Validating electronic source data in clinical trials

Estimated reading time: 2 minutes 21 CFR Part 11 Clinical Research Technologies Compliance and Regulatory Data Management This is Part 2 of a two-part series.

For the previous Q&A, read, Examining 21 CFR Part 11 and the Role of Technology – Q&A (Part I).

Clinical database validation is making sure that clinical databases perform the functions required by regulations and guidances and is on another page.

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The system used was developed to alert the AMT of potentially inadequate antimicrobial therapy.

This is the first study that demonstrates in a patient-randomized controlled trial that computerized clinical decision support systems can improve existing antimicrobial management programs.

Disambiguation: Clinical data validation means checking clinical data for correctness and completeness.

The European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

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