RSCLogo
searchBox
Home

DAIDS Adverse Experience Reporting System (DAERS)

The DAIDS Adverse Experience Reporting System (DAERS) is an internet-based system used by DAIDS Clinical Research Sites (CRSs) to report Expedited Adverse Events (EAEs) to DAIDS. DAERS creates a centralized location for accessing EAE information for reporting purposes.


All CRSs must have access to DAERS after site activation and  before a study begins to report EAEs to DAIDS. Each CRS must have at least two staff members who have a combination of DAERS Reporter and Submitter rights.


Described below are the two user roles in DAERS that CRSs must have in order to create and submit EAEs.


 

REPORTER

SUBMITTER

PERSONNEL Any CRS staff authorized by the Investigator of Record (IoR) Any study physician listed on either the Form FDA 1572 or IoR Agreement
PERMISSIONS Initiate EAE reports in DAERS Initiate EAE reports in DAERS; Electronically sign and submit EAE reports in DAERS

Contact Information:


For questions about EAEs:

Email Email: DAIDSRSCSafetyOffice@tech-res.com
Phone Phone: 1 (800) 537-9979 (USA toll-free)
1 (301) 897-1709 (Outside USA)
Fax Fax: 1 (800) ​275-​7619 (USA toll-free)
1 (301) 897-1710 (Outside USA)
Hours Hours: Monday – Friday (except holidays)
8:00 AM to 5:00 PM Eastern Time


For questions about DAERS access or technical issues:

Email Email: CRMSSupport@niaid.nih.gov
Phone Phone: 1 (240) 778-2517
Hours Hours: Monday – Friday 
8:30 AM to 5:30 PM Eastern Time


Mail hard copy attestation form(s) to:

DAIDS RSC Safety Office
6500 Rock Spring Drive, Suite 650
Bethesda, MD 20817

 

Accessing DAERS

The following steps should be taken by CRS leadership and selected staff to obtain access to DAERS. For detailed information on obtaining DAERS access, review the following:
  • Requesting access: The CRS Leader or CRS Coordinator requests access for select CRS staff through the DAERS Site Enrollment Module. For detailed information on the DAERS Site Enrollment Module, review the following:
    PDF DAERS Reference Guide for Site Enrollment Users
    Version 1.6 - September 2015

  • DAERS training: Selected CRS staff complete the web-based DAERS training on the DAIDS Learning Portal and send their certificate documenting DAERS training completion to Email NIAID CRMS Support.
  • WebLink DAIDS Learning Portal

  • Submitters only: Submitters also must mail a signed, original, hard copy Study Physician Attestation and Agreement for Electronic Signatures form to the DAIDS RSC Safety Office.
    PDF Study Physician Attestation and Agreement for Electronic Signatures
  • Using DAERS

    Footer

    HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
    Copyright © DAIDS RSC. All rights reserved.
    This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).

    HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
    Copyright © DAIDS RSC. All rights reserved.
    This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).