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.
|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|
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:
DAERS Access User Guide for EAE Reporter and Submitter Rights (Version 2.0 - August 2017)
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: DAERS Reference Guide for Site Enrollment Users (Version 1.7 – May 2018)
DAIDS Expedited Adverse Event Reporting eLearning Course
To obtain DAERS access, CRS staff are required to complete the web-based DAIDS Expedited Adverse Event Reporting eLearning Course on the DAIDS Learning Portal. The course certificate will be automatically sent to NIAID CRMS Support. This course is highly recommended for all CRS staff. DAIDS Learning Portal
Submitters also must mail a signed, original, hard copy Study Physician Attestation and Agreement for Electronic Signatures form to the DAIDS RSC Safety Office. Study Physician Attestation and Agreement for Electronic Signatures
EAEs can be submitted using DAERS after DAERS access has been obtained. Please note that NIAID CRMS is accessible only through Internet Explorer 11 and Google Chrome. NIAID CRMS DAERS
For details on DAERS usage, review the following: DAERS Reference Guide for Site Reporters and Study Physicians (Version 2.5 – May 2018)
For detailed instructions on completing DAERS EAE fields, review the following: DAERS Site User Instructional Guide for EAE Reporting (Version 1.0 - February 2015)