SYSTEM OUTAGE: Lurie Children’s continues to respond to a cybersecurity matter. During this time, Stanley Manne Children’s Research Institute continues to conduct research, including recruiting and accepting research participants, collecting data, conducting research procedures, and maintaining research operations. Questions about participation in research, or research in general, may be sent to firstname.lastname@example.org.
PAM program was established to ensure that all research with human participants conducted at Lurie Children’s upholds the highest level of protections and is compliant with all applicable laws, rules, and regulations.
The PAM program also aims to:
- Identify potential areas that need improvement, correction, or targeted education.
- Provide hands-on, one-on-one review and monitoring of the implementation of research; and
- Create an open dialogue to promote education and sharing of best practices throughout the research program at Lurie Children’s.
All research at Lurie Children’s is subject to PAM review and research study records are evaluated on a regular basis by ORIC staff. For more information on the PAM process, please see the additional resources listed below.
- Overview of the Human Subjects Research PAM Program: This document explains what to expect during a PAM review.
- PAM Program Checklists: The PAM review team utilizes three checklists during the review of study records.
- Informed Consent Checklist: this checklist is used to ensure proper consent execution and consent procedures.
- Documentation of Informed Consent Checklist: this checklist is used to ensure proper documentation of informed consent process and elements to be included in the consent process documentation.
- Regulatory Binders Checklist: this checklist is used to ensure regulatory files/binders include all the proper documentation.
Additional Resources for monitoring and inspections:
- Clinical Study Audit Checklist
- FDA Inspection Initial Contact Form
- Tips for Preparing for an FDA Inspection
For questions regarding the PAM Program:
The Research Guidance Documents referenced on this page are to serve as a reputable resource for clinical and social behavioral Research Professionals (RP), Principal Investigators (PI), Sub-Investigators (SI) and others on the research team such as Nurses, students/trainees, and contracted staff at Lurie Children's.
The documents provide best practices and the current thinking on specific research topics. They are intended to complement existing Institutional Policies and Procedures and/or Department/Division's Policies (or SOPs). Written and developed by RPs in partnership with Research Leadership, study teams are encouraged to read and follow these guidelines when conducting human subjects research at Lurie Children's.
What are Research Guidance Documents and how do they differ from Standard Operation Procedures (SOP's)?
These documents are written processes or steps to help guide study teams to perform a task the same way each time it is completed. SOP's are "detailed, written instructions to achieve uniformity of the performance of a specific function (ICH GCP 1.55)".
These documents are intended to provide guidance, so adoption is optional, although highly encouraged.
What are the benefits of following these Research Guidance Documents?
- Assist in attaining and maintaining compliance with Federal Regulations, International Conference on Harmonization Good Clinical Practice Guidelines, and Lurie Children's procedures and policies;
- Protect the rights and welfare of human study participants;
- Improve the quality and integrity of research conduct;
- Provide as a reference tool with steps for conducting research; and
- Serve as a training tool and resource for new and existing study team members.
Questions related to applying these guidelines within your research team may be addressed to the Office of Research Integrity and Compliance (ORIC) team ResearchCompliance@luriechildrens.org.
Regulatory Binder Templates, Logs, and Resources
Table of Contents Templates
Binder Tab Templates
FDA Templates/Resources Studies
- FDA 1572 FAQ Document
- TransCelerate 1572 Guidance Document
- FDA Document & Correspondence History
- FDA Medical Devices FAQ Document
All human subject research studies
- Regulatory Binder Cover
- Delegation of Authority (DoA) Log
- Training Log
- CITI Training Tracker Log
- Enrollment Log
- Screening/Recruitment Log
- Informed Consent Version Log
- IRB Submission Tracking Log
- Monitoring Visit Log
- Protocol Deviation/Violation Log
- Protocol Version Tracking Log
- Specimen Tracking Log
- Investigational Device Accountability
Notes to File Templates
- Note to File - Template
- Note to File - Cayuse
- Note to File - Investigational Product Accountability/Shipping Records
Participant Binder Logs and Checklists