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Clinical Notes

The document outlines the requirements for producing a-CRF, focusing on treatment-related data and various domains such as SDTM guidelines, subject visits, and adverse events. It emphasizes the importance of tracking subject details and treatment phases in clinical trials. Additionally, it mentions the need for coding and merging data across different domains for accurate reporting.

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akhilesh
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25 views47 pages

Clinical Notes

The document outlines the requirements for producing a-CRF, focusing on treatment-related data and various domains such as SDTM guidelines, subject visits, and adverse events. It emphasizes the importance of tracking subject details and treatment phases in clinical trials. Additionally, it mentions the need for coding and merging data across different domains for accurate reporting.

Uploaded by

akhilesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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To Produce a-CRF we need above guides.

Domain:
All treatment related stuff.

SDTM guidelines:
CORE:

ROLE:
TOPIC: It gives the information entire domain.
DM:Primarly talks about all subject related details.
- We are intended to go for study drug but patient is having some issues so before studying
actual drug we are giving some treatment.
Actually we planned for one drug but we are implementing another drug -> ACTARM.

SUBJECT VISIT(SV):
Subject can have Unscheduled visits.

Used for sorting the Data.


Calculates the days per visit of subject from the BaseLine(Tretment Start Date).

Ex:

SUBJECT ELEMENT DOMAIN:


ELEMENTS- are nothing but phases in clinical trail.
Code to create SESEQ
COMMENTS DOMAIN(CO):
AE(Adeverse Event Domain):
Based on this code we will merge the metradictionary code.
MH DOMAIN:
DS domain:
CE Domain:
CM domain:

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