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 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.
▪ 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)
▪ 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
▪ 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