Skip To Main Content
Site Name Here
MenuSearchA-ZSeven Schools One UniversitySeven Schools One University

Menu

  • Give
  • Apply
  • Visit
Close Menu
About
  • Administrative Offices
  • Campus Maps
  • Core Values
  • Fast Facts
  • Travel and International Services
  • Other USM Schools
  • Policies and Procedures
  • Strategic Plan
  • Sustainability
  • Middle States
  • MPowering the State
  • News
  • University Leadership
  • UMB Experts Guide
Academics
  • Academic Calendar
  • Academy of Lifelong Learning
  • Blackboard
  • Libraries
  • Office of the Provost
  • SURFS
  • UMB Program Explorer
Admissions
  • Financial Aid
  • International Students
  • Military and Veterans
  • Office of the Registrar
Research
  • Breakthroughs Can’t Wait
  • Offices and Contacts
  • Resources for Investigators
  • Services for Investigators
  • UMB Research Profile
University Life
  • Arts and Culture
  • Bookstore
  • Emergency
  • Housing
  • Museums
  • Parking and Transportation Services
  • Rooms Available on Campus
  • SMC Campus Center
  • Student Organizations
  • Student Policies
  • URecFit and Wellness
  • UMB shuttle
  • Welcome to Baltimore
  • One Card
Info For
  • Current Students
  • Faculty and Staff
  • Alumni and Donors
  • Community Members
Resources
  • The Elm
  • Calendar
  • myUMB
  • Directory
  • Blackboard
  • SURFS
  • Emergency
  • UMB Shuttle
Seven Schools One University

Search

Close Menu
Common Searched Terms
  • Graduation 2025
  • Campus Tour
  • Jobs at UMB
  • Parking
  • Tuition Remission
  • Registrar
  • Qualtrics
  • Human Resources
  • URecFit and Wellness
  • Tuition
  • Help Desk

A–Z

Close Menu
    Human Research Protections

    Past Announcements

    1. UMB Home
    2. About UMB
    3. Administrative Offices
    4. Accountability and Compliance
    5. OAC Services
    6. Research Compliance
    7. Human Research Protections
    8. Past Announcements
    • UMB HomeAbout UMBAdministrative OfficesAccountability and ComplianceOAC ServicesResearch ComplianceHuman Research ProtectionsPast Announcements
    • Key Contacts
    • For Researchers
    • Institutional Review Board (IRB)
    • HRP Office
    • For Research Participants
    • UMB HRP Components

    NIH released a policy on Good Clinical Practice (GCP) Training for NIH Awardees involved in NIH-funded Clinical Trials

    NIH has released a policy on Good Clinical Practice (GCP) Training for NIH Awardees involved in NIH-funded Clinical Trials.       

    This policy went into effect on 1/1/2017.

    NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials are required to be trained in GCP. GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines.  Recipients of GCP training are expected to retain documentation of their training. It is the responsibility of the individual research team member to complete and maintain documentation of this training. Beginning 6/1/2017, NIH-funded clinical trials will be randomly selected to have their study team's GCP training confirmed.

    A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

    Courses that will be accepted at University of Maryland, Baltimore are:

    • CITI Good Clinical Practice and ICH, completed under University of Maryland Baltimore or Baltimore VA affiliation;
    • CITI Good Clinical Practice (US FDA Drug and Device Focus), completed under University of Maryland Baltimore affiliation;
    • CITI GCP - Social and Behavioral Research Best Practices for Clinical Research, completed under University of Maryland Baltimore affiliation;
    • Good Clinical Practice for Social and Behavioral Research eLearning Course;
    • National Drug Abuse Treatment Clinical Trials Network Good Clinical Practice course. This course can be completed by those who conduct NIH funded social-behavioral research even without a drug abuse focus;  OR
    • Other GCP training will be accepted as meeting the requirement if the course is approved by TransCelerate.

    If completing the one of the CITI course options, learners will need to log in to their already existing CITI account (CITIprogram.org) and add the course. The fourth option can be accessed at http://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course. The fifth option can be accessed at https://gcp.nidatraining.org/. Learners will need to create a login account and complete the course. A listing of Transcelerate-approved GCP courses can be located at http://www.transceleratebiopharmainc.com/gcp-training-attestation/#headline4.

    GCP Training Access Instructions

    A link to the NIH policy is provided here:  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

    For questions, please call the University of Maryland Baltimore Human Research Protections Office at 410-706-5037.  Thank you.


    • Back to Past Announcements
    University of Maryland Baltimore

    The University of Maryland, Baltimore is the founding campus of the University System of Maryland.

    620 W. Lexington St., Baltimore, MD
    21201 | 410-706-3100

    • The Elm
    • Calendar
    • Emergency
    • Mobile UMB
    • UMB Shuttle
    • myUMB
    • Directory
    • IT Help Desk
    • Facilities Work Request
    • Jobs
    • Middle States
    • Strategic Plan
    • Sustainability
    • Clery Report
    • UMB Hotline
    • Facebook
    • Twitter
    • Instagram
    • LinkedIn
    • YouTube
    The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination.
    © 2024-2025 University of Maryland, Baltimore. All rights reserved.
    • Privacy Policy
    • Web Accessibility
    • Web Feedback
    • Non-Discrimination