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Clinical Sas Notes

The document outlines the steps involved in conducting a clinical trial, starting from protocol creation to FDA approval. It details the processes of investigator selection, subject recruitment, data entry, data analysis, and medical writing, highlighting the roles of various teams and tools used, such as CRFs and EDC. Ultimately, the findings are compiled into a Clinical Study Report (CSR) for submission to the FDA.

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akhilesh
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29 views2 pages

Clinical Sas Notes

The document outlines the steps involved in conducting a clinical trial, starting from protocol creation to FDA approval. It details the processes of investigator selection, subject recruitment, data entry, data analysis, and medical writing, highlighting the roles of various teams and tools used, such as CRFs and EDC. Ultimately, the findings are compiled into a Clinical Study Report (CSR) for submission to the FDA.

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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Download as DOCX, PDF, TXT or read online on Scribd
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1.Protocol: It is a plan or outline of clinical trial.

In this document sponsor has to mention everything about clinical trail like how many days trail to be
conducted, where is to be conducted, what kind of drug to be studied.

Once the protocol is ready ,It is sent to FDA.If he gets approval from FDA then it is known as
approved protocol.

2.Investegator Selection: Investegators are hired based on clinical trail.

3.Subject Recruitment: On what basis we need to recruit the subjects those details are mentioned in
protocol which are Inclusion and Exclusion criteria.

The Clinical Research monitors team will monitor the subject recruitments.

4.Data Enry team : The data will captured when trial is being performed like if there any AE events
happened etc.

CRFs contains various types of questions like medical history, demographics etc.

They enter the data into CRFs (Case Report Forms).

We 2 types CRFs

1) Paper CRFs
2) eCRFs

We use eCRF which is directly converted into Database tables.

Instead of eCRF now a days people are entering the data directly into database which is named as
EDC(Electronic Data Transfer) which very secured and accesable all around the world.

Data validation is done by data management team by manually or Edit checks.( like constraints in
columns)

The data which is entered by data management team is known as Raw Data.

5.Data Analysis: Biostatisticians and SAS programmers are involved in this step

Biostatisticians have their own document called SAP(Statictical Analysis Plan) which is prepared using
CRF.

In SAP what are the reports need to be generated and what are the analysis they need those data is
captured in SAP.

Biostatisticians ask SAS programmers to generate the reports based on SAP.


They provide some templates or mock shells and data based on that SAS programmer need to
prepare the report.

6.Medical writing Team: The reports are analysied by medical writing team and write some
conclusions which is given to statistician who will prepare CSR(Clinical Study Report) which is
submitted to FDA.

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