Division
of AIDS
Data Interchange
DAIDS ADVERSE EXPERIENCE
REPORTING SYSTEM
(DAERS)
PRODUCTION TRAINING
Last Updated: 4/7/2010
v1.60 - Rev.2
1
Division
of AIDS
Data Interchange
Agenda
DAIDS-ES Overview
DAERS
DAERS Training and Account Information
Workflow
Selected Features
DAERS Terminology
Submission Timelines
DAERS Changes per new EAE Manual Version 2.0
Maintenance of User Account Information
DAERS Additional Information
DAERS Contact Information
Training Demonstration
Last Updated: 4/7/2010
v1.60 - Rev.2
2
Division
of AIDS
Data
Interchange
What is the
DAIDS-ES?
The DAIDS Enterprise System (DAIDS-ES) is a suite of tools, built on
a common framework that enhances clinical research by
supporting scientific, administrative and regulatory processes.
This enterprise system contains multiple integrated modules for key
business areas.
DAERS is a Secure, Confidential Web-based system that
supports Therapeutic, Vaccines and Prevention EAE Reporting
CSM is the single source for all monitoring information that supports
standardization of findings and visit reports across networks and non-networks
DPRS supports the Electronic Submission and tracking of registration materials
Last Updated: 4/72010
v1.60 - Rev.2
3
Division
of Account
AIDS
Dataand
Interchange
DAERS Training
Information
Site Leaders or Site Coordinators must submit a request to
DAIDS-ES Support for access to DAERS for all new users
through the Site Enrollment module.
All Submitters who attend training must also submit the
following information to attain access to DAERS:
Physician Electronic Signature Attestation Form
This form and directions on how to complete and send it may
be found on RCC’s website: http://rcc.techres.com/safetyandpharmacovigilance/
Completion of training and submission of forms does not
automatically generate user account for DAERS.
RCC must verify Submitters against the FDA Form 1572/IoR
Agreements on file and that the CRS is Protocol Registered for
all the protocols listed in the request for access.
At least 1 submitter must be trained at a site before account
information is sent.
Last Updated: 4/7/2010
v1.60 - Rev.2
4
Division
of AIDS
Data Interchange
High Level
DAERS
Workflow
Stop
No
Clinical
Research
Site (CRS)
AE
Occurs at
CRS
Review EAE
submission
RCC
DAERS – EAE Reporting
Report
to
RCC?
Yes
Additional
Information
Required?
Create
EAE
Submit
EAE to RCC
Update
EAE
Sends
Query to
CRS
Yes
Archive
Report
Notify
FDA &
CRS
No
Yes
Assess
EAE Report
Additional
Information
Required?
No
No
Safety
Report
Required?
Yes
Create
Safety
Report
DAIDS
Last Updated:
9/15/2009
v1.55 - Rev.1
5
DAERS (EAE
Reporting)
Selected Features
Division
of AIDS
Data
Interchange
Secure, Confidential, Web-based system
Assess the reportability of an adverse event
Create, Submit and Update EAE reports to RCC
electronically
Instant access to EAE reports
Built-in checks and list of values
Protocols
CRSs
Participant IDs
Study Interventions
Supports EAE Reporting to the Division of AIDS
E-mail notification of EAE report submission to CRS Staff
and other key stakeholders.
Last Updated:
4/7//2010
v1.60 - Rev.2
6
Division
of AIDS
Data Interchange
DAERS Terminology
Roles
Reporter – Site study staff who have the ability to create
EAE reports.
Submitter – Study Physician(s) who have the ability to
create, sign and submit EAE 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
EAE Report Types
Initial – Original EAE report sent to RCC.
Update – Once an EAE report has been submitted to RCC,
additional information is submitted through an update.
Last Updated: 4/7/2010
v1.60 - Rev.2
7
Division
of AIDS
Data Interchange
DAERS Terminology
(cont)
EAE Report Statuses
Pending
Ready for Final
Review
An EAE report has
been started by the
Reporter or
Submitter, but it has
not been finished.
The EAE report
contains all required
elements and is
ready to be reviewed
by the Study
Physician.
Submitted to
RCC
Withdrawn
The Study Physician
has approved and
sent the EAE report
to RCC.
An EAE Report
erroneously
submitted to RCC,
which is no longer
considered an
official EAE
submission.
