Division of AIDS Data Interchange
DAIDS ADVERSE EXPERIENCE REPORTING SYSTEM (DAERS) PRODUCTION TRAINING
Last Updated: 4/7/2010
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Division of AIDS Data Interchange
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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Division of AIDS Data Interchange 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. DAERS is a Secure, Confidential Web-based system that supports Therapeutic, Vaccines and Prevention EAE Reporting
CSM is the single source for all monitoring information that supports standardization of findings and visit reports across networks and non-networks
DPRS supports the Electronic Submission and tracking of registration materials
Last Updated: 4/72010
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Division of Account AIDS Dataand Interchange DAERS Training 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 RCC’s website: http://rcc.techres.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. Last Updated: 4/7/2010
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Division of AIDS Data Interchange High Level DAERS Workflow Stop No
Clinical Research Site (CRS)
AE Occurs at CRS
Review EAE submission RCC
DAERS – EAE Reporting
Report to RCC?
Yes
Additional Information Required?
Create EAE
Submit EAE to RCC
Update EAE
Sends Query to CRS
Yes
Archive Report
Notify FDA & CRS
No Yes Assess EAE Report
Additional Information Required?
No No
Safety Report Required?
Yes
Create Safety Report
DAIDS
Last Updated: 9/15/2009
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DAERS (EAE Reporting) Selected Features Division of AIDS Data Interchange 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. Last Updated: 4/7//2010
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Division of AIDS Data Interchange 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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Division of AIDS Data Interchange DAERS Terminology (cont) EAE Report Statuses Pending
Ready for Final Review
An EAE report has been started by the Reporter or Submitter, but it has not been finished.
The EAE report contains all required elements and is ready to be reviewed by the Study Physician.
Submitted to RCC
Withdrawn
The Study Physician has approved and sent the EAE report to RCC.
An EAE Report erroneously submitted to RCC, which is no longer considered an official EAE submission.
Reporter, Submitter or RCC
Status Definition
Email Notification Recipient
To: Reporter for EAE, Study Coordinator
Last Updated: 4/7/2010
To: Reporter for EAE, All Study Physicians on protocol at site, Study Coordinator
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To: RCC, Submitter, Reporter for EAE, All Study Physicians on protocol at site, Study Coordinator, Network’s DMC, and Site’s ICC (where applicable).
To: Reporter or Submitter requesting withdrawal.
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of AIDS Data Interchange DAERSDivision Terminology (cont)
Unique 6 digit number assigned when report is created Indicates the year the report was submitted
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Created
Submitted
Indicates the version of the updated report created
Updated
Indicates the RCCassigned EAE number prior to the migration
Legacy Migrated 9
Division of AIDS Data Interchange 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 12:00 am and ends at 11:59 pm. A day is counted as a reporting day regardless of the time of the day that awareness occurred prior to 11:59 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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of AIDS Data Interchange SubmissionDivision Timelines (cont) Example: Site Awareness: March 13th at 2:00 PM Report Submission Due: March 17th at 11:59 PM
March Sunday
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
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5
6
7
8
9
10
11
12
13 Site
14
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Awareness (2:00pm local time)
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Last Updated: 4/7/2010
Report Due (11:59pm local time )
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of AIDS Data Interchange Past DueDivision Submission Reports that are not submitted within the three reporting days will require an explanation for the delay in submission
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of AIDS Data Interchange SubmissionDivision 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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Division of AIDS Data Interchange 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. Last Updated: 4/7/2010
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Division of AIDS Data Interchange 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
Switch Submitted Initial EAE
Update EAE
EAE Manual Version 1.0
EAE Manual Version 1.0
Created Initial EAE
Submit Initial EAE
EAE Manual Version 1.0
EAE Manual Version 1.0
Create Initial EAE EAE Manual Version 2.0 Last Updated: 4/7/2010
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ofAccount AIDS Data Interchange MaintenanceDivision of User 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: – User’s 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. Last Updated: 4/7/2010
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Division of AIDS Data Interchange Maintenance of User Account Information Site Leaders and Site Coordinators are responsible for maintaining their DAERS User’s 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 site’s organization or is no longer on a protocol, Site Leader or Site Coordinator is responsible for modifying this information.
Last Updated: 3/26/2010
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DAERS Additional Information Division of AIDS Data Interchange Instructions and necessary documents are found on the RCC website http://rcc.techres.com/safetyandpharmacovigilance/
If additional training is required the site should contact DAIDS-ES Support.
[email protected] Last Updated: 4/7/2010
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Division of AIDS Data Information Interchange DAERS Contact
Questions about … DAIDS EAE Manual or DAIDS Reporting Requirements
DAERS
E-Mail:
E-mail:
Phone:
Phone:
Fax:
Fax:
[email protected]
1-800-537-9979 (USA) +1-301-897-1709 (International) 1-800-275-7619 (USA) +1-301-897-1710 (International)
[email protected]
1-866-337-1605 (USA) + 1-240-499-2239 (International) 1-866-337-1606 (USA) + 1-301-948-2242 (International)
When in doubt, copy both. Last Updated: 4/7/2010
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of AIDS Data Interchange Training Division 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 ReportNew!
Additional Features Online Help DAIDS-ES Support
Site Enrollment Module (Site Leaders and Site Coordinators only) New! Submit New Request View Existing Requests
Adding EAE Notification Recipients (Site Leaders and Site Coordinators only) New!
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NIAID, Division of AIDS
Appendix – Changes in DAERS per EAE Manual Version 2.0 by Field
Division of AIDS Data Interchange 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/Protoc ol (Assessment Tool, Study Agents/Vaccine s)
• • • • • •
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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Division of AIDS Data Interchange 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 protocolspecific 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
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