Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

ICR 201512-0910-008

OMB: 0910-0733

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-01-04
IC Document Collections
IC ID
Document
Title
Status
204492 Modified
ICR Details
0910-0733 201512-0910-008
Historical Active 201210-0910-002
HHS/FDA CDER
Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
Extension without change of a currently approved collection   No
Regular
Approved without change 06/20/2016
Retrieve Notice of Action (NOA) 01/06/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 06/30/2016
132 0 132
528 0 528
0 0 0

The guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The guidance makes clear that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring investigator conduct and performance in investigational new drug (IND) studies conducted under 21 CFR part 312 or investigational device exemption (IDE) studies conducted under 21 CFR part 812. The guidance describes strategies for monitoring activities performed by a sponsor, or contract research organizations (CROs), that focus on the conduct, oversight, and reporting of findings of an investigation by clinical investigators. The guidance recommends strategies that reflect a risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. For example, the guidance specifically encourages greater reliance on centralized monitoring methods, where appropriate.

US Code: 21 USC 505(b)(1) Name of Law: The Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 41044 07/14/2015
80 FR 78745 12/17/2015
Yes

1
IC Title Form No. Form Name
Development of Comprehensive Monitoring Plan

  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 132 132 0 0 0 0
Annual Time Burden (Hours) 528 528 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
01/06/2016


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