Division of AIDSData Interchange
DAIDS Adverse Experience Reporting System(DAERS)
New User Introductory Training
Teleconferencing Details:US Toll Free: 1-888-887-0127
International Dial In: 001-310-539-2229Bridge # : 225832
Last Updated: 6/11/2010 1
Division of AIDSData Interchange
AgendaDAIDS-ES OverviewDAERS
WorkflowSelected FeaturesDAERS TerminologySubmission TimelinesDAERS Changes per Manual for Expedited Reporting of Adverse Events to DAIDS (Manual v2.0)
Training, Access & Maintenance of User Account InformationDAERS Additional InformationDAERS Contact InformationDAERS New Features Training InformationTraining Demonstration
Last Updated: 6/11/2010 2
Division of AIDSData Interchange
Division of AIDSData Interchange
Division of AIDSData Interchange
Secure, Confidential, Web-based systemAssess the reportability of an adverse eventCreate, Submit and Update expedited reports to RSC electronicallyInstant access to expedited reportsBuilt-in checks and list of values
ProtocolsCRSsParticipant IDsStudy Interventions
Supports Expedited Reporting to the Division of AIDSE-mail notification of expedited report submission to CRS Staff and other key stakeholders.
5
DAERS Selected Features
Last Updated: 6/11/2010
Division of AIDSData Interchange DAERS TerminologyRoles
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 TypesInitial – Original expedited report sent to RSC.Update – Once an expedited report has been submitted to RSC, additional information is submitted through an update.
6Last Updated: 6/11/2010
Division of AIDSData Interchange
Division of AIDSData Interchange
Division of AIDSData Interchange Submission TimelinesExpedited 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.
9Last Updated: 6/11/2010
Division of AIDSData Interchange Submission Timelines (cont)Example:
Site Awareness: March 13th at 2:00 PMReport Submission Due: March 17th at 11:59 PM
March
10Last Updated: 6/11/2010
Division of AIDSData Interchange Past Due SubmissionReports that are not submitted within the three reporting days will require an explanation for the delay in submission
11Last Updated: 6/11/2010
Division of AIDSData Interchange
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.
12
Submission Timelines (cont)
Last Updated: 6/11/2010
Division of AIDSData Interchange
Division of AIDSData Interchange
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 DAERSReplaces the User Information Sheet (UIS)Allows status views at any time
Updated 6/6/2010 14
Training, Access & Maintenance of Account Information
Division of AIDSData Interchange
Division of AIDSData Interchange DAERS Additional Information
Instructions and necessary documents are found on the RSC website http://rsc.tech-res.com/safetyandpharmacovigilance/
If additional training is required the site should contact DAIDS-ES Support.
[email protected] 16Last Updated: 6/11/2010
Division of AIDSData Interchange DAERS Contact Information
DAIDS Expedited Reporting Manual or DAIDS Reporting
Requirements E-Mail:
Phone: 1-800-537-9979 (USA)+1-301-897-1709 (International)
Fax: 1-800-275-7619 (USA)+1-301-897-1710 (International)
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)
Questions about …
17
When in doubt, copy both.
Last Updated: 6/11/2010
Division of AIDSData Interchange DAERS 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] link to the DAERS central training registration website will be sent Register for the New Features training session of your choice
18Last Updated: 6/11/2010
Division of AIDSData Interchange Training DemonstrationAssessment of an Adverse EventExpedited Report Generation and Submission
Creating an Expedited ReportCompleting an Expedited ReportSubmitting an Expedited Report (Only available to Submitter)
Updating an Expedited ReportUpdating an Expedited Report
Search Expedited Report FeaturesSearching Expedited ReportsViewing/Modifying an Expedited ReportDeleting an Expedited ReportCopying an Expedited Report
Additional FeaturesOnline HelpDAIDS-ES Support
Site Enrollment Module (Site Leaders and Site Coordinators only)Submit New RequestView Existing Requests
Adding EAE Notification Recipients (Site Leaders and Site Coordinators only)
19
New!
New!
New!
Last Updated: 6/11/2010
Division of AIDSData Interchange
Last Updated: 6/11/2010 20
Appendix –
Changes in DAERS per Manual forExpedited Reporting of AdverseEvents to DAIDS (Manual v2.0) byField
Division of AIDSData Interchange
Division of AIDSData Interchange
Top Related