1. Division of AIDS Data Interchange

2. Division of AIDS Data Interchange Agenda

3. Division of AIDS Data Interchange

4. Division of AIDS Data Interchange 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. 4 DAERS Selected Features Updated 8/27/2010

5. 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. 5Updated 8/27/2010

6. Division of AIDS Data Interchange

7. Division of AIDS Data Interchange Updated 8/27/2010 7 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?”

8. Division of AIDS Data Interchange Updated 8/27/20108 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 (DAIDSRSCSafetyOffice@tech-res.com / Fax #: 301-897-1710) Please include an explanation in the email or fax cover page to explain your difficulty.

9. Division of AIDS Data Interchange Updated 8/27/20109 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

10. Division of AIDS Data Interchange Updated 8/27/201010 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 DAIDS-ESSupport@niaid.nih.gov The link to the DAERS central training registration website will be sent Register for the session of your choice

11. Division of AIDS Data Interchange Updated 8/27/201011 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 DAIDSRSCSafetyOffice@tech-res.com 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

12. Division of AIDS Data Interchange Frequently Asked Questions

13. Division of AIDS Data Interchange Frequently Asked Questions

14. Division of AIDS Data Interchange Reporting Timelines Case

15. Division of AIDS Data Interchange Past Due Submission Reports that are not submitted within the three reporting days will require an explanation for the delay in submission 15Updated 8/27/2010

16. Division of AIDS Data 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. 16 Submission Timelines (cont) Updated 8/27/2010

17. Division of AIDS Data Interchange Copy Feature

18. Division of AIDS Data Interchange EAE Notification Recipients

19. Division of AIDS Data Interchange Site Enrollment Module

20. Division of AIDS Data Interchange Site Enrollment Module

21. Division of AIDS Data Interchange Site Enrollment Module

22. Division of AIDS Data 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 DAIDS-ESSupport@niaid.nih.gov The link to the DAERS central training registration website will be sent Register for the New Features training session of your choice Updated 8/27/201022

23. Division of AIDS Data Interchange DAERS 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 8/27/201023

24. Division of AIDS Data Interchange DAERS Contact Information 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) DAERS E-mail: DAIDS- ESSupport@niaid.nih.gov Phone: 1-866-337-1605 (USA) + 1-240-499-2239 (International) Fax: 1-866-337-1606 (USA) + 1-301-948-2242 (International) Updated 8/27/201024 Questions about … When in doubt, copy both.

25. Division of AIDS Data Interchange DAERS DEMONSTRATION & CASE STUDY Updated 8/27/201025