Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Good Clinical Practice
or 'GCP' training for investigators and study-team members is increasingly
becoming required by institutions, sponsors, and the NIH. This 90 minute
course will explain the elements of the International Conference for
Harmonization's (ICH) principles and specific guidelines for Good Clinical
Practice. Attendees will be introduced to the GCP Principles, and will
explore investigator responsibilities in human subject research, focusing
on the areas of trial conduct (experience, resources, and physician
duties); performance (communication with the IRB, protocol compliance,
and investigational product management); ethical research (safety oversight
and informed consent); and recording/reporting (data acquisition, progress
summaries, and safety-event reporting).
These training sessions are held the fourth Friday
of each month. Register here: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728
Effective November 1, 2017 we are making changes to streamline the number of FWAs held by the institution and ensure that each legal entity has one FWA. This change will require closing out some existing FWAs assigned to organizations that are components under either the Johns Hopkins School of Medicine FWA number or The Johns Hopkins Health System FWA number. Functionally nothing else regarding IRB review or our human research protections program will change. However, organizational components should please take note of the new FWA that will be affiliated with each component and ensure only the two FWAs listed below are referenced moving forward.
FWA Numbers & Components:
The Johns Hopkins University School of
The Johns Hopkins Hospital and Johns
Hopkins Health Systems [FWA00006087]
The following separate FWAs should
no longer be referenced as of November 1, 2017:
For additional questions about FWAs please visit:
For questions regarding the changes to our
existing FWAs, please contact Megan Kasimatis Singleton, Assistant Dean
for Human Research Protection at firstname.lastname@example.org
or (443) 287-0204.
If you are conducting NIH-funded research that
involves human subjects, or are considering applying to NIH for support
of such research, please note important changes that may affect how
First, familiarize yourself with the new PHS
Human Subject and Clinical Trial Information form. For application
due dates of January 25, 2018, and beyond, you will be required to use
an updated application forms package (FORMS-E), which includes the new
human subject and clinical trial form. This form requests human subject
and clinical trials information at the study level using discrete form
fields, which is a change from current practice. Contract proposals
will also require this information. Learn
about the new form here.
Second, take a moment
to answer these four questions about your current or proposed research:
If the answer to all
four questions is yes, then your proposed research meets the NIH
definition of a clinical trial. Clarified and broadened in 2014,
the definition encompasses a wide range of trial types: mechanistic,
exploratory/developmental, pilot/feasibility, behavioral, and more.
NIH expanded the clinical trial definition in response to widespread
calls from diverse stakeholders for improved reporting of research milestones
and outcomes, and for assuring maximal transparency.
Need help determining
whether your study would be considered by NIH to be a clinical trial?
See the NIH webpage
on the definition that includes case studies, FAQs and other resources
that can help. Still unsure? Contact your NIH program official or the
scientific point of contact listed on the funding opportunity announcement
to which you are applying.
yourself with NIH policy changes related to enhancing stewardship of
NIH made a number of
policy changes to improve the stewardship of clinical trials across
the life cycle of the trial. Familiarize yourself with all that is changing,
Improving the design,
efficiency, and transparency of clinical trials is important because
The NIH has developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know.
Please review this information carefully.
Your attention to detail will be critical to ensuring successful funding
of your clinical trial awards.
A Department of Medicine faculty member is a PI
on a large NHLBI R24 "national infrastructure" grant. This
NIH grant aims to provide resources for longitudinal clinical research
studies. The following resources are freely available from the project's
Effective September 25, 2017, the NIH requires
that all grant applications for domestic, multi-site, non-exempt human
subject research studies include a proposal for the use of a single
IRB ("sIRB") to review the research for all participating
domestic sites. The JHSPH IRB, the SOM IRB, and the Homewood IRB are
working together to address the new NIH requirement for sIRB. When sIRB
services are required by a Sponsor, and a JHU PI wants JHU to serve
as the study's sIRB, the SOM IRB will review all requests for
sIRB services, and if approved, will serve as the University's sIRB
for all divisions. JHU has signed on to the SMART IRB Reliance
agreement, and investigators are urged to make sure that their collaborators
have either signed on to this form of reliance agreement, or are willing
to sign on.
All other reliance requests will be managed
by the IRB associated with the PI's division. Please contact JHMIRBreliance@jhmi.edu
with questions about the SOM IRB sIRB process.
JHM IRB is willing to review requests for reliance on an external IRB as well as requests for JHM to act as the IRB of record. Typically, requests for reliance are submitted to our IRB at two time points:
The first step in the reliance request process
is to complete a reliance
request. The JHM IRB reliance team will review the information provided
in the reliance
request and will contact you with next steps.
For more information about the JHM reliance,
please visit: http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html
A funding partnership among seven prestigious
universities - including the Johns Hopkins Institute for Clinical and
Translational Research - are awarding nearly $300,000 to scientists
working on collaborative research among their institutes that will explore
widely ranging health concerns, from creating tumor-destroying viruses
to decreasing the large numbers of mentally ill in the criminal justice
The Sharing Partnership for Innovative Research
in Translation (SPIRiT) consortium has offered this funding of research
since 2012, awarding more than $1 million to 12 collaboration projects.
The SPIRiT consortium is made up of six National
Institutes of Health (NIH) Clinical and Translational Science Awards
(CTSA) Programs, including the Johns
Hopkins University Institute for Clinical and Translational Research,
of Pennsylvania's Institute for Translational Medicine and Therapeutics,
University of Pittsburgh's Clinical and Translational Science Institute,
in St. Louis' Institute of Clinical and Translational Sciences,
Yale University's Center
for Clinical Investigation, and the
Institute for Translational Medicine (ITM), a partnership between
the University of Chicago and Rush.
For more information on the Johns Hopkins
awardee for this program as well as details on the individual projects,
visit our webpage.
The Johns Hopkins Institute for Clinical
and Translational Research (ICTR) offers many clinical resources for
faculty and student investigators, including outpatient and inpatient
space for studies in clinical research units, patient recruitment tools,
collaboration opportunities, and various tools to protect patient data.
To see all the services offered by the ICTR, visit the
The Johns Hopkins Clinical Research Network (JHCRN)
is an all-in-one resource for linking investigators to regional community-hospital
based collaborators for the success of investigator-initiated and industry
funded studies. Please visit the JHCRN website to learn more about this