DAIDS Adverse Experience Reporting System (DAERS) Production Training

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DAIDS Adverse Experience Reporting
System(DAERS)Production Training
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Agenda

• DAIDS-ES Overview
• DAERS
• DAERS Training and Account Information
• Workflow
• Selected Features
• DAERS Terminology
• Submission Timelines
• DAERS Changes per new EAE Manual Version 2.0
• Maintenance of User Account Information
• DAERS Additional Information
• DAERS Contact Information
• Training Demonstration

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What is the DAIDS-ES?

• The DAIDS Enterprise System (DAIDS-ES) is a suite
  of tools, built on a common framework that
  enhances clinical research by supporting
  scientific, administrative and regulatory
  processes. This enterprise system contains
  multiple integrated modules for key business
  areas.

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DAERS Training and Account Information

• Site Leaders or Site Coordinators must submit a
  request to DAIDS-ES Support for access to DAERS
  for all new users through the Site Enrollment
  module.
• All Submitters who attend training must also
  submit the following information to attain access
  to DAERS
• Physician Electronic Signature Attestation Form
• This form and directions on how to complete and
  send it may be found on RCCs website
  http//rcc.tech-res.com/safetyandpharmacovigilance
  /
• Completion of training and submission of forms
  does not automatically generate user account for
  DAERS.
• RCC must verify Submitters against the FDA Form
  1572/IoR Agreements on file and that the CRS is
  Protocol Registered for all the protocols listed
  in the request for access.
• At least 1 submitter must be trained at a site
  before account information is sent.

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High Level DAERS Workflow
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DAERS (EAE Reporting) Selected Features

• Secure, Confidential, Web-based system
• Assess the reportability of an adverse event
• Create, Submit and Update EAE reports to RCC
  electronically
• Instant access to EAE reports
• Built-in checks and list of values
• Protocols
• CRSs
• Participant IDs
• Study Interventions
• Supports EAE Reporting to the Division of AIDS
• E-mail notification of EAE report submission to
  CRS Staff and other key stakeholders.

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DAERS Terminology

• Roles
• Reporter Site study staff who have the ability
  to create EAE reports.
• Submitter Study Physician(s) who have the
  ability to create, sign and submit EAE 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
• EAE Report Types
• Initial Original EAE report sent to RCC.
• Update Once an EAE report has been submitted to
  RCC, additional information is submitted through
  an update.

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DAERS Terminology (cont)
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DAERS Terminology (cont)
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Submission Timelines

• EAE 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 1200 am and ends at
  1159 pm.
• A day is counted as a reporting day regardless of
  the time of the day that awareness occurred prior
  to 1159 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 EAE submitted after the third reporting day
  shall be considered late.

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Submission Timelines (cont)

• Example
• Site Awareness March 13th at 200 PM
• Report Submission Due March 17th at 1159 PM

March
Sunday Monday Tuesday Wednesday Thursday Friday Saturday
1
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
2330 2431 25 26 27 28 29
Site Awareness (200pm local time)
Report Due (1159pm local time )
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Past Due Submission

• Reports that are not submitted within the three
  reporting days will require an explanation for
  the delay in submission

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Submission Timelines (cont)

• The Alerts web part on the DAERS home screen
  allows users to quickly identify EAE reports that
  are either approaching their due date or past
  their due date.

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DAERS Changes per EAE Manual Version 2.0

• All new protocols will be using the EAE Manual
  Version 2.0
• For existing protocols, sites will be notified by
  their protocol teams if your protocols will be
  required to switch to the EAE Manual Version 2.0
• DAERS will automatically reflect the changes once
  a protocol using the EAE Manual Version 2.0 is
  selected.

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DAERS Changes per EAE Manual Version 2.0

• After a protocol has switched to the EAE Manual
  Version 2.0
• Updates to EAE reports created prior to the
  switch will continue using EAE Manual Version 1.0
• Initial EAEs will use EAE Manual Version 2.0
  regardless of the Protocol Version it is reported
  against

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Maintenance of User Account Information

• Adding Users to DAERS
• The Site Leader or Coordinator must request
  access for site staff using the Site Enrollment
  Module in DAERS.
• Must provide the following information for each
  added site staff
• Users Name and contact information (email,
  phone, fax)
• DAERS Role by Protocol
• All new users must complete training.
• Reporters
• Will only have access to report EAEs on protocols
  that have at least one Physician who also has
  access to submit EAEs on those protocols.
• Submitters
• Must mail the Electronic Signature attestation
  from to the RCC.
• Must be listed on the FDA Form 1572 or IoR
  Agreement.

