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Frequently Asked Questions

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DAIDS Adverse Experience Reporting System (DAERS)

Entering EAEs
  1. Why is it necessary to fill out additional EAEs when participants are on multiple studies?  Is there a way that these can be completed once?
  2. I am trying to create/submit an EAE using DAERS, but I don’t see my protocol in the drop-down list. What’s wrong?
  3. I am creating a new report; when entering a PID in the required field there are no matching PIDs found.  This PID was enrolled on a protocol and should have been provided by the DMC.
  4. Why does DAERS ask for the HIV Status Date for participants who are required to be HIV+ on a study?  I put the date of the Antibody (Ab) and Western Blot (Wb) test result there; but I am not sure if that is what it wanted.
  5. I am reporting an EAE for a participant who is not on study drugs.  How do I override the study section?  DAERS will not do the completion check without this section.
  6. When the patient is using a combination of drugs (e.g CBV), do we need to add the complete dose (sum of both components) or how do we show the dose of each component separately?
  7. Why is it so difficult to enter Concomitant medications?  Some patients may take many Concomitant medications; do we have to enter them all one by one?
  8. How do we add more than one study medication in DAERS?
  9. How do we attach additional information such as Logs or Lab results?
  10. How do I enter the dates of administration for vaccines?
Updating EAEs
  1. I need to update an EAE with a corrected death date in DAERS that occurred in Jan 2007.  Upon updating the EAE with the corrected information, and doing a completion check, there were numerous incomplete fields.  The EAE was in DAERS, but had no other information.  Do we have to enter the whole event in DAERS when updating an EAE that occurred prior to DAERS?
Submitting EAEs
  1. I submitted an EAE with the wrong PID #.  How do I correct the PID #?
  2. I do not have a DAERS login.  Can this report be sent to the RSC by e-mail or fax?
  3. We have additional staff who would like to be notified when EAEs are submitted on certain protocols at our site.  Is there a way we can create an e-mail recipient list without having to enter their e-mail addresses each time an EAE is submitted?
System Problems
  1. Sometimes there is quite a bit of lag time to reach the successfully saved on screen confirmation for each section.  What should I do if the screen takes an unusually long to time to save the information for a section?
Emergency Information
  1. My physician/DAERS submitter is not available to submit the report in the DAERS system, but it is due now.
  2. My internet connection is not allowing me to complete the DAERS report.

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Training and Access

1. How do I sign up for DAERS training? How will DAERS training be facilitated?

Training is provided in a web based format that is designed to be self-paced to offer flexibility and accessibility. This training is a required part of the overall process of obtaining access to DAERS.

DAERS training can be found in the DAIDS Learning Management System (LMS). For more information, please visit: https://daidslms.plateau.com/plateau/user/login.do. Keyword search in DAIDS LMS: DAERS

If you do not have access to the DAIDS LMS, please visit the following link to request an account: https://daidslms.plateau.com/learning/user/selfRegisterInit.do

2. What other steps are required for DAERS access?

For users at existing sites your CRS Leader or CRS Coordinator must  also submit a “New User” request on your behalf to DAIDS-ES Support using the DAERS Site Enrollment Module.

  • DAERS 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.tech-res.com/safetyandpharmacovigilance/expeditedreportingdaers.aspx

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

3. We have completed DAERS training, but have not received our login details yet.  When will we know we have access to the system?

Site staff will know that they have access to DAERS when they receive an e-mail from DAIDS-ES Support containing their login details. Login details will be delayed for the site staff who have attended the training if the protocols they require access to do not have at least one study physician who has fulfilled ALL the criteria stated below;
  • Has submitted a completed and signed Electronic Signature Attestation form.
  • Has been verified by RSC against the Form FDA 1572 or IoR Agreement.
  • Has completed training.
If all of the above criteria have been met and you have not received your DAERS login details, please e-mail DAIDS-ES Support at DAIDS-ESSupport@niaid.nih.gov to follow up on the status of your DAERS user accounts.
4. Whenever I need to use DAERS, it seems that my password has expired. What can I do?

Due to federal information security guidelines, the DAERS password expires every 60 days. To be sure that you always have
access when you need it, you can create an appointment in your Outlook calendar to remind you to reset your password. As
always, you can contact DAIDS ES Support (DAIDS-ESSupport@niaid.nih.gov) to get a temporary password, but remember that the Help Desk hours are Monday to Friday, 8:30 AM-5:30 PM Eastern Time.

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Entering EAEs

5. Why is it necessary to fill out additional EAEs when participants are on multiple studies?  Is there a way that these can be completed once?

If the participant is co-enrolled on another DAIDS study:
  • 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.
6. I am trying to create/submit an EAE using DAERS, but I don’t see my protocol in the drop-down list. What’s wrong?

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 protocols.

     

  • 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. If you do not have a copy of the old SAE form, please request a copy from the DAIDS RSC).
  • 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.

7. I am creating a new report; when entering a PID in the required field there are no matching PIDs found.  This PID was enrolled on a protocol and should have been provided by the DMC.

The DMCs provide the accrual data for the PIDs to DAIDS-ES. This data is uploaded and quality checked by DAIDS-ES. This might result in a lag and thus the PID may not be displayed in DAERS.  It is also possible that the DMC has not submitted updated PID data to DAIDS-ES at the time you are entering the EAE. In both cases, you may manually enter the PID. Additionally, the PID in DAERS does not include a check digit. You may miss the PID in the list of values if you are looking for a check digit.
8. Why does DAERS ask for the HIV Status Date for participants who are required to be HIV+ on a study?  I put the date of the Antibody (Ab) and Western Blot (Wb) test result there; but I am not sure if that is what it wanted.

