Do you know how to obtain access to the DAIDS Adverse Experience Reporting System (DAERS)?

Broadcast Memo
Friday, November 20, 2015

All clinical research sites (CRSs) must have access to DAERS before a study begins to report expedited adverse events (EAEs) to DAIDS. Each CRS must have at least two (2) staff who, among themselves, have a combination of DAERS “reporter” and “submitter” roles.

A “reporter” is any CRS staff whom the Investigator of Record (IoR) has authorized to initiate EAE reports using the DAERS system. A “submitter” is any study physician who will submit and electronically sign EAE reports in DAERS and who is listed on the FDA 1572 or the DAIDS IoR Agreement forms.

What are the steps that should be taken by the CRS to obtain access to DAERS?

  1. The CRS Leader or CRS Coordinator requests access for CRS staff through the Site Enrollment Module (SEM) in DAERS. The requestor must provide the name, contact information and DAERS role (i.e., “reporter”, “submitter”) or each CRS staff. Visit the DAIDS RSC Training page for more information.
  2. Selected staff complete the on-line DAERS training in the DAIDS Learning Portal. If you do not have an account, visit the following link to request an account: DAIDS Learning Portal User Registration page.
  3. Selected staff send the certificate documenting DAERS training completion to NIAIDS CRMS Support at CRMSSupport@niaid.nih.gov.
  4. Submitters also must mail a signed, original, hard copy study physician A ttestation and Agreement for Electronic Signatures form to the DAIDS RSC Safety Office. The form may be accessed by using the following link: Physician Electronic Signature Attestation form 

Who should be contacted for assistance?

For DAERS Access and Training:
NIAID CRMS Support
Phone: +1 (240) 778-2517
Email: CRMSSupport@niaid.nih.gov

For Attestation Forms and EAE Reporting:
DAIDS RSC Safety Office
Phone: +1 (800) 537-9979 (US toll free) or +1 (301) 897-1709
Email: DAIDSRSCSafetyOffice@tech-res.com
Fax: +1 (800) 275-7619 (US toll free) or +1 (301) 897-1710
Mail:
DAIDS RSC Safety Office
6500 Rock
Spring Drive, Suite 650
Bethesda, MD 20817 (USA)


This project is funded by 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 DAIDS Regulatory Support Center (RSC).