Data and Safety Monitoring

List a Trial in NCI's PDQ® Database

Becoming a Co-Investigator

Starting a New Clinical Trial

Data Collection and Reporting

Participants in Clinical Trials

Insurance Coverage

Online Training and Education

Bibliographic Databases

General Information

Cancer Clinical Trials - Building a New National System
(Updated: 11/17/2003) - A fundamental change is under way in how the National Cancer Institute (NCI) develops, reviews, conducts, and supports clinical trials. The revitalized system is more flexible and more inclusive, inviting input from basic and clinical researchers, community and research oncologists, patients and families, and all groups with a commitment to improving cancer care.

Guide to NCI Cooperative Group Web Sites
(Updated: 01/15/2003) - An annotated guide to the Web sites of the NCI Cooperative Groups, which conduct clinical trials around the country and in Canada and Europe.

Community Clinical Oncology Program (CCOP)
CCOP enables patients and physicians to participate in clinical trials at 61 major research centers in 34 states across the country, the District of Columbia, and Puerto Rico.

Searching for Clinical Trials Through NCI Cancer Centers' Web Sites
(Updated: 12/10/2002) - The many Web sites maintained by NCI-designated Cancer Centers are excellent supplementary resources for locating clinical trials.

Cancer Therapy Evaluation Program
CTEP is the program within the Division of Cancer Treatment and Diagnosis that plans, assesses, and coordinates all aspects of clinical trials.

Recommendations for the Safe Handling of Cytotoxic Drugs

Pediatric Brain Tumor Consortium
(Posted: 04/07/1999, Updated: 02/10/2004) - The National Cancer Institute (NCI) announced on April 5, 1999, that it had awarded funds for a Pediatric Brain Tumor Consortium, a network of medical centers that will evaluate promising treatments for children with brain malignancies.

Clinical Trials Education Series
The Clinical Trials Education Series is designed for cancer patients, health professionals, and the general public. It consists of 13 different educational materials (books, booklets, slides, videos) that can be ordered separately or viewed online.

Back to Top Data and Safety Monitoring

Data and Safety Monitoring Guidelines
(Updated: 05/09/2002) - A guide to the formulation of DSM plans for all phases of cancer clinical trials, in accordance with NIH requirements.

Data and Safety Monitoring Example Plans
(Posted: 07/08/2002) - Examples of NCI-approved Institutional Data and Safety Monitoring Plans, submitted by NCI-designated Cancer Centers.

Back to Top List a Trial in NCI's PDQ® Database

A Quick Reference Guide for Submitting Clinical Trials to PDQ®
How to include your trial in NCI's clinical trials database.

Questions and Answers About Submitting Clinical Trials to PDQ®
FAQs regarding clinical trial submission.

Online PDQ Protocol Submission Instructions
Instructions for submitting your protocol electronically.

PDQ® - Protocol Submission Form
This is the form to submit clinical trials protocols.

PDQ® Protocol Submission Checklist
Items to be included with your protocol submission.

PDQ® - NCI's Comprehensive Cancer Database
Full description of the NCI PDQ database.

Back to Top Becoming a Co-Investigator

Cancer Trials Support Unit (CTSU)
CTSU is a pilot project sponsored by NCI for the support of a national network of physicians to participate in NCI-sponsored phase III cancer treatment trials.

Special Populations Networks
A network of 18 institutions that create and implement cancer control, prevention, research, and training programs in minority and underserved communities.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare professionals who are new to the clinical trials research process. The course contains practical information for professionals interested in referring patients to clinical trials, or conducting clinical trials, for the first time.

Back to Top Starting a New Clinical Trial

Developmental Therapeutics Program
As the drug discovery and development arm of the National Cancer Institute, the Developmental Therapeutics Program plans, conducts, and facilitates development of therapeutic agents for cancer and AIDS.

Rapid Access to Preventive Intervention Development (RAPID) Program
The ongoing Rapid Access to Preventive Intervention Development (RAPID) Program will make available to academic investigators the preclinical and early clinical drug development contract resources of NCI's Division of Cancer Prevention.

