Data and Safety Monitoring

List a Trial in NCI's PDQ® Registry

Becoming a Co-Investigator

Starting a New Clinical Trial

Data Collection and Reporting

Participants in Clinical Trials

NIH Clinical Research Network Inventory

Insurance Coverage

Online Training and Education

Bibliographic Databases

General Information

Clinical Trials Reporting Program
(Posted: 04/24/2009) - Information about NCI's new 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.

Coordinating Center for Clinical Trials
Seeks to enhance the best of all the components of the NCI-supported clinical trials system to develop a cooperative enterprise built on a strong scientific infrastructure and a broadly engaged coalition of critical stakeholders.

Restructuring the NCI Clinical Trials Enterprise
This site provides information about the effort to restructure NCI's Clinical Trials Enterprise.

Common Terminology for Adverse Events (CTCAE) version 4.0
An updated version of the NCI Common Terminology Criteria for Adverse Events is now available. CTCAE v4.0 is a descriptive terminology that can be used for Adverse Event (AE) reporting. A 5-point grading (severity) scale is provided for each AE term.

List of NCI-Designated Cancer Centers
The Cancer Centers Program of the NCI supports major academic and research institutions throughout the United States to sustain broad-based, coordinated, interdisciplinary programs in cancer research.

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.

NCI Community Cancer Centers Program
NCCCP is a three-year pilot program to test the concept of a national network of community cancer centers to expand cancer research and deliver the latest, most advanced cancer care to a greater number of Americans in the communities in which they live.

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

Division of Cancer Prevention Clinical Trials Management
Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

Recommendations for the Safe Handling of Cytotoxic Drugs
A brochure (PDF file) from the National Institutes of Health's Office of Research Services.

Pediatric Brain Tumor Consortium
(Posted: 04/07/1999, Reviewed: 07/22/2009) - The Pediatric Brain Tumor Consortium is a network of medical centers that 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
(Posted: 04/27/2000, Reviewed: 01/26/2005) - 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, Reviewed: 01/26/2005) - 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® Registry

List Cancer Clinical Trials in NCI's PDQ® Cancer Clinical Trials Registry
Information about the benefits of listing clinical trials in the PDQ registry, plus the steps involved to submit a trial.

PDQ® Clinical Trial Submission Portal
An online portal that enables easy submission of clinical trials for inclusion in NCI's PDQ Cancer Clinical Trials Registry.

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 providers who are interested in becoming clinical trials investigators and incorporating clinical trials into their practice. If you are not already familiar with clinical trials, you may first wish to take the Cancer Clinical Trials Basics course.

Back to Top Starting a New Clinical Trial

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

Rapid Access to Preventive Intervention Development (RAPID) Program
This program makes the contract resources from NCI's Division of Cancer Prevention available to academic and academically affiliated investigators for preclinical and early clinical drug development.

Quick-Trials for Novel Cancer Therapies
This Funding Opportunity Announcement is intended to promote translational research in new agent/modality development with timely exploitation of new cancer-relevant therapeutic and/or preventive strategies that involve defined molecular targets.

State of the Science
This site features audiovisual presentations and transcripts from State of the Science meetings, along with links to related information.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare providers who are interested in becoming clinical trials investigators and incorporating clinical trials into their practice. If you are not already familiar with clinical trials, you may first wish to take the Cancer Clinical Trials Basics course.

Back to Top Data Collection and Reporting

Clinical Trials Reporting Program
(Posted: 04/24/2009) - Information about NCI's new 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.

Cancer Data Standards Registry and Repository
The caDSR is a database and a set of application programming interfaces and tools used to create, edit, control, deploy, and find common data elements.

Clinical Data Update System (CDUS)
Primary data reporting mechanism for all NCI-sponsored clinical trials.

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.

Common Terminology Criteria for Adverse Events and Common Toxicity Criteria
Resources for standard terminology used to name and to describe the severity (grade) of adverse events that occur in the treatment of cancer.

Back to Top Participants in Clinical Trials

Protecting Participants in Clinical Trials
(Posted: 08/30/2001, Reviewed: 05/01/2006) - A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.

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
(Posted: 05/04/2000, Reviewed: 01/26/2005) - Background information and application procedures for researchers.

Clinical Trials
(Reviewed: 05/19/2006) - This fact sheet covers types of clinical trials, who sponsors them, how they are conducted, how participants are protected, and who pays for the patient care costs associated with a clinical trial. Includes some questions to ask a health care provider before entering a clinical trial.

Back to Top NIH Clinical Research Network Inventory

Inventory and Evaluation of Clinical Research Networks
An NIH-established resource designed to promote collaboration among clinical researchers and networks by identifying research topic areas and networks currently involved in clinical studies. Profiles of existing clinical research networks are available via a database that is easy to browse or search using key words.

Back to Top Insurance Coverage

States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
(Posted: 12/19/2002, Updated: 06/01/2009) - 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
(Posted: 05/08/2009) - Information about insurance coverage of the patient care costs associated with clinical trials.

Medicare Coverage of Clinical Trials
(Posted: 08/22/2001, Updated: 01/10/2006) - A collection of material about Medicare's policy of covering routine patient care costs associated with clinical trials.

Cost of Clinical Trials
(Posted: 02/09/1999, Reviewed: 11/25/2008) - 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
(Posted: 10/15/1999, Updated: 05/08/2009) - 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

Protecting Human Research Participants
This free tutorial is for physicians, nurses, and other members of clinical research teams. If you are an extramural researcher obtaining Federal funds, check with your institution to determine if this is the training they use to fulfill the NIH requirement for education on the protection of human research participants. This course is offered by the NIH Office of Extramural Research.

Cancer Clinical Trials Basics
A Web-based course for healthcare providers and others who have a limited clinical research background and are somewhat unfamiliar with the clinical trials process.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare providers who are interested in becoming clinical trials investigators and incorporating clinical trials into their practice. If you are not already familiar with clinical trials, you may first wish to take the Cancer Clinical Trials Basics course.

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

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