Cancer Therapy Evaluation Program Adverse Event Reporting System (CTEP-AERS)

• NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs (PDF)
• CTEP/NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection (3/25/2020) (PDF)
• Guidance for SAE Reporting When an SAE Report is Initiated Outside the Rave/CTEP-AERS Integration on a Rave/CTEP-AERS Integrated Study (PDF)

CTEP-AERS Application

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

In the rare event when Internet connectivity is disrupted a 24-hour notification is to be made to NCI by telephone at: 301-897-7497, or 301-897-7402 for CIP studies. An electronic report MUST be submitted immediately upon re-establishment of internet connection.

CTEP-AERS Training Guide

The CTEP-AERS Training Guide details the functionality of CTEP-AERS to submit serious adverse events electronically.

CTEP-AERS Frequently Asked Questions

CTEP-AERS Training Presentations

• CTEP-AERS Training Slides
• CTEP-AERS vs AdEERS Training Slides
• CTEP-AERS Training Recording — This is a recorded training session with opening presentation, walkthrough of CTEP-AERS information on the CTEP Website and an actual demo of the CTEP-AERS system as it compares to AdEERS. This session is the same material covered in the CTEP-AERS training webinars and is best viewed in Internet Explorer.

CTEP-AERS Training / Practice (beta) Site

The CTEP-AERS Training / Practice (beta) Site is the training version of CTEP-AERS. Users may practice submitting expedited adverse event reports to familiarize themselves with CTEP-AERS. Expedited reports submitted through this site will NOT be reviewed by CTEP. Please use the production version of CTEP-AERS for all real adverse event reports.

CTEP Adverse Event Listserv (formerly known as the AdEERS Listserv)

The CTEP Adverse Event Listserv (formerly known as the AdEERS Listserv) is a communication mechanism by which CTEP informs the community of important information regarding adverse event reporting to CTEP.

To Subscribe via Email:

Send an e-mail to LISTSERV@LIST.NIH.GOV with the following text in the message body:

subscribe AdEERS your name

Note: Fill in your name with your name as you would like it shown on the Listserv. LISTSERV will get your email address from the "From" address of your e-mail message.

To Subscribe via the Web:

• Go to https://list.nih.gov/.
• Click 'Log in' and log in (if you already have a password) or click 'get a new LISTSERV password' if you have not previously registered.
• Follow the directions to create a password.
• You will receive a confirmation request email. Follow the directions to confirm your intent to create a LISTSERV password.
• After confirming you password, return to the log-in screen and log in.
• After logging in, you will see the LISTSERV archives. Click on [AC-AOA] and scroll down until you find the list "ADEERS" and click on it.
• On the far right hand side of the page you will see an option to 'Subscribe or Unsubscribe.' Click this link and follow the instructions to subscribe to the Listserv.

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.