to: PharmPK
Dear All
Regarding safety analysis at the end of study/drop
out, it should be done only if the protocol had
specified that the safety analysis needs to be done at
the end of study. I do remember that some of the
studies do not require safety analysis to be done at
the end of study.
Moreover, if the subject did not turn up to the
facility after drop out for one month then the need
for safety analysis does not meet the purpose. In such
cases only a documentation stating the reason for not
performing the safety analysis after drop out is
required.
Dear members, please correct me if I am wrong.
V.Rajesh
CRA
Omnicare Clinical Research Pvt Ltd
INDIA
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The following message was posted to: PharmPK
Raaj:
You are correct that not all studies have a safety analysis specified
in their protocols; however, if subjects withdrew due to
unanticipated adverse events then that would need to be reported to
the Regulatory Agency and that may in turn trigger a safety analysis.
Similarly, unanticipated adverse events occurring 30 days that an
investigator reasonably believes is due to the investigational agent
would still be required to be reported(at least for the FDA this
requirement would supersede any protocol). The "30 day rule" which
is really a convention doesn't make a lot of sense. Certainly some
common sense needs to be applied but we know some therapeutic agents
have effects far longer than 30 days.
Sincerely,
Carol Collins MD,RAC
Senior Research Scientist
University of Washington
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