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Clinical Research Coordinator Analysis

Investigational Product Administration Training

Finding: The protocol (Section 6.2.1, page 32) mandates subject training for at-home subcutaneous self-administration of the Investigational Product (IP), including demonstration of satisfactory technique by the subject prior to self-administering at home. However, the protocol lacks specific details on the minimum content of this training, standardized objective criteria for assessing "satisfactory technique," and the precise documentation required to confirm training completion and competency. This ambiguity presents a risk of inconsistent training quality across different site staff or between sites, potentially leading to subject errors in IP administration at home (impacting safety and data integrity) and insufficient or non-standardized documentation of this critical procedure. Recommendation: To ensure uniformity and thoroughness, it is recommended that the Sponsor develop and provide all sites with a standardized "IP Self-Administration Training Checklist and Competency Assessment Form." This form should outline key training topics (e.g., IP storage at home, syringe preparation, aseptic technique, rotation of injection sites, correct subcutaneous injection technique, observation for and management of common injection site reactions, procedure for missed doses, and proper disposal of used pre-filled syringes). It should also include clear, observable criteria for assessing "satisfactory technique" (e.g., subject correctly verbalizes steps, subject performs a return demonstration on a model or self with saline placebo under supervision). The completed and signed form, attesting to the subject's competency, should be specified as a required source document to be filed in the subject's records and/or Investigator Site File (ISF). Rationale: Implementing a standardized training checklist and competency assessment will ensure all participants receive consistent and comprehensive instruction, enhancing patient safety by minimizing the risk of IP administration errors at home. It will also improve compliance with the prescribed dosing regimen, strengthen data reliability, and provide robust, uniform documentation for monitoring and audit purposes, thereby reducing the risk of protocol deviations related to IP administration.