daids safety workshop: part iii expedited reporting via daers
DESCRIPTION
DAIDS Safety Workshop: Part III Expedited Reporting via DAERS. Albert Yoyin, M.D. and Archita Chatterjee, M.S. DAIDS RSC Safety Office Johannesburg, South Africa 29 Aug 2012. Objectives. DAERS Overview New DAERS Features for v2.0 DAERS Usage Common queries to sites Case Study. DAERS. - PowerPoint PPT PresentationTRANSCRIPT
DAIDS Safety Workshop: Part IIIExpedited Reporting via DAERS
Albert Yoyin, M.D. and Archita Chatterjee, M.S.DAIDS RSC Safety Office
Johannesburg, South Africa29 Aug 2012
Objectives
DAERS Overview New DAERS Features for v2.0 DAERS Usage Common queries to sites Case Study
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DAERS
DAERS: DAIDS Adverse Experience Reporting System An integrated module that is part of the DAIDS
Enterprise System (DAIDS-ES) A secure, confidential, web-based system through which
sites are required to submit expedited reports to DAIDS For sites where DAERS has been implemented, all SAEs
and supporting information will be submitted to DAIDS using the DAERS, unless the system is unavailable for technical reasons• Use DAIDS EAE Reporting Form if DAERS is not implemented
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DAERS Overview
DAERS system planning initiated in 2005 DAERS v1.0 online Jun 2008
• Updates to the system ~q6 mos; v2.0 as of Jun 2012
DAERS Integration Group (DIG) meets regularly to address current technical issues and system changes• SMEs (DAIDS MOs, SPT, and RSC personnel) provide
input to DAIDS-ES programmers• Monthly calls with all collaborators group (site personnel,
DMCs, network representatives)
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New Features in DAERS (v2.0 update)
DAERS Version 2.0 was implemented on 22 Jun 2012
Site-specific features:• Make specific fields (such as severity grade, status code,
and status date) optional if event is not an SAE but is required to be reported to DAIDS, or is of sufficient concern to warrant informing DAIDS
• Date of death field added; only required when the event being submitted indicates “Death”; otherwise field is disabled/grayed out
• Force change of status date when changing status code/outcome for update reports
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EAE Reports Submitted by Networks(Jan 2011 – Mar 2012)
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10%
44%
13%< 1%
28%
5%
ACTGIMPAACTHPTNHVTNMTNNon-network
Total = 507
EAE Reports Submitted by Protocol(Jan 2011 – Mar 2012)
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Total = 507
29%
12%
28%
7%
24%
PROMISEHPTN 052MTN 003P1060Others
Average DAERS Usage(Jan 2011 – Mar 2012)
8
25%
75%
RSCSites
Total = 512
DAERS Usage by Protocol(Jan 2011 – Mar 2012)
PROMISE A5257 HPTN 052 MTN 003 Others (45)0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100% 92%96%
92%
41%
75%
Column1
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Non-DAERS Usage
Sites unable to access DAERS• Inability to connect to Internet• DAERS system unavailable (e.g., down for maintenance)• Site personnel not authorized to access DAERS (e.g.,
have not taken DAERS training; no Physician Electronic Signature Attestation Form received for submitter)
• Site personnel unable to access DAERS (e.g., forgot password)
Sites reporting on older “SAE” reporting category protocols (e.g., P1020A and P1026s)
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Late Submissions to RSC
Waiting for additional information (e.g., discharge summary, lab reports, etc.)
