Standard Operating Procuedres for Data Monitoring Committees

Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

OMB: 0910-0581

IC ID: 203246

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Document Name
Document Type
Other-Guidance
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Standard Operating Procuedres for Data Monitoring Committees CBER
 
No Modified
 
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
Other-Guidance FINAL GUIDANCE 0581 9-17-15.Pdf Yes No Paper Only

Health Health Care Services

 

37 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 37 0 0 0 0 37
Annual IC Time Burden (Hours) 296 0 0 0 0 296
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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