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.

Important: CTEP, NCI Guidelines: Adverse Event Reporting Requirements

AdEERS Application

Web system that is used for the electronic submission and distribution of Expedited Reports

AdEERS Computer Based Training (CBT) v3.0 *

The AdEERS Computer Based Training (CBT) v3.0 reflects version 3.0 of the AdEERS application. This resource does not reflect the current version of AdEERS, but the information contained in the CBT is still applicable and can continue to be used.

The latest version of the AdEERS online help and instructions is available within the AdEERS application.

AdEERS LISTSERV FAQ (PDF)

Frequently Asked Questions regarding AdEERS and instructions on joining the AdEERS ListServ. To subscribe to the AdEERS ListServ:

1. Send an e-mail to LISTSERV@LIST.NIH.GOV with the following text in the message body:
   subscribe AdEERS your name
   Where your name is you name. LISTSERV will get your email address from the "From" address of your e-mail message.

AdEERS Templates were designed to use CTC v2.0. The Templates, Template List of Values, and Template Instructions were retired in 2003 and do not reflect current AdEERS data requirements. The Templates and related documents reside on the CTCAE/CTC Archive Web page.

AdEERS Templates

AdEERS Templates were designed to use CTC v2.0. The Templates, Template List of Values, and Template Instructions were retired in 2003 and do not reflect current AdEERS data requirements.

• Single Agent Template (Updated 2/12/2002)
  When the AdEERS web application is unavailable, this paper form is to be used to submit reports for protocols using a single agent.
• Multiple Agents Template (Updated 2/12/2002)
  When the AdEERS web application is unavailable, this paper form is to be used to submit reports for protocols using a single agent.
• AdEERS Template Instructions (Updated 2/12/2002)
  Comprehensive guide for the completion and submission of the AdEERS Templates
• AdEERS Template List of Values (Updated 2/12/2002)
  Lists of standard values that must be used to complete the Templates. When received at NCI, data submitted on Templates will be entered into the AdEERS database. Therefore, reports with free-text data entry are not acceptable and will be returned to the submitter for resubmission with the standard values.

HIPAA Presentation

This presentation serves as a tutorial to clinical sites that need assistance in obtaining Protected Health Information from an Outside Health Care Facility or Provider. The presentation also discusses how the HIPAA privacy rule pertains to clinical research.

HIPAA Documents

The HIPAA documents are a resource for clinical sites to use when they are having difficulty obtaining medical information from outside medical facilities. The instructions for using these documents can be found in the HIPAA presentation.