Initiate regulatory tasks
- 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 Institutes 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” (ICMJE) is a group of medical journals working together to improve the quality of medical science and its reporting. Click here for more information about ICMJE Membership.
- ICMJE requires registration of certain research studies to be considered for publication.
- ICMJE requires registration for any research study that prospectively assigns human participants to one or more health-related interventions to evaluate the effects on health outcomes. For more information about clinical trials registration requirements click here.
- ICMJE requires that research studies are registered on a public database such as ClinicalTrials.gov before the first subject is enrolled.
- NOTE: Several non-ICMJE journals follow this requirement as well.
- It is the Principal Investigator’s responsibility to determine if their research study requires registration due to ICMJE.
- Timing of Registration is important. For ICMJE, you must register before the first subject is enrolled.
- You are not registered on ClinicalTrials.gov until your registration has passed the ClinicalTrials.gov QA review AND you have received an NCT#. Until you have an NCT#, you are not registered!
- If you are unsure if the journal you hope to publish in follows the ICMJE registration requirements, contact the journal directly to inquire about its policy.
- The ClinicalTrials.gov database can be used for both ICMJE and FDAAA requirements. You only have to register once to cover both requirements.
▪ 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
▪ ICMJE Clinical Trial Registration Policy: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
▪ ICMJE Clinical Trial Registration FAQs: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
▪ Local Contacts (ClinicalTrials.gov PRS Administrators):
▪ Sarah White: firstname.lastname@example.org
▪ Emily Ouellette: email@example.com
▪ Shifat Ahmed: firstname.lastname@example.org
▪ 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)
▪ Good Clinical Practice and Study Management Basics
▪ Meet the Protocol Administrators and Managers of the Partners Human Research Office
▪ Submitting your Medical Records/Health Information Research Protocol to the IRB
▪ 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