|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Foundations, Ethics, and Law Program|
QA Basic is a toolkit of resources to help small institutions or human research protection programs (HRPPs) develop quality assurance and improvement (QA/QI) activities. QA/QI can be defined as the activities and processes designed to measure and improve the quality, effectiveness, and efficiency of an HRPP and the individual studies it oversees. These activities must comply with organizational policies and procedures, as well as all applicable laws, regulations, codes, and guidance.
QA Basic addresses:
QA Basic is comprised of specially developed resources as well as existing institutional tools and templates compiled by Harvard Catalyst's QA/QI Subcommittee. This toolkit is available for educational and reference purposes; it is not intended to be all-inclusive or to provide legal advice. Please consult with your institutional official or general counsel, as needed.
Harvard Catalyst QA/QI Consulting Service [Request a consult]
Offering consultation to institutions and IRBs that are part of the Harvard Catalyst Master Common Reciprocal Reliance Agreement, or are preparing to join the agreement.
QA/QI Handbook (coming soon)
A comprehensive handbook for designing, developing, staffing, and maintaining an effective QA/QI program. Specific chapters are referenced in the sections below.
Research Study Regulatory Binder Templates:
Below is a list of regulatory binders from institutions that are part of Harvard Catalyst and the Regulatory QA/QI Subcommittee.
Harvard Catalyst Regulatory Binder
A customizable documentation system for tracking, maintaining, and achieving regulatory compliance in biomedical or social-behavioral research. This binder was developed by the Harvard Catalyst Regulatory QA/QI Subcommittee.
Cambridge Health Alliance Regulatory Binders
Boston Children's Hospital Regulatory Binder
Partners HealthCare eReg Binder
The eReg Binder is a REDCap project developed by the Partners Human Research Quality Improvement (QI) Program and Enterprise Research Infrastructure & Services (ERIS). The eReg Binder assists sites with the electronic storage and maintenance of regulatory documents for IRB-approved protocols. The eReg Binder is available through the REDCap consortium.
Investigator Training Materials
FDA IRB Inspections
How to Survive an FDA Inspection (Cynthia Monahan, Partners QI Program - January 7, 2009; revised June 11, 2015) [PDF]
How to Prepare for Federal Inspections and What to Expect (Jennifer Graf, Tufts Medical Center/Tufts University Health Services - February 2011; Revised March 1, 2016) [PDF]
Research Team Self-Assessment Tools
Minimal Risk Study Start-up Checklist [Doc]
This checklist is a tool for researchers conducting minimal risk studies. It may help achieve compliance with federal and state regulations, institutional policies, and good clinical practices (GCP).
Investigator Self-Assessments [instructions] [Examples: 1, 2 [doc], 3 [PDF]]
Participant Files: Investigator Self-Assessment [PDF]
Clinical Research Addendum: Investigator Self-Assessment [PDF]
Consent Compliance Checklist: Investigator Self Assessment [Doc]
Research Study Internal Audit Tools & Templates
Audit Standard Operating Procedures (SOPs) [example - PDF]
For multi-institutional studies where IRB review has been ceded under the Master Reciprocal Common IRB Reliance Agreement, please request the Harvard Catalyst Audit SOP and designated contact list.
Model Audit/Review Tools [Request Audit Tools]
A comprehensive, customizable template for performing audits.
Tracking Logs & Templates
QA/QI Handbook Chapter 3: Investigator Site Review (coming soon)
IRB Review/Audit SOP [Example - PDF]
Internal Study & IRB Audits
Institutional Review Board Meeting Minutes [FDA Draft Guidance]
QA/QI Handbook Chapter 4: Evaluating IRB Compliance (coming soon)
Tracking Logs and Templates
Collaboratively Delivering QA/QI Support, Tools, and Resources by Leveraging Internal and External Expertise: A Harvard Catalyst Model [PDF]
This poster describes the QA/QI Subcommittee and how the group collaborates to develop and support QA/QI
Continuing Quality Improvement: Encouraging the Feedback Loop [PDF]
Boston Children's Hospital implements a process to initiate a 'for-cause' IRB-focused audit, without compromising a PI's confidentiality
The Impact of Submission Assistance on IRB Review Turnaround Time
The Harvard LMA School Quality Improvement Program (QIP) set out to improve IRB submissions to facilitate the IRB review and approval process
Developing Timely & Appealing Human Subject Protection Refresher Education Using Education Program Participation, Unanticipated Problem, & Internal Audit Data [PDF]
Boston Children's Hospital develops timely and appealing content with the goal of increasing site-based refresher course participation
A Solution to Creating and Managing your Regulatory Binder Electronically [PDF]
Partners HealthCare's electronic regulatory binder (eReg binder) template assists sites with the electronic creation, storage, and maintenance of essential documents for IRB approved protocols
Office of Research Administration FOIA Electronic Reading Room (483s)
This is a repository of FDA official communications following audit and inspections which illustrates trends in FDA inspections and findings.
Common Investigator Audit Findings [doc] (nationwide - compiled by Cambridge Health Alliance)
Programs contributing materials and resources: