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.
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.
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:
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.
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.
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.
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.
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.
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.