Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
DMC Meeting Records New 370 740 0 Other-Guidance
DMC reports of meeting minutes to the sponsor New 740 740 0 Other-Guidance
SOPs for DMCs New 37 296 0 Other-Guidance
Sponsor notification to the DMC regarding waivers New 1 0 0 Other-Guidance
Sponsor reporting to FDA on DMC recommendations Modified 37 19 0 Other-pdf
Total burden requested under this ICR: 1185 1795 0  
To view an IC, click on IC Title