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Clinical Research Coordinator Analysis

Scalp Photography Procedures and Training

Finding: The protocol mandates standardized scalp photography by "trained site personnel" with images sent to a central reader (Section 8.5.1). While training is mentioned as being provided, the practical aspects such as equipment specifications (e.g., camera type, lighting, positioning aids), the process for initial and ongoing training/certification (especially with staff turnover), and detailed quality control measures for image acquisition and submission are not detailed. This lack of upfront detail can lead to delays in site readiness, inconsistent data collection critical for efficacy endpoints, and an increased burden of queries from the central reader. Recommendation: Request the Sponsor/CRO to provide a comprehensive "Scalp Photography Manual" and a detailed training plan well in advance of site initiation, ideally before the Site Initiation Visit (SIV). This manual should clearly outline:

1. Specific equipment requirements (e.g., designated camera models, lenses, lighting kits, backdrops, chin rests/positioning aids) and explicitly state whether this equipment will be sponsor-provided or if sites are expected to procure it.

2. A structured training program, including access to training modules (e.g., web-based, video demonstrations), requirements for certification of personnel, and procedures for training new or back-up staff to ensure continuity.

3. Detailed, step-by-step photographic instructions covering patient preparation, standardized poses/views required, optimal camera settings, and consistent environmental conditions (e.g., room setup, lighting).

4. A gallery of acceptable and unacceptable image examples, highlighting common errors to avoid.

5. Clear procedures for image de-identification, labeling conventions, secure electronic transfer/upload to the central reading facility, and a defined workflow for query resolution related to image quality or completeness.

Rationale: Proactive provision of these detailed materials and a clear training pathway will enable sites to adequately prepare dedicated space, acquire or set up necessary equipment, ensure staff are competently trained before enrolling the first participant, and consistently collect high-quality, standardized photographic data. This is crucial for the integrity of this key efficacy endpoint, minimizing site burden from image rejections and queries, and facilitating timely and accurate central review.