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.
Information for Investigators
Cancer Therapy Evaluation Program Investigator's Handbook
Manual for investigators participating in clinical trials of investigational agents sponsored by NCI's Cancer Therapy Evaluation Program in the Division of Cancer Treatment and Diagnosis.
Clinical Trial Requirements for Grants and Contracts
NIH has made several policy changes to improve the stewardship of clinical trials across the life cycle of the trial that impact the ongoing conduct, review, and management of NCI-funded clinical trials. These policies have changed the way clinical investigators develop ideas for new trials, how NIH reviews and selects clinical trials for support and oversees research progress, and how results and aggregate data are shared broadly and rapidly to ensure rigor and efficiency in the U.S. clinical trial enterprise.
Division of Cancer Prevention Clinical Trials Management
Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.
Provides information regarding the process for co-developing an investigational anticancer 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
Guidelines and tools for protocol development, from the Cancer Therapy Evaluation Program (CTEP).
Central Institutional Review Board Initiative
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.
Website designed for practicing professionals to support clinical trial accrual needs.
Cancer Trials Support Unit (CTSU)
Project sponsored by NCI for the support of a national network of physicians to participate in NCI-sponsored cancer clinical trials.
Tools for Registration and Reporting
Clinical Trials Reporting Program
A comprehensive database of all NCI-supported clinical trials. The database exists to identify gaps in clinical research and duplicative studies. CTRP helps prioritize and enhance patient accrual to trials by making physicians aware of relevant opportunities for participation in clinical trials.
Common Terminology Criteria 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.
Cancer Therapy Evaluation Program Adverse Event Reporting System (CTEP-AERS)
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 Confidentiality and Safety
Certificates of Confidentiality
Certificates of Confidentiality background information and application procedures for researchers.
Data Safety and Monitoring of Clinical Trials
Explains NCI policy for monitoring clinical trials, including the need for written policies and procedures and the responsibilities of a data safety and monitoring board, when one is required.