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Initiate regulatory tasks

Information:

  • All Partners-affiliated investigators must obtain Partners Human Research Committee (PHRC – the Partners IRB) approval prior to initiation of a clinical research study. Insight is the program used at Partners to manage IRB submissions. Submit your protocol to the IRB early to ensure that you have ample time to respond to their feedback before receiving approval and initiating your study.
  • The Partners Human Research Quality Improvement (QI) Program provides a virtual Regulatory Binder and consultations to help investigators and study staff achieve and maintain regulatory compliance and ensure the highest standards of human subject research.
  • Seek support from the PHRC and QI for guidance on how to prepare and submit Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) applications to the FDA.
  • ClinicalTrials.gov, developed by the National Insitutes of Health/ National Library of Medicine, is a searchable database of information about current ongoing clinical research studies for the medical community and the public. Federal regulations require that investigators for Applicable Clinical Trials register their studies within 21 days of the first subject being enrolled. Applicable Clinical Trials are defined as Trials of Drugs and Biologics (controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation); or Trials of Devices (controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric postmarket surveillance studies). The Partners QI Program is a resource for providing guidance and assistance with this process. The International Committee of Medical Journal Editors (ICJME) requires that investigators register their studies in ClinicalTrials.gov prior to enrolling subjects in order to publish study results.
  • The International Committee of Medical Journal Editors (ICJME), a group of general medical journal editors, require registration of studies in ClinicalTrials.gov as a condition of consideration for publishing research results in their journals. ICJME requires registration of any prospective study assigning an intervention or comparison or control group that looks at a health outcome. The Partners QI Program can provide information on how to enter study information in this website.

Resources:

ClinicalTrials.gov
Clinical Trials Registration: A Resource For Partners Investigators
Food and Drug Administration Amendments Act of 2007 (FDAAA) general requirements for clinical trial registration and reporting
ICJME Registration Requirements
MGH Clinical Research Program IRB Submission/Ongoing Support
▪ Partners Human Research Affairs FDAAA Clinical Trials Registration and Reporting Policy
Partners Human Research Committee (PHRC)
Partners Human Research Quality Improvement (QI) Program
Partners IRB Clinical Trials Registration Guidance
Partners IRB Help Line Mailbox
U.S. Food and Drug Administration (FDA)

Courses:

ONLINE:
Good Clinical Practice and Study Management Basics
IRB HIPAA Training
Meet the Protocol Administrators and Managers of the Partners Human Research Office
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
ClinicalTrials.gov: Does Your Study Need Results Reporting?
ClinicalTrials.gov: Registration
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
IND/IDEs: Beyond the Basics of Investigational Product Applications
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 IV: Part I: Consent Form Writing
IRB Issues for the Bench and Desk Scientist
Maintaining Research Subject Privacy and Information Security
Medical Device Development (Harvard Catalyst)
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.