Clinical Trials Reference Materials and Related Links

Tutorials (or Education)

• NIH Protecting Human Research Participants 
• OHRP Human Subject Assurance Training
• DHHS/NIH Human Participant Protections Tutorial for Researchers 
• Human Subjects Protections Training
• NIH Policy on Required Education in the Protection of Human Research Participants

Guidelines

• DHHS Office for Human Research Protections: IRB Registration and Assurances/Declaration of Exemption (Common Rule)
• NIH Certificates of Confidentiality Template

• FDA Clinical Trials and Human Subject Protection - An overview of the FDA standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
• Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards (IRBs)
• FDA Certification: Financial Interests and Arrangements of Clinical Investigator, Form 3454
• FDA Disclosure: Financial Interests and Arrangements of Clinical Investigators, Form 3455
• DHHS Handling Misconduct: Introduction

Information on NCI Adverse Events Reporting

• Common Terminology Criteria for Adverse Events (CTCAE) v4.0

NCI Links

• Clinical Trials Management Resource Website
• NCI Booklet: "Taking Part in Cancer Treatment Research Studies"
• NCI Data and Safety Monitoring Guidelines (PDF, 108 KB)
• NCI R&D Resources
• Certificates of Confidentiality

NIH Links

• Required Education in the Protection of Human Research Participants
• NIH Policy on Inclusion of Women and Children in Clinical Trials

Other Government Links

• The Belmont Report
• FDA Investigational New Drug (IND) Requirements
• Good Clinical Practice (GCP) in FDA-Regulated Clinical Trials
• IRB Registration and Assurance Filing
• Model Informed Consent for Storage & Use of Human Tissues
  • National Bioethics Advisory Commission publications