DMC reports of meeting minutes to the sponsor

GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

OMB: 0910-0581

IC ID: 203249

Documents and Forms
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no available documents/forms check other ICs listed under this ICR
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DMC reports of meeting minutes to the sponsor CBER
 
No Unchanged
 
Voluntary
 
21 CFR 312.50 21 CFR 312.56 21 CFR 812.40 21 CFR 812.46

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Health Care Services

 

370 0
   
Private Sector Businesses or other for-profits
 
   25 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 740 0 0 0 0 740
Annual IC Time Burden (Hours) 740 0 0 0 0 740
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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