Clinical Data Management and Paired t-test in SAS
In this blog I have written about clinical data management
and in the end of this blog there is demonstration of paired t-test in SAS.
While we learn about clinical data analysis, we should also
know about how this clinical data collected and where it is stored.
Clinical data management is about collecting, validating and
locking the clinical data that is generated in clinical trials in compliance
with regulatory standards.
There is this term that is mostly used CRF (Case Report
Form) suppose you are conducting a clinical trial which involves 20 patients.
Now you have to have store the information about those patients about their
height, gender, weight or any adverse or severe adverse event. So, to store
this information CRF is used; it can be filled manually or software based
(ECRF).
Just like we have GCP/GMP here we too have good clinical
data management practices.
In fact, you can explore CDISC website.
CDISC: Clinical Data Interchange Standards Consortium
It is a website which provides certain guidelines to store
clinical and non-clinical data in a certain acceptable format and transforming
the whole data collection and managing process in a powerful framework.
Well that’s all about CDM there are more topics that I encourage you to explore.
Discrepancy management: How clinical data manager resolves
any errors or discrepancies present in clinical data?
https://www.slideshare.net/KatalystHLS/discrepany-managementkatalyst-his
If you want a quick overview on ICH guidelines
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| Code in editor window in SAS |
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| Output: Descriptive of given data |
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| Weight loss data in SAS |
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| Code in Editor Window |
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| Output of paired T-test weight0-weight1 |
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| Code in Editor Window |
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| Output of paired T-test of weight0-weight2 |
Considering 10% of level of significance there was statistically significant difference between initial weights and final weights of the subjects.
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