Clinical Trials Reference Materials and Related Links

• Agreements
• Human Subject Protection/Informed Consent
• Gender and Minority Inclusion
• Conducting a Clinical Trial
• Resources for Investigators

Agreements

• Clinical Trials Agreement
• Model Confidential Disclosure Agreements
• Cooperative Research and Development Agreement (CRADA) - Research Plan Financial and Staffing Contribution of the Parties Exception or Modifications to the CRADA

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Human Subject Protection/Informed Consent

Tutorials (or Education)

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

Consent Forms and Instruction

• NCI Informed Consent Guidelines

Guidelines

• DHHS Office for Human Research Protections: IRB Registration and Assurances/Declaration of Exemption (Common Rule)
• NCI Certificates of Confidentiality Template
• Legal and Ethical Issues Related to use of Human Specimens in Research

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Gender and Minority Inclusion

• Gender and Minority Inclusion in Statistical Design
• NIH Policy on Inclusion of Women and Minorities in a Research Population
• NIH Guidelines on Gender and Minority Inclusion in Clinical Trials
• OMB Classification of Federal Data on Race and Ethnicity

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Conducting a Clinical Trial

• FDA Good Clinical Practices - An overview of the FDA standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
• FDA Guidance for Handling Recruitment Strategies of Clinical Trials participants
• 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

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Resources for Investigators

Information on NCI Adverse Events Reporting

• Common Toxicity Criteria v2.0
  • Common Toxicity Criteria Document (PDF) [Publish Date April 30,1999]
    CTC v2.0 providing an alphabetical listing of Adverse Events with associated descriptions to grade severity.
  • Common Toxicity Criteria Manual (PDF) [Updated August 18,1999]
    Reference document based on the CTC v2.0.
  • Common Toxicity Criteria Index Terms (PDF) [Updated July 21, 1999]
    Synonyms and concepts associated with CTC v2.0 terms.
  • Common Toxicity Criteria (PDF) - Notice of Modifications [Publish Date April 30, 1999]
    Detailed listing of modifications to CTC v2.0.
  • CTC - Version 2.0 (Microsoft Access 97 Database)
    Access file to provide a spreadsheet format for integrating the CTC v2.0 into user applications
• Common Terminology Criteria for Adverse Events v3.0
• Common Terminology Criteria for Adverse Events (CTCAE) v4.0

NCI Links

• Clinical Trials Management Resource Website
• NCI Booklet: "Taking Part in Clinical Trials: Cancer Prevention Studies; What Participants Need to Know"
• NCI Informed Consent Recommendations and Template
• NCI Research Resources
• Certificates of Confidentiality

NIH Links

• Required Education in the Protection of Human Research Participants
• Essential Elements of a Data Safety and Monitoring Plan
• 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
• Investigator Form 1572
• IRB Registration and Assurance Filing
• Model Informed Consent for Storage & Use of Human Tissues
  • Research on Human Specimens
  • Legal and Ethical Issues
  • National Bioethics Advisory Commission publications

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