Division of AIDS Data Interchange DAIDS Adverse Experience Reporting System (DAERS) New User Introductory Training Teleconferencing Details: US Toll Free: International Dial In: Bridge # : Last Updated: 6/11/20101

Division of AIDS Data Interchange Agenda DAIDS-ES Overview DAERS Workflow 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 Last Updated: 6/11/20102

Division of AIDS Data Interchange

Division of AIDS Data Interchange

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 notification of expedited report submission to CRS Staff and other key stakeholders. 5 DAERS Selected Features Last Updated: 6/11/2010

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. 6Last Updated: 6/11/2010

Division of AIDS Data Interchange

Division of AIDS Data Interchange

Division of AIDS Data Interchange Submission Timelines Expedited 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 AIDS Data Interchange Submission Timelines (cont) Example: Site Awareness: March 13 th at 2:00 PM Report Submission Due: March 17 th at 11:59 PM March 10Last Updated: 6/11/2010

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 11Last Updated: 6/11/2010

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. 12 Submission Timelines (cont) Last Updated: 6/11/2010

Division of AIDS Data Interchange

Division of AIDS Data 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 DAERS Replaces the User Information Sheet (UIS) Allows status views at any time Updated 6/6/ Training, Access & Maintenance of Account Information

Division of AIDS Data Interchange

Division of AIDS Data Interchange DAERS Additional Information Instructions and necessary documents are found on the RSC website res.com/safetyandpharmacovigilance/ res.com/safetyandpharmacovigilance/ If additional training is required the site should contact DAIDS-ES Support. 16Last Updated: 6/11/2010

Division of AIDS Data Interchange DAERS Contact Information DAIDS Expedited Reporting Manual or DAIDS Reporting Requirements res.com Phone: (USA) (International) Fax: (USA) (International) DAERS Phone: (USA) (International) Fax: (USA) (International) Questions about … 17 When in doubt, copy both. Last Updated: 6/11/2010

Division of AIDS Data Interchange DAERS Training Information Training on the DAERS v1.60 New Features is currently being offered! Send an request to DAIDS-ES Support at The 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 AIDS Data Interchange Training Demonstration Assessment of an Adverse Event Expedited Report Generation and Submission Creating an Expedited Report Completing an Expedited Report Submitting an Expedited Report (Only available to Submitter) Updating an Expedited Report Search Expedited Report Features Searching Expedited Reports Viewing/Modifying an Expedited Report Deleting an Expedited Report Copying an Expedited Report Additional Features Online 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! Last Updated: 6/11/2010

Division of AIDS Data Interchange Last Updated: 6/11/ Appendix – Changes in DAERS per Manual for Expedited Reporting of Adverse Events to DAIDS (Manual v2.0) by Field

Division of AIDS Data Interchange

Division of AIDS Data Interchange