Division
of AIDS
Data Interchange
DAIDS Adverse Experience Reporting System
(DAERS)
New User Introductory Training
Teleconferencing Details:
US Toll Free: 1-888-887-0127
International Dial In: 001-310-539-2229
Bridge # : 225832
Last Updated: 6/11/2010
1
Division
of AIDS
Data Interchange
Agenda
DAIDS-ES Overview
DAERS
Workflow
Selected Features
DAERS Terminology
Submission Timelines
DAERS Changes per Manual for Expedited Reporting of Adverse Events
to DAIDS (Manual v2.0)
Training, Access & Maintenance of User Account Information
DAERS Additional Information
DAERS Contact Information
DAERS New Features Training Information
Training Demonstration
Last Updated: 6/11/2010
2
Division
of AIDS
Data Interchange
Division
of AIDS
Data Interchange
DAERS Selected
Division
ofFeatures
AIDS
Data Interchange
Secure, Confidential, Web-based system
Assess the reportability of an adverse event
Create, Submit and Update expedited reports to RSC
electronically
Instant access to expedited reports
Built-in checks and list of values
Protocols
CRSs
Participant IDs
Study Interventions
Supports Expedited Reporting to the Division of AIDS
E-mail notification of expedited report submission to CRS
Staff and other key stakeholders.
Last Updated: 6/11/2010
5
Division
of AIDS
Data
Interchange
DAERS
Terminology
Roles
Reporter – Site study staff who have the ability to create
expedited reports.
Submitter – Study Physician(s) who have the ability to
create, sign and submit expedited reports.
• To be a submitter, a physician:
– Must be listed on the FDA 1572 form or Investigator of Record Agreement.
– Must sign the Physician Electronic Signature Attestation Form
– Must be formally trained on the DAERS system
Expedited Report Types
Initial – Original expedited report sent to RSC.
Update – Once an expedited report has been submitted to
RSC, additional information is submitted through an update.
Last Updated: 6/11/2010
6
Division
of AIDS
Data Interchange
Division
of AIDS
Data Interchange
Division
of
AIDS
Data Interchange
Submission
Timelines
Expedited Reports are required to be signed and submitted
within three reporting days of the site awareness date.
Monday through Friday count as reporting days.
Holidays that occur on a Monday through Friday count as reporting
days.
Saturday and Sunday are considered non-reporting days.
Reporting days are counted in local time.
A reporting day starts at 12:00 am and ends at 11:59 pm.
A day is counted as a reporting day regardless of the time of the
day that awareness occurred prior to 11:59 pm.
The site awareness day shall count as the first reporting day unless
it occurs on a non-reporting day (i.e., Saturday or Sunday); in which
case, the next reporting day shall count as the first reporting day.
Any expedited report submitted after the third reporting day shall
be considered late.
Last Updated: 6/11/2010
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Division
of AIDS (cont)
Data
Interchange
Submission
Timelines
Example:
Site Awareness: March 13th at 2:00 PM
Report Submission Due: March 17th at 11:59 PM
March
Last Updated: 6/11/2010
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Division
of AIDS
Data
Interchange
Past Due
Submission
Reports that are not submitted within the three
reporting days will require an explanation for the
delay in submission
Last Updated: 6/11/2010
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Division
of AIDS (cont)
DataTimelines
Interchange
Submission
The Alerts web part on the DAERS
home screen allows users to quickly
identify expedited reports that are
either approaching their due date or
past their due date.
Last Updated: 6/11/2010
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Division
of AIDS
Data Interchange
Training, Access & Maintenance of Account
of AIDS
Data Interchange
InformationDivision
CRS Leaders or CRS Coordinators must use the
DAERS Site Enrollment Module to submit
requests for access to DAERS for all new users
and requests to modify or inactivate access for
existing users.
The DAERS Site Enrollment Module:
Allows CRS Leaders and Coordinators to expedite
the process of setting up user access to DAERS
Replaces the User Information Sheet (UIS)
Allows status views at any time
Updated 6/6/2010
14
Division
of AIDS
Data Interchange
DAERS Additional
Information
Division
of AIDS
Data Interchange
Instructions and necessary documents
are found on the RSC website
http://rsc.techres.com/safetyandpharmacovigilance/
If additional training is required the
site should contact DAIDS-ES Support.
DAIDS-ESSupport@niaid.nih.gov
Last Updated: 6/11/2010
16
of AIDS
Data Interchange
DAERS Division
Contact
Information
Questions about …
DAIDS Expedited Reporting
Manual or DAIDS Reporting
Requirements
E-Mail:
E-mail:
DAIDS-ESSupport@niaid.nih.gov
DAIDSRSCSafetyOffice@techres.com
Phone:
1-800-537-9979 (USA)
+1-301-897-1709 (International)
Fax:
Phone:
Fax:
DAERS
1-800-275-7619 (USA)
+1-301-897-1710 (International)
1-866-337-1605 (USA)
+ 1-240-499-2239 (International)
1-866-337-1606 (USA)
+ 1-301-948-2242 (International)
When in doubt, copy both.
Last Updated: 6/11/2010
17
DAERS Division
Training
of Information
AIDS
Data Interchange
Training on the DAERS v1.60 New
Features is currently being offered!
Send an email request to DAIDS-ES
Support at
DAIDS-ESSupport@niaid.nih.gov
The link to the DAERS central training
registration website will be sent
Register for the New Features training
session of your choice
Last Updated: 6/11/2010
18
Division
of AIDS
Data
Interchange
Training
Demonstration
Assessment of an Adverse Event
Expedited Report Generation and Submission
Creating an Expedited Report
Completing an Expedited Report
Submitting an Expedited Report (Only available to Submitter)
Updating an Expedited Report
Updating an Expedited Report
Search Expedited Report Features
Searching Expedited Reports
Viewing/Modifying an Expedited Report
Deleting an Expedited Report
Copying an Expedited Report New!
Additional Features
Online Help
DAIDS-ES Support
Site Enrollment Module (Site Leaders and Site Coordinators only) New!
Submit New Request
View Existing Requests
Adding EAE Notification Recipients (Site Leaders and Site Coordinators only) New!
Last Updated: 6/11/2010
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Division
of AIDS
Data Interchange
Appendix –
Changes in DAERS per Manual for
Expedited Reporting of Adverse
Events to DAIDS (Manual v2.0) by
Field
Last Updated: 6/11/2010
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Division
of AIDS
Data Interchange
Division
of AIDS
Data Interchange