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Resources

  • Clinical Trial Sources
  • Clinical Trials Plan
  • Cooperative Group Guidelines
  • Community Clinical Oncology Program (CCOP)
  • Investigator Resources
  • Childhood Cancer Resources
  • Research Resources
  • Directory of Research Tools and Services
  • CTEP Electronic Resources
  • AIDS Malignancy
  • Gynecologic Cancer Intergroup (GCIG)
  • The Breast Cancer Intergroup of North America (TBCI)
  • Related Links

Funding Opportunities

  • Reading Room for RFP N02-CM-37029-23, Clinical Trials and Information Management Support
  • Grant Funding Resources and Assistance
  • Quick Trials
  • Program Announcements (PAs)
  • Requests for Applications (RFAs)
  • Notices (including availablity of supplemental support)
  • Requests for Proposals (RFPs)
  • Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR): Grants and Contracts Funding
  • Plans and Priorities for Cancer Research
  • Surgical Oncology and Gynecologic Oncology Funding and Training Opportunities
  • Translational Research Initiative (formerly Translational Research Fund)

Guidelines and Tools for Protocol Development and Review

  • Investigators' Handbook
  • Letter of Intent (LOI)
  • Concept Submission
  • List of Codes and Values
  • Protocol Templates and Applications
  • Organ Dysfunction Studies Information
  • CTEP Amendment Requests
  • NCI Standard Protocol Language for Collaborative Agreements
  • Patient Confidential Disclosure Agreement
  • Non-Protocol Access to Experimental Agents

Requisition and Management of Agents

  • Policies and Guidelines
  • Clinical Drug Request (NIH-986) Form
  • NCI Investigational Drug Accountability Form
  • NCI Transfer Investigational Agent Form
  • NCI Return Investigational Agent Form

Reporting Guidelines

  • Clinical Data Update System (CDUS)
  • CTCAE (formerly known as CTC) v2.0 and v3.0
  • Adverse Event Guidelines (AdEERS)
  • Gender & Minority Accrual Data
  • NCI Secondary AML/MDS Form

Monitoring of Clinical Trials

  • Office for Human Research Protections - IRB Registration and Assurance Filing
  • International Cooperative Project Assurance
  • Guidelines for Monitoring of Clinical Trials for Cooperative Groups and CCOP Research Bases
  • Multicenter Guidelines
  • Data and Safety Monitoring (DSM)
  • NCI Cooperative Group Monitoring Committee Policy
  • Clinical Trials Monitoring Service (CTMS)/Theradex

Industry Collaborations

  • CTEP Interaction with Industry
  • NCI Cooperative Group - Industry Relation Guidelines
  • Clinical Trials Agreement (CTA)
  • Technology Transfer: Development and Licensing
  • Intellectual Property Option Policy

Human Research Protections

  • Office for Human Research Protections
  • Institution Review Board (IRB) Guidelines
  • Central IRB Project

 

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(Under Revision)

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Clinical Trial Resources:

Cancer Clinical Trials: A New National System


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