Sponsor reporting to FDA on DMC recommendations

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

OMB: 0910-0581

IC ID: 6304

Documents and Forms
Document Name
Document Type
Other-pdf
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Sponsor reporting to FDA on DMC recommendations
 
No Modified
 
Voluntary
 

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

Health Consumer Health and Safety

 

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 -1,111 0 1,148
Annual IC Time Burden (Hours) 19 0 0 -1,776 0 1,795
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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