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Please Pass the New Template: Enhancement of Postauthorization Safety Study Protocol Templates Aligned With Guidelines

Time

Wed, Jun 26 11:45AM
W 21

Title

Please Pass the New Template: Enhancement of Postauthorization Safety Study Protocol Templates Aligned With Guidelines

Abstract Summary

We aligned our templates the Guideline on Good Pharmacovigilance Practices–module VIII (GVP; www.ema.europa.eu) and ENCePP Checklist (www.encepp.eu), reviewed other guidelines (eg, International Society for Pharmacoepidemiology [ISPE; www.pharmacoepi.org], International Conference on Harmonisation [ICH]) for additional language. Typical study designs were identified and we searched the literature for associated design-specific language. Within each template section, potential text was evaluated for inclusion. Identified concepts and language was denoted as additional instructional or sample template text with sample text further marked as required, preferred, or optional text. Templates were further evaluated by the protocol development team participants for usability.

Poster Presenter

Diane Carpentier
Director, Life Sciences Business Development,
Optum
United States

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