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Clinical Research Coordinator Analysis

IP Self-Administration: Training, Competency, and Home Compliance

Finding: The protocol (Sections 5.4.1, 6.3) permits participant/caregiver self-administration of the subcutaneous Investigational Product (IP) after the first dose, with training materials to be provided by the Sponsor. However, from a site operations perspective, there is a potential challenge in ensuring consistent and comprehensive training, verifying participant competency beyond initial instruction, and systematically monitoring IP storage and administration compliance at home. Lack of detailed, standardized site-level procedures for these aspects could lead to variability in IP handling, adherence, and documentation. Recommendation: Request that the Sponsor-provided training materials include not only instructional content but also a standardized competency assessment checklist for site staff to use when training participants/caregivers. Furthermore, provide sites with clear guidelines and suggested tools (e.g., participant temperature log templates for home refrigerators, self-administration diaries) to facilitate consistent monitoring and documentation of IP storage conditions and administration adherence for participants managing IP at home. Clarify how deviations in home storage or administration should be documented and reported by the site. Rationale: Implementing standardized competency assessments and providing tools for home compliance monitoring will enhance participant safety, ensure data integrity related to IP exposure, reduce the risk of protocol deviations related to IP mismanagement, and improve consistency across sites, ultimately strengthening the reliability of the trial results.