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Updated: Sep 11, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Impact of Protocol Amendments, Personnel Experience and Social Determinants of Health on Study Protocol Adherence in

K N Cilley1, A O Kaliaev2, M A Malikova3

  • 1Department of Surgery, Boston University, Chobanian and Avedisian School of Medicine, Boston Medical Center, 85 East Concord Street, 02118, Boston, MA, United States.

Therapeutic Innovation & Regulatory Science
|August 16, 2025
PubMed
Abstract

Keywords:
Combination productsData integrityGood clinical practice (GCP)Protocol adherenceProtocol amendmentsProtocol deviationsRisk-based approachSocial determinants of healthStudy protocol complexityStudy staff experience

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