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Can you add additional testing on the same subject to the dataset, particularly when it is hard to find study subjects?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

In most studies, you should avoid multiple testing of the same subject because it may skew performance statistics and underestimate standard deviations. When multiple testing is done, you should explain why it is necessary and choose methods of statistical analysis that allow adjustment for within-subject correlation. It is appropriate to conduct repeated testing of the same sample to evaluate test reproducibility, such as the ability of the test to yield the same or similar readings when expected.

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