[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25281-25282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0001]


Improving the Implementation of Risk-Based Monitoring Approaches 
of Clinical Investigations; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA, we) is announcing the 
following pubic workshop entitled ``Improving the Implementation of 
Risk-Based Monitoring Approaches of Clinical Investigations.'' This 
public workshop is convened by Duke University's Robert J. Margolis, 
MD, Center for Health Policy and supported by a cooperative agreement 
with FDA. The purpose of the public workshop is to capture stakeholder 
experiences with risk-based approaches to monitoring of clinical 
investigations and gather stakeholder input on opportunities to further 
the implementation of risk-based approaches to monitoring.

DATES: The public workshop will be held on July 17, 2019, from 8:30 
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at the Marriott Marquis 
Washington, DC at 901 Massachusetts Ave. NW, in Washington DC. For 
additional travel and hotel information, please refer to the following 
website: https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-trials. There will also be a 
live webcast for those unable to attend the meeting in person (see 
Streaming Webcast of the Public Workshop).

FOR FURTHER INFORMATION CONTACT: Raymond Chiang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2232, Silver Spring, MD 20993, 301-796-
1940, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    To support greater implementation of risk-based approaches to 
monitoring (RBM) of clinical investigations, FDA issued draft guidance 
for industry in March 15, 2019 (84 FR 9531) entitled ``A Risk-Based 
Approach to Monitoring of Clinical Investigations: Questions and 
Answers, `` which is available at https://www.fda.gov/media/121479/download. This draft guidance expands on the guidance for industry 
entitled, ``Oversight of Clinical Investigations--A Risk-Based Approach 
to Monitoring'' (August 2013) by providing additional guidance to 
facilitate sponsors' implementation of risk-based monitoring.
    Traditionally, sponsors and research organizations have depended 
upon on-site monitoring and 100 percent source data verification for 
each clinical site, an approach that is resource intensive and may 
contribute to increased clinical trial costs. Adoption of RBM could 
lead to improvements to human subject protections, data integrity, and 
the efficiency of clinical investigations.
    Data suggest that RBM has not yet been widely implemented. 
Therefore, FDA is seeking additional feedback from stakeholders on the 
challenges, barriers, and enablers that might be impacting the adoption 
of RBM. The public workshop addressed in this document is being held to 
capture stakeholder experiences with risk-based approaches to 
monitoring of clinical investigations and to gather stakeholder input 
on ways to improve the implementation of risk-based approaches to 
monitoring.

II. Topics for Discussion at the Public Workshop

    During the public workshop, speakers and participants will cover a 
range of issues related to implementation of risk-based approaches to 
monitoring. Topics for discussion will include, and are not limited to, 
challenges to implementation of RBM, enablers to support implementation 
of RBM, and lessons learned from strategies employed to implement RBM.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, complete the 
registration form at https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-trials. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register online by July 16, 2019, by 5 p.m. Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
registered. If time and space permit, onsite registration on the day of 
the public workshop will be provided beginning at 8 a.m. We will let 
registrants know if registration closes before the day of the public 
workshop.
    If you need special accommodations due to a disability, please 
contact the Duke-Margolis Center for Health Policy (phone: 202-791-
9561, email: [email protected]) no later than July 10, 2019.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast and archived video footage will be available at the 
event website. Persons interested in viewing the live webcast are 
encouraged to register in advance (see Registration). The live webcast 
will also be available at the website above on the day of the event 
without preregistration. Registered webcast participants will be sent 
technical system requirements in advance of the event. It is 
recommended that you review these technical system requirements prior 
to joining the streaming webcast of the public workshop.
    FDA has verified the website addresses in this document, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.
    Meeting Materials: All event materials will be provided to 
registered attendees via email prior to the workshop and will be 
publicly available at the Duke-Margolis Center for Health Policy 
website: https://healthpolicy.duke.edu/

[[Page 25282]]

events/improving-implementation-risk-based-monitoring-approaches-
clinical-trials.
    Transcripts: Please be advised that transcripts of the public 
workshop will not be available.

    Dated: May 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11411 Filed 5-30-19; 8:45 am]
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