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Clinical Research Coordinator Analysis

Nasal Endoscopy Video Recording Logistics

Finding: Section 5.3.1.3 mandates video recordings of nasal endoscopies at multiple visits (Screening, Day 1, Week 4, Week 8, Week 12, and Week 16/ET). While the protocol states "The site will be provided with specific instructions and training regarding the video recording procedure," it currently lacks crucial upfront details regarding the technical requirements for recording equipment (if site-provided), standardized procedures for data handling of potentially large video files (including specific format, secure transfer methods, storage expectations, and any de-identification processes required for PHI prior to transfer), and clear quality control parameters for the videos. This ambiguity could lead to inconsistent video quality across sites, significant challenges in integrating the recording process into busy clinic workflows, difficulties with data transfer, and potential for unusable data or protocol deviations if equipment or processes are found to be inadequate only after study activation. Recommendation: Request the Sponsor to develop and provide a comprehensive "Nasal Endoscopy Video Recording Manual" to sites well in advance of the Site Initiation Visit (SIV). This manual should clearly detail:

1. Specific requirements or recommendations for video recording equipment (e.g., endoscope type, camera resolution, light source specifications, recording software/hardware compatibility). If sponsor-provided, details on its operation and integration.

2. A step-by-step Standard Operating Procedure (SOP) for the recording itself, including patient positioning, required anatomical views/landmarks to capture, and duration of recording.

3. Mandatory video file format (e.g., MP4, AVI), minimum resolution, frame rate, and standardized file naming conventions.

4. A validated, secure, and user-friendly method for video file transfer to the central reviewer or CRO, including guidance on handling large files, estimated upload times, and any specific software or platforms to be used.

5. Explicit instructions on any required de-identification of video files to remove Patient Health Information (PHI) before transfer, compliant with privacy regulations.

6. A simple quality control checklist for site staff to use to verify video clarity, completeness, and adherence to requirements before submission.

Furthermore, advocate for a hands-on mock recording session using the designated equipment and process during the SIV to proactively identify and troubleshoot any site-specific technical or workflow issues.

Rationale: Proactively establishing and communicating these detailed procedures and technical requirements will ensure the collection of high-quality, consistent, and centrally evaluable video data, which is critical for primary and secondary endpoint assessments. It will also minimize the risk of protocol deviations related to procedural execution, reduce site burden by allowing for better workflow planning, and help sites prepare adequately for the technical aspects of this key assessment, ultimately streamlining visit conduct and improving data integrity.