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| |« Return to Frequently Asked Questions Subject List.
DAIDS Adverse Experience Reporting System (DAERS)Entering EAEs
- 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 Lab results?
- How do I enter the dates of administration for vaccines?
- 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?
- I submitted an EAE with the wrong PID #. How do I correct the PID #?
- I do not have a DAERS login. Can this report be sent to the RSC by e-mail or fax?
- 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?
- 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?
- My physician/DAERS submitter is not available to submit the report in the DAERS system, but it is due now.
- My internet connection is not allowing me to complete the DAERS report.
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. The training is a required part of the overall process of obtaining access to DAERS, and the certificate documenting DAERS training completion must be sent to NIAID CRMS at CRMSsupport@niaid.nih.gov.
DAERS training can be found in the Learning Management System (LMS). The LMS is part of the DAIDS Learning Portal. For more information, please visit: https://www.daidslearningportal.com/.
- If you do not have an existing user account, please visit the following link to request an account: https://www.daidslearningportal.com/user/register.
- If you have an existing user account, log into the LMS and complete a keyword search with the term “DAERS”.
|2.||What steps are required for DAERS access?|
The following steps should be taken by CRS staff to obtain access to DAERS:
- The CRS Leader or CRS Coordinator requests access for CRS staff using the Site Enrollment Module in DAERS for all protocols with EAE reportability to DAIDS. They must provide the user's name, contact information (e-mail, phone, and fax) and DAERS role (i.e., "reporter" or "submitter") for each protocol.
- Selected staff must complete the on-line DAERS training (i.e., DAERS – New User Introductory Webinar) on the DAIDS Learning Portal at https://www.daidslearningportal.com/.
- Selected staff must send a certificate documenting training completion to NIAID CRMS Support at CRMSSupport@niaid.nih.gov.
- "Submitters" must
- Mail a signed, original, hard copy study physician Attestation and Agreement for Electronic Signatures form (see http://rsc.tech-res.com/safetyandpharmacovigilance/expeditedreportingdaers.aspx) to the DAIDS RSC Safety Office, and
- Be study physicians listed on either the FDA 1572 form or DAIDS Investigator of Record Agreement (IoRA) form. Note: These documents must be submitted to the DAIDS Protocol Registration Office at the DAIDS RSC during protocol registration.
Note: To expedite access, an electronic version of the electronic signature attestation form will be accepted with the understanding that the original hard copy is being mailed. Access to DAERS will be revoked if the hard copy is not received after the request was received per the following timeline:
- Domestic sites: within 2 weeks
- Foreign sites: within 4 weeks
MAIL THE ORIGINAL SIGNED ATTESTATION FORM(S) TO:
DAIDS RSC Safety Office
6500 Rock Spring Drive, Suite 650
Bethesda, MD 20817 (USA)
|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 NIAID CRMS 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; |
If all of the above criteria have been met and you have not received your DAERS login details, please e-mail NIAID CRMS Support at CRMSsupport@niaid.nih.gov to follow up on the status of your DAERS user accounts.
- 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.
|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 NIAID CRMS Support (CRMSsupport@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.
|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-Reference-Guide-Site-Enrollment-Users-Oct2015.pdf). Permissions to report and/or submit on the protocol will be granted once this request has been processed by NIAID CRMS 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.
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 NIAID CRMS Support (CRMSsupport@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 NIAID CRMS. This data is uploaded and quality checked by NIAID CRMS. 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 NIAID CRMS 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.
Latest News & Updates
- 2016 Network meeting safety trainings available on the Safety and Pharmacovigilance Training page
August 16, 2016
- Updated versions of the Division of AIDS Risk Worksheet Guidelines, DAIDS Protocol Risk Worksheet, and the applicable SOP are now available on the Protocol Development Information page.
July 28, 2016
- Learn more about DAIDS and its collaborators! An interactive tool DAIDS Collaborators – Roles in the DAIDS Clinical Trial Lifecycle has been posted to the Tutorials and Tools page.
June 22, 2016
- Two DAIDS Informed Consent Templates are now available on the Protocol Development Information page. For more detailed information and resources, review the Broadcast Memo.
February 23, 2016
- The New DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 2.0) training presentation is available on the Safety and Pharmacovigilance Training page.
February 5, 2016
- Do you know about HANC? The Office of HIV/AIDS Network Coordination (HANC) is a valuable resource for DAIDS Clinical Trial Networks and Site Personnel. Click here to learn more.
December 14, 2015
- The Protocol Development Lifecycle and DAIDS Study Status documents have been posted to the Protocol Development Information Page
December 11, 2015
- Updated IND and non-IND Protocol Lists have been Posted to the Case Report Form (CRF) Management Page. Click here to learn more.
December 3, 2015
- Updated reference documents for DAERS access and use have been posted to the Safety and Pharmacovigilance Expedited Reporting: DAERS page
November 20, 2015