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Frequently Asked Questions

  • Entering EAEs FAQs


  • 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?

  • 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?

  • 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.

  • 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.

  • 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.

  • 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?

  • 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?

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

  • How do we attach additional information such as Logs or Laboratory results?

  • How do I enter the dates of administration for vaccines?

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Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).