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Clinical Research Coordinator Analysis

Investigational Product (IP) Self-Administration Training

Finding: The protocol (Section 5.3.1) mandates that after the initial site-administered dose, subjects will self-administer the subcutaneous (SC) investigational product at home for most subsequent doses. While it mentions subjects should be instructed on proper SC injection technique, it lacks specific details regarding the standardized training procedures, required educational materials, method for assessing subject competency in self-injection, and clear documentation requirements for this training. This operational gap could lead to variability in training quality across sites, potentially increasing the risk of administration errors, impacting subject adherence, and affecting the integrity of IP exposure data. Recommendation: To ensure consistency and thoroughness, develop and disseminate a standardized IP Self-Administration Training Pack to all participating sites. This pack should include:

1. A detailed, step-by-step training checklist for site staff (e.g., CRC, study nurse) to follow during the instruction.

2. Standardized, patient-friendly educational materials (e.g., an illustrated brochure, a link to an instructional video if available, and information on storage/disposal).

3. A clear protocol for subjects to perform a return demonstration of the self-injection technique under staff observation to confirm competency.

4. A dedicated section in the source documentation or a specific training log to record the date of training, topics covered, confirmation of return demonstration and competency, and signatures of both the trainer and the trained subject. Clarify if practice injection devices are available and should be utilized during training.

Rationale: Implementing a standardized IP self-administration training program with clear competency assessment and documentation will enhance patient safety by reducing administration errors, improve subject compliance and confidence, ensure consistency in IP administration across all participants and sites, and strengthen the reliability of data related to IP exposure, ultimately contributing to higher quality trial outcomes.