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Guidelines for Temple University researchers on actions to take during FDA or OHRP inspections related to clinical trials, including preparation, documents needed, and communication protocols.
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How to fill out Temple University Institutional Review Board Conduct During FDA and OHRP Inspections: A Guide for Temple Researchers
01
Review the purpose and scope of the guide to understand its relevance.
02
Gather all necessary documentation related to your research project.
03
Prepare a list of key personnel involved in the research and their roles.
04
Familiarize yourself with FDA and OHRP regulations that pertain to your research.
05
Identify all informed consent processes utilized in your study.
06
Ensure that all data management practices comply with ethical standards.
07
Schedule training sessions for team members on inspection readiness.
08
Conduct a mock inspection to identify potential gaps in documentation and compliance.
09
Compile a checklist based on the guide to prepare for the inspection day.
10
Designate a point of contact for the inspection and inform the team.
Who needs Temple University Institutional Review Board Conduct During FDA and OHRP Inspections: A Guide for Temple Researchers?
01
Researchers at Temple University conducting studies involving human subjects.
02
Institutional Review Board members overseeing research projects.
03
Research administrators managing compliance with regulatory standards.
04
Anyone preparing for FDA or OHRP inspections related to human research.
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People Also Ask about
What is a university IRB?
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
How do I contact the IRB at Temple University?
The IRB must have at least five members and include individuals from three specific categories: scientists, administrators, and community members. This diverse composition helps to assess the ethical implications of research proposals from various perspectives.
How do I contact the Penn IRB?
If you require faster assistance, please call the IRB mainline at 215-573-2540. Please note that the IRB does not have time nor resources to provide 1-on-1 walkthroughs of the online submission system. If you need this type of assistance, please sign up for an IRB 101 session.
How do I contact IRB Central?
Phone Numbers: 1-833-931-5121 Hours: Mon-Fri 8 am-4 pm Website: .irb-cisr.gc.ca Address: 25 St Clair Ave E Suite 200 Toronto, ON M4T 0A8 Map Location: Cross street: Yonge St and St Clair Ave E29 more rows • Mar 28, 2025
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What is Temple University Institutional Review Board Conduct During FDA and OHRP Inspections: A Guide for Temple Researchers?
The guide outlines the procedures and expectations for Temple University researchers when undergoing inspections by the FDA and OHRP, ensuring compliance with ethical standards and regulatory requirements.
Who is required to file Temple University Institutional Review Board Conduct During FDA and OHRP Inspections: A Guide for Temple Researchers?
All researchers at Temple University who are conducting studies involving human subjects and are subject to FDA or OHRP regulations are required to file this guide.
How to fill out Temple University Institutional Review Board Conduct During FDA and OHRP Inspections: A Guide for Temple Researchers?
Researchers should complete the guide by detailing their study procedures, submitting necessary documentation, and adhering to the specified timelines for inspections.
What is the purpose of Temple University Institutional Review Board Conduct During FDA and OHRP Inspections: A Guide for Temple Researchers?
The purpose of the guide is to facilitate compliance with federal regulations, protect human subjects, and provide clear instructions for researchers during inspections.
What information must be reported on Temple University Institutional Review Board Conduct During FDA and OHRP Inspections: A Guide for Temple Researchers?
Researchers must report information regarding study protocols, informed consent processes, adverse events, and any deviations from the approved research plan.
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