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: NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs (PDF)

AdEERS 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. Please note that all paper AdEERS forms have been removed from the CTEP website and will NO LONGER be accepted.

Secondary Malignancies (including AML and MDS)

A secondary malignancy is a cancer caused by treatment for a previous malignancy (e.g., treatment with radiation or chemotherapy). A secondary malignancy is not considered a metastasis of the initial neoplasm. A secondary malignancy is unrelated to the first cancer that was treated, and may occur months or even years after initial treatment.

CTEP has removed the old AML/MDS form from our website. Effective August 25, 2010, all secondary malignancies that occur following treatment with an agent under an NCI IND/IDE must be reported via AdEERS. CTCAE v4.0 has three options available to describe treatment-related events:

• Leukemia secondary to oncology chemotherapy
• Myelodysplastic syndrome
• Treatment related secondary malignancy

If you are reporting in CTCAE v3.0, the event(s) can be reported as: "Secondary malignancy-Other (specify)".

This information should be updated in your next routine amendment to CTEP.

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.

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.