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Clinical Research Coordinator Analysis

Vineland-II Administration & Staff Qualification

Finding: The protocol specifies that the Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) must be administered by a "trained and qualified interviewer" (Section 8.2.4, p.49). While Section 8 (p.23) mentions "Appropriate training will be provided to site staff on all study assessments, as needed," this phrasing creates ambiguity regarding the specific qualifications or certifications required for Vineland-II administration, the process for obtaining such qualifications if not already held by site staff (e.g., who provides/pays for it, timeline), and whether existing site certifications meet sponsor requirements. This lack of upfront clarity could lead to delays in site readiness, inconsistent assessment administration if standards are not uniformly understood, or difficulty in identifying/allocating appropriately skilled personnel, particularly as the protocol also recommends the *same* interviewer conduct the interview at all visits if possible. Recommendation: Proactively request detailed clarification from the Sponsor/CRO regarding:

1. The specific training, certification, or qualification criteria required for personnel administering the Vineland-II.

2. The plan for providing this training (e.g., centralized sponsor-led training, acceptance of existing certifications with evidence, train-the-trainer model, or provision of training materials for self-certification).

3. The expected timeline for staff to meet these qualifications prior to enrolling the first participant.

Sites should concurrently identify potential staff members who may have relevant experience or qualifications and communicate this to the sponsor to facilitate efficient planning.

Rationale: Clarifying these requirements early ensures that assessments critical to endpoint data are conducted by appropriately qualified personnel, thereby safeguarding data integrity and quality. It also allows sites to plan resource allocation effectively, preventing potential delays in study start-up or conduct due to a lack of adequately trained staff for this specialized assessment.