Generate an IRB Application amendments checklist for expedited review of AI-based cognitive de-identification algorithms in neurological imaging datasets

Generate generate an irb application amendments checklist for expedited review of ai-based cognitive de-identification algorithms in neurological imaging datasets for Scientific Research and Development Services industry

Scientific Research and Development Services

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Upload the full currently-approved IRB submission package including consent forms, protocol, data-use agreement, AI model documentation
Select the category of change requested for expedited review under 45 CFR 46
Indicate the FDA SaMD risk tier or equivalent classification for the updated algorithm
Detail the specific parameters for the updated AI de-identification process including PHI removal threshold, perturbation techniques, and re-identification risk metrics
Select which clinical or research-relevant variables must be preserved during de-identification
Identify which regulatory frameworks and standards the amendment must satisfy
Identify which institutional offices must review or approve this amendment beyond the IRB
Specify your required turnaround time for this expedited amendment based on grant deadlines or publication schedules

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Provide an example of 3-5 fully processed cases demonstrating the updated de-identification quality and utility preservation
Provide any special considerations, timeline conflicts, anticipated delays, or collaboration details that IRB reviewers should know