division of aids data interchange. division of aids data interchange agenda

Division of AIDSData Interchange

Division of AIDSData InterchangeAgenda


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.

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DAERS Selected Features

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Division of AIDSData InterchangeDAERS 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.

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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?”


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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.


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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


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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] link to the DAERS central training registration website will be sent Register for the session of your choice


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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 behalfWithin 3 reporting days the Submitter must use the Update feature to submit their electronic signatureThere is NO need to submit a paper copy of the expedited report

Division of AIDSData InterchangeFrequently Asked Questions

Division of AIDSData InterchangeReporting Timelines Case

Division of AIDSData InterchangePast Due SubmissionReports that are not submitted within the three reporting days will require an explanation for the delay in submission

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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)

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Division of AIDSData InterchangeCopy Feature

Division of AIDSData InterchangeEAE Notification Recipients

Division of AIDSData InterchangeSite Enrollment Module

Division of AIDSData InterchangeDAERS 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

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Division of AIDSData InterchangeDAERS Information & FormsInstructions 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

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Division of AIDSData InterchangeDAERS 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)

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Questions about …

When in doubt, copy both.


DAERS DEMONSTRATION & CASE STUDY

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division of aids data interchange. division of aids data interchange agenda

Documents