article thumbnail

Important factors to consider when working with CRFs

pharmaphorum

Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry. Avoid gathering more data than what is needed. Provide form completion guidelines to reduce data capture and data entry issues. Avoid duplication. Get user feedback.

article thumbnail

Considerations for safety data migration methods

European Pharmaceutical Review

Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon. Once all cases have been entered and reviewed and any discrepancies resolved, the data transfer is considered complete and a data migration summary report should be issued.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

As clinical trials generate a massive amount of data, it can be challenging for researchers to manually review all of this data to uncover meaningful insights. For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document.

article thumbnail

Advancement through adversity: how Covid-driven innovations are becoming best practices for pharmacovigilance

Pharmaceutical Technology

The process of actioning case reports is typically split into six stages: case receipt, triage (deciding whether a case should be classified as serious, non-serious or a non-event), data entry, quality review, medical review, and submission.