Transcript DAERS Production Training Presentation

Division
of AIDS
Data Interchange
Agenda
Division
of AIDS
Data Interchange
Division
of AIDS
Data Interchange
Division
of AIDS
Data Interchange
DAERS Selected
Features
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.
Updated 8/27/2010
4
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.
Updated 8/27/2010
5
Division
of AIDS
Data Interchange
Division
of AIDS
Data
Interchange
Frequently
Asked
Questions
“I have forgotten my username /password or the
system has locked me out because of too many
failed login attempts, how can I log into DAERS?”
Updated 8/27/2010
7
Division
of AIDS
Data
Interchange
Frequently
Asked
Questions
“My internet connection is so slow, it is not allowing
me to complete the DAERS report.”
Ways to troubleshoot:
• Determine if other internet websites are moving slowly as well by
opening another website and comparing its speed to DAERS
• Close all other running programs and windows
• Enter the expedited report when internet traffic is lower, i.e. evening
hours
If your internet connection is too slow, or there is no
connection and cannot be fixed:
Complete the paper form (available on the RSC website) and email or fax to
the RSC Safety Office ([email protected] / Fax #:
301-897-1710)
Please include an explanation in the email or fax cover page to explain your
difficulty.
Updated 8/27/2010
8
Division
of AIDS
Data
Interchange
Frequently
Asked
Questions
“How do we request training and access to DAERS
for a NEW Reporter/Submitter?
Site Enrollment Module
• CRS Leader or CRS Coordinator must submit a “New User”
request
• DAERS Training team will provide a link to the DAERS central
training registration website
• CRS staff selects a training session
• E-mail confirmation message with Web and teleconference
details will be emailed at least 1 week prior to the training
date
• DAIDS-ES Support will notify the CRS Leader and CRS
Coordinator that request has been completed
• DAIDS-ES Support will send log in details directly to each new
site user
Updated 8/27/2010
9
Division
of AIDS
Data
Interchange
Frequently
Asked
Questions
“How do I receive refresher training or training for
informational purposes only on DAERS?”
You may take DAERS training as
many times as you like!
Send an email request to DAIDS-ES Support at
[email protected]
The link to the DAERS central training registration website
will be sent
Register for the session of your choice
Updated 8/27/2010
10
Division
of AIDS
Data
Interchange
Frequently
Asked
Questions
“My physician/DAERS submitter is not available or
has not been trained to submit the report in the
DAERS system, but it is due now.”
The Reporter should enter the expedited report
into the system, complete it, and then:
Send an email to the RSC Safety Office at
[email protected] requesting that
the RSC submit the report on your behalf
Within 3 reporting days the Submitter must use the Update
feature to submit their electronic signature
There is NO need to submit a paper copy of the expedited
report
Updated 8/27/2010
11
Division
of AIDS
Data
Interchange
Frequently
Asked
Questions
Division
of AIDS
Data
Interchange
Frequently
Asked
Questions
of AIDS Case
Data
Interchange
ReportingDivision
Timelines
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
Updated 8/27/2010
15
Division
of AIDS
Data
Interchange
Submission
Timelines
(cont)
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.
Updated 8/27/2010
16
Division
of AIDS
Data Interchange
Copy Feature
Division
of AIDS
Data Interchange
EAE Notification
Recipients
Division
of AIDS
Data Interchange
Site Enrollment
Module
Division
of AIDS
Data Interchange
Site Enrollment
Module
Division
of AIDS
Data Interchange
Site Enrollment
Module
of AIDS
Data Interchange
DAERS Division
Training
Information
Training on the DAERS v1.60 New
Features is currently being offered!
Send an email request to DAIDS-ES
Support at
[email protected]
The link to the DAERS central training
registration website will be sent
Register for the New Features training
session of your choice
Updated 8/27/2010
22
of AIDS
Data Interchange
DAERS Division
Information
& Forms
Instructions and necessary documents are
found on the RSC website:
http://rsc.tech-res.com/safetyandpharmacovigilance/
Examples of some necessary documents
- Frequently Asked Questions (FAQs)
- Instructions for DAERS Site
Enrollment
- DAERS Reference Guide
Updated 8/27/2010
23
Division
of AIDS
Data Interchange
DAERS Contact
Information
Questions about …
DAERS
E-mail:
[email protected]
Phone:
1-866-337-1605 (USA)
+ 1-240-499-2239
(International)
Fax:
1-866-337-1606 (USA)
+ 1-301-948-2242
(International)
DAIDS Expedited Reporting
Manual or DAIDS Reporting
Requirements
E-Mail:
DAIDSRSCSafetyOffice
@tech-res.com
Phone:
1-800-537-9979 (USA)
+1-301-897-1709
(International)
Fax:
1-800-275-7619 (USA)
+1-301-897-1710
(International)
When in doubt, copy both.
Updated 8/27/2010
24
Division
of AIDS
Data Interchange
DAERS DEMONSTRATION
& CASE STUDY
Updated 8/27/2010
25