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Clinical Trials Reference Materials and Related Links

• Developing a Clinical Trial
• Agreements
• Human Subject Protection/Informed Consent
• Gender and Minority Inclusion
• Conducting a Clinical Trial
• Monitoring
• Closing Out a Clinical Trial

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Developing a Clinical Trial

NCI Request for Proposals:

• Reference Material on the planning, review, award and management of all National Cancer Institute (NCI) contracts and simplified acquisitions
• FDA IND Application Requirements

National Institutes of Health, Guide for Grants and Contracts - NIH Medical & Behavioral Research Grant Policies, Guidelines & Funding Opportunities

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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
• NIH Policy on Required Education in the Protection of Human Research Participants

Consent Forms and Instruction

• NIH OHRP Informed Consent Checklist
• NCI Informed Consent Guidelines
• NCI Recommendations on Informed Consent
• NIH Q&A on Consent for Human Tissues Research on Human Specimens
• Model Consent Form for use of Tissue for Research

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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Monitoring

• NCI Policy for Data and Safety Monitoring
• NCI Data and Safety Monitoring Guidelines
• NCI DSM Policy
• NCI DSM Addendum
• NCI DCP Monitoring Phase I and II Chemoprevention Studies (pdf, 549kb)
• FDA Adverse Events for Trials for Which NCI is not the IND Sponsor should follow FDA Regulations (MedWatch Guidelines)

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Closing Out a Clinical Trial

• Record Retention Requirements (CFR 21 312.56) for Institutional Review Board Records
• Record Retention Requirements (CFR 21 312.57) for Financial Disclosures
• Record Retention Requirements (CFR 21 312.62) for Drug Disposition and Case Histories

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