Reporter,
Submitter or
RCC
Status
Definition
Email
Notification
Recipient
To: Reporter for
EAE, Study
Coordinator
Last Updated: 4/7/2010
To: Reporter for
EAE, All Study
Physicians on
protocol at site,
Study Coordinator
v1.60 - Rev.2
To: RCC,
Submitter, Reporter
for EAE, All Study
Physicians on
protocol at site,
Study Coordinator,
Network’s DMC,
and Site’s ICC
(where applicable).
To: Reporter or
Submitter requesting
withdrawal.
8
of AIDS
Data Interchange
DAERSDivision
Terminology
(cont)
Unique 6 digit number
assigned when report is
created
Indicates the year the
report was submitted
Last Updated: 4/7/2010
v1.60 - Rev.2
Created
Submitted
Indicates the version
of the updated report
created
Updated
Indicates the RCCassigned EAE
number prior to the
migration
Legacy
Migrated
9
Division
of AIDS
Data
Interchange
Submission
Timelines
EAE 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 EAE submitted after the third reporting day shall be considered
late.
Last Updated: 4/7/2010
v1.60 - Rev.2
10
of AIDS
Data
Interchange
SubmissionDivision
Timelines
(cont)
Example:
Site Awareness: March 13th at 2:00 PM
Report Submission Due: March 17th at 11:59 PM
March
Sunday
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
1
2
3
4
5
6
7
8
9
10
11
12
13 Site
14
15
Awareness
(2:00pm local
time)
16
17
18
19
20
21
22
23
30
24
31
25
26
27
28
29
Last Updated: 4/7/2010
Report Due
(11:59pm
local time )
v1.60 - Rev.2
11
of AIDS
Data
Interchange
Past DueDivision
Submission
Reports that are not submitted within the three
reporting days will require an explanation for the
delay in submission
Last Updated: 4/7/2010
v1.60 - Rev.2
12
of AIDS
Data
Interchange
SubmissionDivision
Timelines
(cont)
The Alerts web part on the DAERS
home screen allows users to quickly
identify EAE reports that are either
approaching their due date or past their
due date.
Last Updated: 4/7/2010
v1.60 - Rev.2
13
Division
of AIDS
Data
Interchange
DAERS Changes
per EAE
Manual Version 2.0
All new protocols will be using the EAE
Manual Version 2.0
For existing protocols, sites will be
notified by their protocol teams if your
protocols will be required to switch to
the EAE Manual Version 2.0
DAERS will automatically reflect the
changes once a protocol using the EAE
Manual Version 2.0 is selected.
Last Updated: 4/7/2010
v1.60 - Rev.2
14
Division
of AIDS
Data
Interchange
DAERS Changes
per EAE
Manual Version 2.0
After a protocol has switched to the EAE Manual Version
2.0:
Updates to EAE reports created prior to the switch will continue using
EAE Manual Version 1.0
Initial EAEs will use EAE Manual Version 2.0 regardless of the Protocol
Version it is reported against
Switch
Submitted Initial EAE
Update EAE
EAE Manual Version 1.0
EAE Manual Version 1.0
Created Initial EAE
Submit Initial EAE
EAE Manual Version 1.0
EAE Manual Version 1.0
Create Initial EAE
EAE Manual Version 2.0
Last Updated: 4/7/2010
v1.60 - Rev.2
15
ofAccount
AIDS
Data
Interchange
MaintenanceDivision
of User
Information
Adding Users to DAERS
The Site Leader or Coordinator must request access for
site staff using the Site Enrollment Module in DAERS.
• Must provide the following information for each added site staff:
– User’s Name and contact information (email, phone, fax)
– DAERS Role by Protocol
All new users must complete training.
Reporters
• Will only have access to report EAEs on protocols that have at
least one Physician who also has access to submit EAEs on those
protocols.
Submitters
• Must mail the Electronic Signature attestation from to the RCC.
• Must be listed on the FDA Form 1572 or IoR Agreement.
Last Updated: 4/7/2010
v1.60 - Rev.2
16
Division
of AIDS
Data
Interchange
Maintenance
of User
Account Information
Site Leaders and Site Coordinators are responsible for maintaining their
DAERS User’s Information through the Site Enrollment Module. This includes
the following scenarios:
Adding new users to DAERS
• When additional people join the organization, sites must follow the process to add users to DAERS.
