Clinical Trials Resource Area - Additional Resources

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 a NCI-sponsored investigational agent.

American Cancer Society: Clinical Trials Information Resource
Includes general information as well as a search tool to locate current clinical trials.

Cancer Therapy Evaluation
From the National Cancer Institute: Contains resources related to clinical trials management and evaluation

Common Toxicity Criteria for Adverse Events (CTCAE v3.0)
The NCI Common Terminology Criteria for Adverse Event (AE) v3.0 is a descriptive terminology which can be utilized for AE reporting.

Cancer Therapy Evaluation Program (CTEP) Forms (including Protocol Status Update)
CTEP Forms, Templates and Documents including Investigator Registration (1572) Forms, Protocol Development and Assembly, and Reporting Forms are available here.

Food and Drug Administration (FDA)
This is the official FDA Web Site

Information about the cost of clinical trials

International Conference on Harmonisation/Good Clinical Practice Guidelines ICH GCP)
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

Medicare coverage of clinical trials

MedlinePlus: Clinical Trials
MedlinePlus provide access to search current research related to clinical trials and includes current resources of interest to patients, families and providers.

NCI’s Office of Biorepository and Biospecimen Research (OBBR)
The NCI Office of Biorepositories and Biospecimen Research (OBBR) was established in 2005 in recognition of the critical role that biospecimens play in cancer research. The OBBR will be responsible for developing a common biorepository infrastructure that promotes resource sharing and team science, in order to facilitate multi-institutional, high throughput genomic and proteomic studies. Best Practices for Biospecimen Resources now available.

Office for Human Research Protections (OHRP)
OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections.

PDQ NCI's Comprehensive Cancer Database
Monthly updated summaries of literature from 70 journals; locating clinical trials; directory of health professionals and organizations involved in cancer care.

Code of Federal Regulations (CFR)
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.

Social Security Death Index (SSDI)
The SSDI is generated from the U. S. Social Security Administration's Death Master File.