SOPs for DMCs

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

OMB: 0910-0581

IC ID: 203246

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

View Information Collection (IC)

SOPs for DMCs
 
No New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance 0581 Guidance for CT Sponsors 4-4-12.pdf Yes No Paper Only

Health Health Care Services

 

37 0
   
Private Sector Businesses or other for-profits
 
   0 %

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

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