Division of AIDS Data Interchange DAIDS Adverse Experience Reporting System (DAERS) New User...

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


AgendaDAIDS-ES Overview

DAERSWorkflow

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





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 Terminology

RolesReporter – 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 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.


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


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



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.

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Submission Timelines (cont)




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

Training, Access & Maintenance of Account Information


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

http://rsc.tech-res.com/safetyandpharmacovigilance/

http://rsc.tech-res.com/safetyandpharmacovigilance/

mailto:[email protected]

Division of AIDSData Interchange DAERS Contact Information

DAIDS Expedited Reporting Manual or DAIDS Reporting

Requirements

E-Mail: [email protected]

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.


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


Division of AIDSData Interchange Training DemonstrationAssessment of an Adverse Event

Expedited Report Generation and SubmissionCreating an Expedited Report

Completing an Expedited Report

Submitting an Expedited Report (Only available to Submitter)

Updating an Expedited ReportUpdating an Expedited Report

Search Expedited Report FeaturesSearching Expedited Reports

Viewing/Modifying an Expedited Report

Deleting an Expedited Report

Copying an Expedited Report

Additional FeaturesOnline Help

DAIDS-ES Support

Site Enrollment Module (Site Leaders and Site Coordinators only)Submit New Request

View Existing Requests

Adding EAE Notification Recipients (Site Leaders and Site Coordinators only) 19

New!

New!

New!




Appendix –

Changes in DAERS per Manual forExpedited Reporting of AdverseEvents to DAIDS (Manual v2.0) byField



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