For users at existing sites, if you need DAERS training in order to gain access to the DAERS system to report and/or submit EAEs, your CRS Leader or CRS Coordinator must submit a “New User” request on your behalf to DAIDS-ES Support using the DAERS Site Enrollment Module.

• Site Enrollment Module: The DAERS Site Enrollment module enables DAIDS clinical research sites to enroll and update site staff in DAERS.  New user requests must include the site user’s name, contact information (e-mail, phone, fax) and the DAERS role by protocol.  Each Study Physician identified as a submitter must be verified by RSC against the form FDA 1572 or IoR Agreement form for their study and site. An Attestation and Agreement for Electronic Signatures form must also be sent to the RSC via fax at 301-897-1710 or e-mail at DAIDSRSCSafetyOffice@tech-res.com for all new Study Physician user requests.
   
• Attestation and Agreement for Electronic Signatures Form: A required document for any study physician who will ultimately submit and electronically sign EAE reports via the DAERS (for compliance with 21CFR Part 11).  The Study Physician (Submitter) attests that their electronic signature equates to their written signature.

Note: To expedite access, an electronic version of the document will be accepted with the understanding that the hard copy is mailed.  Access to DAERS will be revoked if the hard copy is not received within 2 weeks.

You may access the form by clicking on http://rsc.techres.com/safetyandpharmacovigilance/

MAIL THE ORIGINAL SIGNED ATTESTATION FORM(S) TO:
DAIDS RSC  Safety Office
6500 Rock Spring Drive, Suite 650
Bethesda, MD 20817

1. The DAERS Training support staff will contact the new site staff for whom access has been requested and provide a link to the DAERS central training registration website.
2. CRS staff selects a training session that they can accommodate in their schedule, completes the online registration form and submits the registration.
3. They will then receive an e-mail confirmation message stating the time and date of the training.  Web and teleconference details will be e-mailed at least 1 week prior to the training date.
4. If you would like to attend DAERS training for informational or refresher purposes only, send an e-mail request to DAIDS-ES Support at daids-essupport@niaid.nih.gov.  The link to the DAERS central training registration website will be sent so that you may register for the session of your choice.
5. For users at new sites that have registered to an EAE Reporting DAIDS Protocol, an e-mail notification will be sent automatically to the CRS Leader and CRS Coordinator with instructions to contact DAIDS-ES Support for access to the site enrollment module.

• You will need a telephone and broadband Internet connection to attend the training.  It is recommended to log into the web conference at least 20-30 minutes prior to the training, as it may require a download of the web meeting software to your computer.
   
• If your site experiences problems with telephone or internet connections during the training, please e-mail daids-essupport@niaid.nih.gov to arrange for alternate accommodations.

• Has submitted a completed and signed Electronic Signature Attestation form.
• Is verified by RSC against the Form FDA 1572 or IoR Agreement.
• Has completed training.

• Check the co-enrolled protocol(s) for EAE reporting requirements.
• Submit a separate EAE for each co-enrolled protocol in which the event is reportable.
• Use the “Copy” action button on the Search screen to copy specified details from the first EAE into the co-enrolled EAE.  This will save time with data entry.
• For questions regarding EAE reporting requirements, contact RSC at DAIDSRSCSafetyOffice@tech-res.com.

There are several reasons why a protocol may not show up in your drop-down list:

• You are not a designated Reporter or Submitter for this protocol.  (MOST COMMON!)
  • DAERS will show only protocols that list you as a DAERS Reporter or Submitter

   

• Your site is newly registered to a protocol
  • Site Leaders/Site Coordinators must provide the site staff designated for the role of Submitter or Reporter for each protocol using the Site Enrollment Module (SEM).  Please see Section 5 (page 10) of the Reference Guide for the SEM found on the RSC web site.  (http://rsc.tech-res.com/Document/safetyandpharmacovigilance/DAERS_Site_Enrollment_Reference_Guide_for_Users.pdf).  Permissions to report and/or submit on the protocol will be granted once this request has been processed by DAIDS-ES Support and RSC.
  • As of October 31, 2011, all site staff who are active reporters in DAERS have the ability to create EAE Reports on all current and future protocols at the site.  New staff must be added.  Submitters must still be designated for all protocol.

   

• The protocol uses the old DAIDS SAE manual.  (EAE reports for these protocols cannot be submitted through DAERS; they must be submitted by email/fax. http://rsc.tech-res.com/safetyandpharmacovigilance/expeditedreportingpaper.aspx)
• The protocol does not require reporting through DAIDS because the protocol is not sponsored by DAIDS.
• The protocol is a substudy and EAEs are reported through a main study.  
• The status of the protocol is “closed to follow-up” or beyond.  (EAE reports for these protocols cannot be submitted through DAERS; they must be submitted by email/fax.  http://rsc.tech-res.com/safetyandpharmacovigilance/expeditedreportingpaper.aspx)

If the protocol that you need is not showing up in your drop-down list for a reason that is not listed above, then contact DAIDS ES Support (DAIDS-ESSupport@niaid.nih.gov).  If you need to report an EAE right away, please be aware that all CRS Leaders and Coordinators have access to report EAEs on all protocols at their site.  In emergency circumstances, you can report via the paper EAE form found on the RSC web site.

• If the actual HIV Status date is not known at the time of reporting, the estimated HIV status date should be entered and the reporter should indicate the date is estimated by checking the estimated flag.
• The HIV Status fields are optional.  For studies that require participants to be HIV Infected, you may choose to skip this section.
• The HIV Status fields are helpful for studies that require participants to be HIV Uninfected, such as in Prevention and Vaccine trials, where HIV Status tests are routinely required.  This information is helpful to track over the course of the study and to give the RSC and the DAIDS Medical Officers a complete picture of the participant’s EAE.

Note: The RSC will create an update report in DAERS to enter additional information received via e-mail or fax.

• If you have submitted an EAE with the wrong PID, you must e-mail RSC (DAIDSRSCSafetyOffice@tech-res.com) to request a withdrawal of the EAE.  Once the RSC accepts your requests, the EAE will be withdrawn and will no longer be considered an official EAE.  You will need to enter a new EAE with the correct PID.
• If the EAE with the wrong PID has not been submitted, you may delete it from the Search screen using the Delete button at the end of the row.  You will be required to enter a reason for deletion.

1. A Submitter can type the recipients’ e-mail(s) in the text box on the Submit EAE screen; a pop up box will allow him to add the recipients’ name(s) and designate whether they should continue to receive EAE notifications for the protocol and site.  Once saved, the recipient’s name will be pre-populated on the Submit screen each time an EAE is submitted for the site and protocol.
    
2. The CRS Leader or CRS Coordinator can use the EAE Notifications Recipients Module to add or edit recipients for all sites and protocols to which they have access.

• Determine if other internet websites are moving slowly as well.  If so, your internet connection as a whole will have significant lag time for DAERS and all other websites.
• You may also want to enter the EAE when internet traffic is lower, i.e. evening hours.  Or if timelines are at risk, fill out the paper form and fax the EAE report to the RSC.

• Send an e-mail to the DAIDS RSC Safety Office requesting that the RSC submit the report on your behalf.  Your request must be very clear and direct to avoid potential time losses to clarify.
• Within 3 reporting days a submitter must use the update feature to submit their electronic signature.
• There is NO need to submit a paper copy of the EAE report.

• Complete the paper EAE form (available on the DAIDS RSC website) and e-mail or fax it to the DAIDS RSC Safety Office (DAIDSRSCSafetyOffice@tech-res.com / Fax #: 301-897-1710).
• Please include an explanation in the e-mail or fax cover page to explain your difficulty.