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Maintenance of User Account Information

• Site Leaders and Site Coordinators are
  responsible for maintaining their DAERS Users
  Information through the Site Enrollment Module.
  This includes the following scenarios
• Adding new users to DAERS
• When additional people join the organization,
  sites must follow the process to add users to
  DAERS.
• Access to newly registered Protocols
• When a site registers to a new EAE reporting
  DAIDS protocol, the Site Leader or Site
  Coordinator must request access for the users who
  have been identified for the role of Submitter or
  Reporter  for that particular protocol, and
  submit the associated documentation to DAIDS-ES
  Support. (Physician Electronic Signature
  Attestation Form - If the submitter is not a
  current user of the DAERS system)
• Adding access rights
• When a site user requires Reporter access to
  additional protocols, the Site Leader or Site
  Coordinator is responsible for modifying this
  information.
• When a site user requires Submitter access to
  additional protocols, Site Leader or Site
  Coordinator is responsible for modifying this
  information based off the FDA Form 1572/ IoR
  Agreement.
• Removal of Access
• When a user leaves the sites organization or is
  no longer on a protocol, Site Leader or Site
  Coordinator is responsible for modifying this
  information.

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DAERS Additional Information

• Instructions and necessary documents are found on
  the RCC website http//rcc.tech-res.com/safetyandp
  harmacovigilance/
• If additional training is required the site
  should contact DAIDS-ES Support.
• DAIDS-ESSupport_at_niaid.nih.gov

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DAERS Contact Information
Questions about

• DAIDS EAE Manual or DAIDS Reporting Requirements
• E-Mail
• RCCSafetyOffice_at_tech-res.com
• Phone
• 1-800-537-9979 (USA)
• 1-301-897-1709 (International)
• Fax
• 1-800-275-7619 (USA)
• 1-301-897-1710 (International)

• DAERS
• E-mail
• DAIDS-ESSupport_at_niaid.nih.gov
• Phone
• 1-866-337-1605 (USA)
• 1-240-499-2239 (International)
• Fax
• 1-866-337-1606 (USA)
• 1-301-948-2242 (International)

When in doubt, copy both.
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Training Demonstration

• Assessment of an Adverse Event
• EAE Report Generation and Submission
• Creating an EAE Report
• Completing an EAE Report
• Submitting an EAE Report (Only available to
  Submitter)
• Updating an EAE Report
• Updating an EAE Report
• Search EAE Report Features
• Searching EAE Reports
• Viewing/Modifying an EAE Report
• Deleting an EAE Report
• Copying an EAE 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)

New!
New!
New!
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• Appendix
• Changes in DAERS per EAE Manual Version 2.0 by
  Field

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DAERS Changes per New EAE Manual Version 2.0
Field and EAE Report Section EAE Manual Version 1.0 New EAE Manual Version 2.0
AE Reporting Method (Assessment Tool) EAE SAE (Serious Adverse Event) SUSAR (Suspected, Unexpected Serious Adverse Reactions)
Level of Reporting (Assessment Tool) Standard, Targeted, Intensive No Longer Displayed
Relationship to Study Product/Protocol (Assessment Tool, Study Agents/Vaccines) Definitely Related Probably Related Possibly Related Probably Not Related Not Related Pending (temporary assignment for death) Related Not Related
Expectedness (Assessment Tool) Required for protocols with a Targeted Level of Reporting Expected Unexpected
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DAERS Changes per New EAE Manual Version 2.0
Field and EAE Report Section EAE Manual Version 1.0 New EAE Manual Version 2.0
Country of AE Origin (Primary Adverse Event) N/A Drop down list that displays all Countries. User selects country where the event occurred.
Seriousness Criteria (Assessment Tool, Primary Adverse Event) Death Life-threatening Hospitalization or prolongation of existing hospitalization Persistent or significant disability/incapacity Congenital anomaly/birth defect None of the above, but is a protocol-specific reporting requirement, including Grade 3 events as required by the Intensive level None of the above, but is of sufficient concern to report to DAIDS Results in Death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Other important medical event that may jeopardize the subject or that may require intervention to prevent outcomes listed above None of the above, this is not an SAE, but is a protocol-specific reporting requirement None of the above, this is not an SAE, but is of sufficient concern to report to DAIDS