HSPP Quality Assurance and Quality Improvement (QA/QI) Program

The aim of the HSPP QA/QI Program is to enhance the quality of research and protection of human subjects through continuous process improvement. The QA/QI Program performs auditing and provides education to enhance understanding of best practices for study conduct and issues related to the ethical conduct of human research and the protection of human subjects.

  • HSPP Quality Assurance Planning
  • Quality Indicator Report
  • Self-Assessment Toolkit
  • Site Initiation Logs
  • Educational Materials

The Human Subjects Protection Program Quality Assurance includes documents that have been developed to prepare the study team for site visits and audits. These can be categorized under the following headings:

  1. Quality Assurance Education, Training and Consultation. This document will prepare investigators for study initiation and study closeout visits. The document will also provide a list of the topics that are discussed with new research staff members during a consultation.
  2. Quality Assurance Auditing and Monitoring. This document explains what types of studies require monitoring.
  3. Study Initiation Visit and Orientation FAQs. This document addresses frequently asked questions about study initiation visits and the quality assurance orientation.
  4. Quality Assurance Self-Audit. This document discusses the goals and components of the quality assurance self-audit. A description of the logs that are used to audit clinical research is provided to help investigators train in self-auditing.
  5. Audit FAQs. This document reviews frequently asked questions about audits.
  6. Monitoring FAQs. This document reviews frequently asked questions about monitoring.
  7. Monitoring Needs Questionnaire. This checklist will help the Principal Investigator assess the need for additional monitoring of a sponsored study. 
  8. Research Organization Monitoring Profile. This checklist is filled out by the Principal Investigator to request additional monitoring.

The Quality Indicator Report document lists the regulatory elements that will be evaluated by the auditor during an audit.

The self-assessment toolkit consists of documents that will help the research team navigate through the informed consent process and the reporting of serious adverse events. These can be categorized under the following headings:

  1. Audit Tool for Minimal Risk Research. This document is a checklist of the forms and materials that the auditor will review during an audit.
  2. Audit Tool for More Than Minimal Risk Research. This document is a checklist to allow investigators to conduct a quality self-assessment.
  3. Informed Consent Audit Tool. This document is a checklist of information that must be acquired from specific individuals when completing consent/assent forms.
  4. Informed Consent Process Note. This document provides a framework for documenting the consent process.

The site initiation logs are used for clinical studies to provide a structure for the documentation of study related data.

Documents developed for the purpose of providing instructional material. These can be categorized under the following headings:

  1. Notes to the Informed Consent. Will provide information to the research team with regard to documenting the consent process.
  2. Short Form FAQs. Reviews frequently asked questions about the short form consent document.
  3. Lessons from FDA Audits at CHLA: Regulatory Documents. Provides information regarding FDA audits.
  4. Lessons from FDA Audits at CHLA: Logs. Provides information about the study audit.
  5. Role of the Data Safety Monitoring Board. Describes the role of the Data Safety Monitoring Board in overseeing clinical studies.
  6. Developing a Serious Adverse Event Reporting Plan. Describes where to download the Research Monitoring Plan worksheet and how to file serious adverse events.