HIV status date is the date the last test for HIV was conducted on the participant.
  • 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.
9. I am reporting an EAE for a participant who is not on study drugs.  How do I override the study section?  DAERS will not do the completion check without this section.

If the participant is not on any study drugs or study vaccines, the EAE is not reportable in DAERS.
10. When the patient is using a combination of drugs (e.g. CBV), do we need to add the complete dose (sum of both components) or how do we show the dose of each component separately?

You may enter a “/” to separate each dosage amount for each drug component.
11. Why is it so difficult to enter Concomitant medications?  Some patients may take many Concomitant medications; do we have to enter them all one by one?

If there were any Concomitant medications that may have contributed to the primary adverse event, the details should be entered one by one in the Concomitant medications section. Any additional Concomitant medications being taken at the onset of the primary adverse event should be faxed, e-mailed, or attached to the report using the Additional Information screen.

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

12. How do we add more than one study medication in DAERS?

Use the “New” button at the bottom of the screen to add more study agents.
13. How do we attach additional information such as Logs or Laboratory results?

You may attach/upload additional information for the EAE in the Additional Information section. You must select the ‘Uploaded in DAERS’ checkbox in the applicable section if you are attaching additional information for Primary Adverse Event, Concomitant Medications, Laboratory Tests or Diagnostic Tests.
14. How do I enter the dates of administration for vaccines?

If you are reporting an initial event, create a new EAE in DAERS. Go directly to the Study Vaccine page if you have entered the information prior to this page. Fields will no longer be grayed out once you select your study vaccine when entering information for the first time in an Initial EAE.

If you are updating an event which requires adding the dates of administration, start by searching for the event, select Update, and save the Reporter Information screen to create the EAE update. Once you create the update, go to the Study Vaccine page. For an update, the bottom of the screen will list the vaccine(s) that you have previously entered, in blue. Once you click on the vaccine, you will be able to edit the vaccine information.

Entering dates of administration: First select a date on the calendar or type directly into the Dates of Administration field in the DD/MM/YYYY format. Once you have selected or typed the first date of administration, click the blue (+) icon to the right of the date. This adds the date to the system. *Important note:* Even if you are entering only one vaccination date, you still need to click the blue (+) icon in order for the date to save in the system. You will notice that action adds the dates below the Dates of administration field.

In order to enter additional dates, repeat the same steps as above. Select a date on the calendar or type it directly into the field, and then click on the blue (+) icon to add the date to the system. You will then see both dates listed below the Dates of Administration field, indicating both dates have been entered. If you enter a date incorrectly, there are blue (-) icons next to each date, which you can click on to delete the date.

Once you have entered all dates of vaccination, click the Save button at the bottom of the page and wait for the green “Successfully saved…” message to ensure that the information has been properly captured in the system. To enter another vaccine, click New and repeat above steps for entering the date(s) of administration.

For an Initial: continue to enter all other applicable information on the other screens, and go through Completion Check once you have entered all pertinent information. The Submitter can then submit the event.

For an Update: If this is the only information you are updating, go through Completion Check and have the Submitter at your site submit the update. If there is additional information to be added, complete all other updated information and then go through Completion Check and have the Submitter at your site submit the update.


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Updating EAEs

15. I need to update an EAE with a corrected death date in DAERS that occurred in Jan 2007.  Upon updating the EAE with the corrected information, and doing a completion check, there were numerous incomplete fields.  The EAE was in DAERS, but had no other information.  Do we have to enter the whole event in DAERS when updating an EAE that occurred prior to DAERS?

For EAEs that were sent to the RSC prior to the rollout of DAERS, the data was migrated into to DAERS so that updates to those reports could be created in DAERS.  For the migrated reports, only certain fields and sections were carried over in the migration; therefore you may notice some blank fields where there may have been data in the paper form. If desired, you may re-enter the missing optional fields in your update report.

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Submitting EAEs

16. I submitted an EAE with the wrong PID #.  How do I correct the PID #?

Once you have submitted the EAE, you cannot change the PID that was selected. However, if you have not yet submitted the Initial EAE (i.e., the status of the EAE report is either “Pending” or “Ready for Final Review”), you are able to correct the PID on the Patient Information screen.
  • 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 are able to correct the PID on the Patient Information screen by typing in the correct PID and clicking “Change PID.”
17. I do not have a DAERS login.  Can this report be sent to the RSC by e-mail or fax?

Yes, the RSC will accept EAEs via e-mail or fax at 1-301-897-1710 using the old paper form or the printed out DAERS EAE form. It is highly encouraged that site staff complete the necessary steps to obtain access to the DAERS system and complete EAE through DAERS.
18. We have additional staff who would like to be notified when EAEs are submitted on certain protocols at our site.  Is there a way we can create an e-mail recipient list without having to enter their e-mail addresses each time an EAE is submitted?

There are 2 ways to add recipients to receive EAE notifications automatically:
  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.

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System Problems

19. Sometimes there is quite a bit of lag time to reach the successfully saved on screen confirmation for each section.  What should I do if the screen takes an unusually long to time to save the information for a section?

Internet connection speeds vary depending on circumstances at each CRS, i.e. time of day/high internet traffic, slower connections in remote areas, broadband vs. dial up vs. satellite connection, etc. These different circumstances will impact the speed of DAERS. You can use the following options to troubleshoot in order to determine whether the lag time is a DAERS system issue or an internet connection issue.
  • 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.

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Emergency Information

20. My physician/DAERS submitter is not available to submit the report in the DAERS system, but it is due now.

The reporter should enter the EAE report into the system, perform the Completion Check to put the EAE in the Ready for Final Review status, and then:
  • 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.
21. My internet connection is not allowing me to complete the DAERS 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.

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