Quick-Trials for Novel Cancer Therapies

State of the Science Web Site
The National Cancer Institute holds State of the Science meetings to identify new clinical research opportunities in major cancers and stimulate the development of new clinical interventions.

Rapid Access to Intervention Development (RAID)
The Rapid Access to Intervention Development (RAID) program facilitates translation to the clinic of novel, scientifically meritorious therapeutic interventions originating in the academic community.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare professionals who are new to the clinical trials research process. The course contains practical information for professionals interested in referring patients to clinical trials, or conducting clinical trials, for the first time.

Back to Top Data Collection and Reporting

Cancer Data Standards Repository for Common Data Elements
A repository of terms that medical providers may use to collect patient information for clinical trials or for cancer care. NCI hopes to facilitate uniform standards for cancer clinical trials and patient care by assembling and maintaining this information on-line for all interested caregivers.

NCI-CTEP: Clinical Data Update System

NCI-CTEP: Adverse Event Expedited Reporting System
NCI's Web-based system NCI's Web-based system for all NCI collaborators providing electronic acquisition, exchange, submission, and analysis of expedited reports for serious and/or unexpected adverse events.

NCI-CTEP: Common Terminology Criteria for Adverse Events
Standard terminology used to name and to describe the severity (grade) of adverse events that occur in the treatment of cancer.

Division of Cancer Prevention Investigator Tools
A link to the DCP's protocol information office page.

Back to Top Participants in Clinical Trials

A Guide to Understanding Informed Consent
(Updated: 08/30/2001) - A guide to the process of informed consent, in which people considering participation in a trial learn about potential risks and benefits of the trial as well as their rights and responsibilities. Includes sample forms and templates.

Human Participant Protections Education for Research Teams
A free, Web-based course developed at the National Institutes of Health for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.

Clinical Research Training for Members of the Research Team at the NIH Clinical Center
This program responds to the federal mandate requiring human subjects protection education for research teams at the NIH Clinical Center.

Certificates of Confidentiality
(Updated: 03/20/2002) - Background information and application procedures for researchers.

Clinical Trials: Questions and Answers
An NCI fact sheet that explains clinical trials.

Back to Top Insurance Coverage

States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
(Posted: 12/19/2002, Updated: 06/14/2004) - A searchable list and map of U.S. states that require health plans to pay for the patient care costs associated with clinical trials. Key provisions are summarized.

Clinical Trials and Insurance Coverage - A Resource Guide
(Updated: 01/30/2002) - A guide to information about insurance coverage of the patient care costs associated with clinical trials.

Private Insurers' Coverage of Clinical Trials
(Posted: 08/22/2001) - A collection of material about private insurers that have agreed to provide beneficiaries with access to NCI-sponsored cancer clinical trials.

Medicare Coverage of Clinical Trials
(Posted: 08/22/2001) - A collection of material about Medicare's policy of covering routine patient care costs associated with clinical trials.

Cost of Clinical Trials
(Updated: 06/23/2003) - A collection of material about studies showing that patient care costs for clinical trials are not appreciably higher than costs for patients not enrolled in trials.

Veterans Affairs and Department of Defense Beneficiaries
(Updated: 07/21/2003) - A collection of material about an agreement allowing U.S. veterans and Department of Defense TRICARE beneficiaries to participate in NCI-sponsored cancer clinical trials as part of their health benefits.

Back to Top Online Training and Education

Human Participant Protections Education for Research Teams
A free, Web-based course developed at the National Institutes of Health for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare professionals who are new to the clinical trials research process. The course contains practical information for professionals interested in referring patients to clinical trials, or conducting clinical trials, for the first time.

Clinical Research Training for Members of the Research Team at the NIH Clinical Center
This program responds to the federal mandate requiring human subjects protection education for research teams at the NIH Clinical Center.

Back to Top Bibliographic Databases

Cancer Literature
Select from NCI's cancer education publications or search the National Library of Medicine's bibliographic database (PubMed).

PubMed
The National Library of Medicine's bibliographic database.

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