Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Quality Assurance (QA) Basic

Overview

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:

  • Investigator and research staff education
  • Staffing and resources
  • Tracking and evaluation of services offered

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.

Resources

Designing a QA/QI Program

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.

Education & Tools for the Research Team

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.

Harvard Longwood Medical Area Schools Regulatory Binders

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.

  • If you are interested in using the binder, please contact the REDCap Administrator at your institution to find out if the template is available for use.
  • If you are a REDCap Administrator interested in adding the template to your environment, full instructions are available. For additional information, please contact EDC Support.

Investigator Training Materials

  • New Investigators [PDF]
    This handout is designed as a guide for QA/QI staff to use when conducting in-person training sessions with new investigators. It includes prompts for topics to cover such as responsibilities, study documentation, organization, storage, training and resources, and support services.

Sponsor-Investigators

  • IND holders [PDF]
    This customizable handout is designed as a guide for training sponsor-investigators who hold INDs. It provides information about responsibilities and how sponsor-investigators should satisfy those responsibilities.
  • IDE holders [PDF]
    This customizable handout is designed as a guide for training sponsor-investigators who hold IDEs. It provides information about responsibilities and how sponsor-investigators should satisfy those responsibilities.
  • Significant Risk or Non-Significant Risk Device [PDF] Determinations
    This handout describes the types of risk determinations for devices and identifies the individuals who make these determinations, the process for following determinations, and the responsibilities of sponsor-investigators.
  • FDA Sponsor and Investigator Responsibility Checklist [PDF]
    This checklist outlines sponsor-investigator responsibilities and provides information about documentation on fulfilling those responsibilities.

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]

The Research Study: Internal Audits & QA/QI

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)

The IRB: Internal Audits & QA/QI

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

HRPP Case Examples - Poster Presentations

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