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

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.

Quality Indicator Report

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

Self-Assessment Toolkit

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.

Site Initiation Logs

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

• HRP-500 Sponsor Correspondence Log: Allows study team members to monitor sponsor correspondence.
• HRP-501 Eligibility Verification Log: Allows study team members to document individuals who meet inclusion criteria or exclusionary criteria.
• HRP-502 Screening Log: Allows study team members to document the screening process.
• HRP-503 Recruitment Materials Log: Allows study team members to monitor recruitment materials.
• HRP-504 Enrollment Log: Allows study team members to monitor enrolled subjects.
• HRP-505 Informed Consent/Assent Log: Allows study team members to keep a record of legally effective informed consent obtained from individuals.
• HRP-506 Protocol Changes Tracking Log: Tracks changes made to the protocol to ensure that amendments have been submitted and approved by the IRB.
• HRP-507 Protocol Deviation Log: Allows study team members to detect, report and document protocol deviations.
• HRP-508 Serious Adverse Event Log: Allows study team members to detect, report and document a serious adverse event.
• HRP-509 Site Monitoring Log: Tracks the site monitor’s activities during site visits.
• HRP-510 Source Document Log: Allows study team members to substantiate the integrity of study data.
• HRP-511 Delegation of Authority: Records all study staff members’ study-related duties.
• HRP-512 Evidence of Training Log: Documents of human subjects training.
• HRP-513 Investigator Meeting Log: Documents of attendance at research meetings.
• HRP-514 Site Initiation Log: Allows study personnel to document and monitor study initiation visits.
• HRP-515 Lab Sample Shipment Log: Allows study team members to track lab sample shipments.
• HRP-516 Investigator Brochure Log: Allows study team members to document data changes related to the Investigator’s Brochure.
• HRP-517 Drug Accountability Log: Allows study team members to document information related to the study drug.
• HRP-518 Drug/Device Shipment Log: Allows study team members to monitor drug/device shipments.
• HRP-519 Drug Destruction Log: Provides study team members with the appropriate steps in documenting the disposal of unused study drugs.

Educational Materials

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.