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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201809-0910-002 · OMB 0910-0581 · Active

Forms and Documents
DocumentTypeStatusAvailability
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC IDCollectionTypeStatusForm
6304 Sponsor Reporting to FDA on DMC Recommendations Unchanged
203249 DMC reports of meeting minutes to the sponsor Unchanged
203248 Sponsor notification to the DMC regarding waivers Unchanged
203247 DMC Meeting Records Unchanged
203246 Standard Operating Procuedres for Data Monitoring Committees Unchanged
ICR Details
0910-0581 201809-0910-002
Historical Active 201509-0910-004
HHS/FDA CBER
GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees
Extension without change of a currently approved collection   No
Regular
Approved without change 10/15/2018
Retrieve Notice of Action (NOA) 09/13/2018
  Inventory as of this Action Requested Previously Approved
10/31/2021 36 Months From Approved 12/31/2018
1,185 0 1,185
1,795 0 1,795
0 0 0
This information collection supports the Food and Drug Administration guidance document entitled, “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.” The guidance is intended to assist sponsors of clinical trials in determining when a Data Monitoring Committee (DMC) is needed for monitoring a study and how such committees should operate.
None
None
Not associated with rulemaking
Other Documents for OIRA Review
  83 FR 25015 05/31/2018
83 FR 46164 09/12/2018
No
  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1,185 1,185 0 0 0 0
Annual Time Burden (Hours) 1,795 1,795 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$31,080
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]
  No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
09/13/2018