DAIDS Adverse Experience Reporting System (DAERS) Training and Access Frequently Asked Questions

How do I sign up for DAERS training? How will DAERS training be facilitated?

Training is provided in a web-based format that is designed to be self-paced to offer flexibility and accessibility. The training is a required part of the overall process of obtaining access to DAERS, and the certificate documenting training completion will be automatically sent to NIAID CRMS at CRMSsupport@niaid.nih.gov

The DAIDS Expedited Adverse Event Reporting eLearning Course training can be found in the DAIDS Learning Portal.

  • If you do not have an existing user account, please visit the following link to request an account: DAIDS Learning Portal User Registration page.
  • If you have an existing user account, log into the DAIDS Learning Portal and complete a keyword search using any of the following terms “DAERS, Clinical, Safety, Adverse Event (AE) Reporting, Systems”.

What steps are required for DAERS access?

The following steps should be taken by CRS staff to obtain access to DAERS:

  1. Requesting access: The CRS Leader or CRS Coordinator requests access for selected CRS staff through the Site Enrollment Module.
  2. Training: CRS staff complete the web-based DAIDS Expedited Adverse Event (EAE) Reporting eLearning Course on the DAIDS Learning Portal. The course certificate will be automatically sent to NIAIDS CRMS Support.
  3. Submitters only: Submitters also must mail an accurately completed, signed, original hard copy of the 21 CFR Part 11 – Attestation and Agreement for Electronic Signatures form to the DAIDS RSC Safety Office.

Additional details can be found in the DAERS Access User Guide for EAE Reporter and Submitter Rights.

We have completed the DAIDS Expedited Adverse Event (EAE) Reporting eLearning Course, but have not received our login details yet. When will we know we have access to the system?

CRS staff will know that they have access to DAERS when they receive an e-mail from NIAID CRMS Support containing their login details. Login details will be delayed if staff have not completed the steps outlined in FAQ #2. If all of the above criteria have been met and you have not received your DAERS login details, please e-mail NIAID CRMS Support at CRMSsupport@niaid.nih.gov to follow up on the status of your DAERS user account.

Whenever I need to use DAERS, it seems that my password has expired. What can I do?

Due to federal information security guidelines, the DAERS password expires every 60 days. To be sure that you always have access when you need it, you can create an appointment in your Outlook calendar to remind you to reset your password. As always, you can contact NIAID CRMS Support (CRMSsupport@niaid.nih.gov) to get a temporary password, but remember that the Help Desk hours are Monday to Friday, 8:30 AM-5:30 PM Eastern Time.

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