Conducting Clinical Trials
Information and tools for investigators and research teams who are already involved in clinical trials, as well as for those who are thinking about getting involved. Learn about challenges and solutions for accruing patients to trials, how to develop a protocol, the process for collaborating with NCI to develop a new agent, and registration and reporting requirements .
On this page:
Information for Investigators
- Investigator's Handbook
Manual for investigators participating in clinical trials of investigational agents sponsored by NCI's Division of Cancer Treatment and Diagnosis.
- Including Clinical Trials in Your Practice: An Overview
A Web-based course for healthcare providers who are interested in becoming clinical trials investigators and including cancer clinical trials in their practice.
- Division of Cancer Prevention Clinical Trials Management
Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.
- Industry Collaborations
Provides information regarding the process for co-developing an investigational anti-cancer agent with the NCI.
- What NIH Grantees Need to Know About ClinicalTrials.gov and FDAAA
Information to help NIH applicants and grantees (recipients of extramural grants and cooperative agreements) to understand their roles and responsibilities in relation to ClinicalTrials.gov and the Food and Drug Administration Amendments Act (FDAAA) of 2007.
Tools for Managing Clinical Trials
- Protocol Development
Guidelines and tools for protocol development, from the Cancer Therapy Evaluation Program (CTEP).
- Central Institutional Review Board Initiative
The CIRB provides an innovative approach to human subject protection through a "facilitated review" process that can streamline local IRB reviews of adult and pediatric national multicenter cancer treatment trials.
This website is designed for practicing professionals to support clinical trial accrual needs.
- Cancer Trials Support Unit (CTSU)
CTSU is a project sponsored by NCI for the support of a national network of physicians to participate in NCI-sponsored phase III cancer treatment trials.
Tools for Registration and Reporting
- Clinical Trials Reporting Program
Information about NCI's Clinical Trials Reporting Program (CTRP). The site is designed to guide clinical trial investigators and their staff through the process of registering trials with CTRP.
- Clinical Trial Information Management
A collection of tools to help facilitate the transfer of clinical trial data.
- Clinical Trials Management Systems (CTMS) Workspace
Virtual workspace within the caBIG® program where the clinical research and care communities can securely gather, exchange, explore, integrate, and reuse data and information within and among disciplines.
- Clinical Data Update System (CDUS)
Primary data reporting mechanism for all NCI-sponsored clinical trials.
- Common Terminology for Adverse Events (CTCAE)
Resources for standard terminology used to name and to describe the severity (grade) of adverse events that occur in the treatment of cancer.
- Adverse Event Expedited Reporting System (AdEERS)
NCI's Web-based system for submitting expedited reports for serious and/or unexpected events forwarded to designated recipients and the NCI for all trials using NCI-sponsored investigational agents.
Tools for Ensuring Patient Safety
- Certificates of Confidentiality
Certificates of Confidentiality background information and application procedures for researchers.
- Data and Safety Monitoring Guidelines
A guide to the formulation of DSM plans for all phases of cancer clinical trials, in accordance with NIH requirements.
- Simplification of Informed Consent Documents
Information on NCI's recommendations for simplifying informed consent documents, with guidance on how to develop them.