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Learn about regulatory requirements

Information:

  • Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. GCP standards for conducting human studies are detailed in the International Conference on Harmonization (ICH) GCP Guidelines which incorporate U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations governing human research studies.
  • The principal investigator (PI) is responsible for the conduct of human subjects research in accordance with the investigational plan and all applicable regulations. The PI may delegate duties to co-investigators and other members of the study team, but cannot delegate his/her responsibilities.
  • FDA regulations apply to all studies involving agents regulated by the FDA. HHS regulations apply to behavioral, observational and social science studies which do not involve FDA regulated agents.
  • The Partners Human Research Committee (PHRC) commonly referred to as the Institutional Review Board or IRB, ensures the protection of human subjects in all clinical research projects. All Partners-affiliated investigators must obtain PHRC approval prior to initiation of a clinical research study. Investigators conducting studies involving FDA approved agents being evaluated for unapproved indications or involving unapproved route of administration, doses, etc. may be required to complete the FDA’s Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application.

Resources:

Federal Regulations
Harvard Catalyst Regulatory Knowledge and Support Program
HHS Protection of Human Subjects (45 CFR 46)
International Conference of Harmonization (ICH) Good Clinical Practice (E6) Guidelines
Partners Human Research Committee (IRB) website
Partners IRB Help Line Mailbox
Partners QI Program
US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) Approval Process
US Food and Drug Administration (FDA) Investigational New Drug (IND) Application

Courses:

ONLINE:
▪ Good Clinical Practice and Study Management Basics
▪ HIPAA training via HealthStream [search 'PHE HIPAA']
Submitting your Medical Records/Health Information Research Protocol to the IRB

LIVE TRAINING:
A Hands-On Introduction to eIRB
A Potpourri of FDA Related Issues
▪ CRP Spotlight Series: Managing and Reporting Unanticipated Problems Including Adverse Events
Ethics and Clinical Research Protocols
FDA Inspections, 483's and Warning Letters: How to Avoid and Survive Them
Genetics and Clinical Research: Points to Consider
Good Clinical Practice in Research at an Academic Research Institution
Guidance for Obtaining Surrogate Consent
IND/IDEs: Beyond the Basics of Investigational Product Applications
Introduction to Survey Design
IRB and QI Roundtable Series: Session I: Part I: New Submissions: Initial Full Board Review
IRB and QI Roundtable Series: Session I: Part II: New Submissions
IRB and QI Roundtable Series: Session II: Part I: Continuing Review and Amendments
IRB and QI Roundtable Series: Session II: Part II: Source Documentation
IRB and QI Roundtable Series: Session III: Part I: Amendments and Reporting to the IRB
IRB and QI Roundtable Series: Session III: Part II: Protocol Adherence and Reporting Requirements
IRB and QI Roundtable Series: Session IV: Part I: Consent Form Writing
IRB and QI Roundtable Series: Session IV: Part II: Informed Consent Process
IRB Issues for the Bench and Desk Scientist
Maintaining Research Subject Privacy and Information Security
Medical Device Development (Harvard Catalyst)
Meet the Protocol Administrators and Managers of the Partners Human Research Office
Reporting Results: Should Subjects Be Told Clinical Research Results?
Research Misconduct
What Constitutes a Minimal Risk Study?
What Does the IRB Really Want? How to Write a Human Studies Protocol
Who Tells the IRB What to Do?: The Effects of Case Law on Research Regulations and Oversight

Please click here for a list of CRP current offerings. Many of the CRP's courses are recorded, click here to access our recordings and handouts.