Access to newly registered Protocols
• When a site registers to a new EAE reporting DAIDS protocol, the Site Leader or Site Coordinator
must request access for the users who have been identified for the role of Submitter or Reporter for
that particular protocol, and submit the associated documentation to DAIDS-ES Support. (Physician
Electronic Signature Attestation Form - If the submitter is not a current user of the DAERS system)
Adding access rights
• When a site user requires Reporter access to additional protocols, the Site Leader or Site Coordinator
is responsible for modifying this information.
• When a site user requires Submitter access to additional protocols, Site Leader or Site Coordinator is
responsible for modifying this information based off the FDA Form 1572/ IoR Agreement.
Removal of Access
• When a user leaves the site’s organization or is no longer on a protocol, Site Leader or Site
Coordinator is responsible for modifying this information.
Last Updated:
3/26/2010
v1.60 - Rev.1
17
DAERS Additional
Information
Division
of
AIDS
Data Interchange
Instructions and necessary documents
are found on the RCC website
http://rcc.techres.com/safetyandpharmacovigilance/
If additional training is required the
site should contact DAIDS-ES Support.
DAIDS-ESSupport@niaid.nih.gov
Last Updated: 4/7/2010
v1.60 - Rev.2
18
Division
of AIDS
Data Information
Interchange
DAERS Contact
Questions about …
DAIDS EAE Manual or DAIDS
Reporting Requirements
DAERS
E-Mail:
E-mail:
Phone:
Phone:
Fax:
Fax:
RCCSafetyOffice@tech-res.com
1-800-537-9979 (USA)
+1-301-897-1709 (International)
1-800-275-7619 (USA)
+1-301-897-1710 (International)
DAIDS-ESSupport@niaid.nih.gov
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: 4/7/2010
v1.60 - Rev.2
19
of AIDS
Data Interchange
Training Division
Demonstration
Assessment of an Adverse Event
EAE Report Generation and Submission
Creating an EAE Report
Completing an EAE Report
Submitting an EAE Report (Only available to Submitter)
Updating an EAE Report
Updating an EAE Report
Search EAE Report Features
Searching EAE Reports
Viewing/Modifying an EAE Report
Deleting an EAE Report
Copying an EAE ReportNew!
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: 4/7/2010
v1.60 - Rev.2
20
NIAID, Division of AIDS
Appendix –
Changes in DAERS per EAE Manual Version
2.0 by Field
Division
of AIDS
Data
Interchange
DAERS Changes
per New
EAE Manual Version 2.0
Field and EAE
Report Section
EAE Manual Version 1.0
New EAE Manual Version 2.0
AE Reporting
Method
(Assessment
Tool)
• EAE
• SAE (Serious Adverse Event)
• SUSAR (Suspected, Unexpected Serious
Adverse Reactions)
Level of
Reporting
(Assessment
Tool)
• Standard, Targeted, Intensive
• No Longer Displayed
Relationship to
Study
Product/Protoc
ol
(Assessment
Tool, Study
Agents/Vaccine
s)
•
•
•
•
•
•
Definitely Related
Probably Related
Possibly Related
Probably Not Related
Not Related
Pending (temporary assignment for
death)
• Related
• Not Related
Expectedness
(Assessment
Tool)
• Required for protocols with a Targeted
Level of Reporting
• Expected
• Unexpected
Last Updated: 4/7/2010
v1.60 - Rev.2
22
Division
of AIDS
Data
Interchange
DAERS Changes
per New
EAE Manual Version 2.0
Field and EAE
Report Section
EAE Manual Version 1.0
New EAE Manual Version 2.0
Country of AE
Origin
(Primary
Adverse Event)
• N/A
• Drop down list that displays all
Countries.
• User selects country where the event
occurred.
Seriousness
Criteria
(Assessment
Tool, Primary
Adverse
Event)
• Death
• Life-threatening
• Hospitalization or prolongation of
existing hospitalization
• Persistent or significant
disability/incapacity
• Congenital anomaly/birth defect
• None of the above, but is a protocolspecific reporting requirement, including
Grade 3 events as required by the
Intensive level
• None of the above, but is of sufficient
concern to report to DAIDS
• Results in Death
• Is life-threatening
• Requires inpatient hospitalization or
prolongation of existing hospitalization
• Results in persistent or significant
disability/incapacity
• Is a congenital anomaly/birth defect
• Other important medical event that
may jeopardize the subject or that
may require intervention to prevent
outcomes listed above
• None of the above, this is not an SAE,
but is a protocol-specific reporting
requirement
• None of the above, this is not an SAE,
but is of sufficient concern to report to
DAIDS
Last Updated: 4/7/2010
v1.60 - Rev.2
23