Reportability (e.g., questions regarding the reportability of an event; sites unaware that multiple reports are required when multiple Primary AEs were identified)
System access (e.g., inability to connect to the Internet or to DAERS)
SAE was overlooked as needing to be reported No back-up submitter available
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RSC Queries to Sites
28%
27%8%
19%
17%
NarrativeMissing infoPrimary AE termReportabilityOther
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Total = 109
Breakdown of RSC Queries to Sites
Narrative (e.g., medical history/event details; AE status/resolution; treatment/management for AE)
Reportability (e.g., justification for ICH SAE criteria, severity grade, and/or relationship assessment)
Primary AE term (e.g., reporting ambiguous terms or multiple AEs in one term; ICH SAE criteria as AEs)
Missing info (e.g., source documents, con meds, CD4 count/viral load, enrollment date)
Other (e.g., PI signature, amending onset date, amending status/status date)
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Examples of RSC Queries to Sites
Ambiguous AE terms which cannot be coded in MedDRA
The reporting of “hospitalization” as an adverse event instead of reason for hospitalizationThe reporting of “death” as an adverse event instead of cause of death
Wrong dates (e.g., DOB, awareness, start) inconsistent with narrative
Errors in the selection of the SAE criteria (e.g. life-threatening anemia but assigned as Grade 2)
Accurate information about study drugs (e.g. dose, schedule, start and stop dates)
Missing information (e.g. lab results, diagnostic test results, con meds, supporting information such as progress notes, death certificates)
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Case Study: Intrauterine Fetal Demise
CASE STUDY TO BE REVIEWED FOR 5 MINUTES
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Case Study: Intrauterine Fetal Demise
6 Jun 2011: 31 year old, HIV infected Black female enrolled in 1077BF (PROMISE)
17 Jun 2011: subject was ~ 20 wks. pregnant and presented to the hospital with lower abdominal pain (Grade 2), vaginal bleeding (Grade 2), and abdominal contractions
BP: 142/72 mmHg, Pulse: 140 bpm, T: 35.9°C, and Hgb: 9.5 g/dL
US confirmed no fetal heartbeat and no liquor Later on the same day, the subject’s fetus was expelled;
the placenta and membranes were noted as healthy and complete
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Case Study: Intrauterine Fetal Demise
Reporter and Site Information Site Awareness Date: The date the site first became aware
of the adverse event occurring at a reportable level• Date adverse event (AE) occurred
– 17 Jun 2011• Date serious adverse event (SAE) occurred
– 17 Jun 2011• Date site aware event occurred at a reportable level
– 17 Jun 2011
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Case Study: Intrauterine Fetal Demise
Timeline for Submission: Must submit within 3 ‘reporting days’ of site awareness
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Sunday Monday Tuesday Wednesday Thursday Friday Saturday
1 2 3 45 6 7 8 9 10 1112 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28 29 30
Report Due (11: 59 PM Local Time)
June 2011
Site Awareness(2 PM local time)
Case Study: Intrauterine Fetal Demise
Primary Adverse Event Seriousness Criteria
• Select appropriate ICH-SAE criteria• More than one criteria can be selected• Requires inpatient hospitalization or prolongation of
existing hospitalization Primary Adverse Event
• Intrauterine fetal demise Severity Grade
• Grade 3 (Severe)
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Case Study: Intrauterine Fetal Demise
Primary Adverse Event (cont’d) Onset Date: The date the primary adverse event first
occurred at the level requiring expedited reporting• 17 Jun 2011
Country of AE Origin: The country where the event occurred; may not necessarily be where the site is located• South Africa
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Case Study: Intrauterine Fetal Demise
Primary Adverse Event (cont’d) Status Code at Most Recent Observation: The status
code of the subject at the most recent observation• Recovering/Resolving
Status Date: Date of the most recent observation of the subject• Date should be on or after the site awareness date
– Date of most recent observation for subject status can be at or after the site is aware of the occurrence of the event
• 17 Jun 2011
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Case Study: Intrauterine Fetal Demise
Case Narrative Provide information on reported Primary AE Describe:
• clinical course• therapeutic measures• outcome• relevant past medical history• concomitant medication(s)• alternative etiologies• any contributing factors• all other relevant information
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Case Study: Intrauterine Fetal Demise
•Lopinavir/Ritonavir
Study Agent 1
•Lamivudine/Zidovudine
Study Agent 2
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Case Study: Intrauterine Fetal Demise
Study Agents Not a free text field Choose study agent from drop down menu of
smart text field• Study Agent 1: Lopinavir/Ritonavir• Study Agent 2: Lamivudine/Zidovudine
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Case Study: Intrauterine Fetal Demise
Study Agents (cont’d) Relationship of Study Agent 1 to Primary AE
• Related Dose and Unit of Measurement
• 200/50 mg Date of First Dose
• 6 Jun 2011 Date of Last Dose: The date the subject took the last
dose prior to the onset of the adverse event• 16 Jun 2011
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Case Study: Intrauterine Fetal Demise
Study Agents (cont’d) Exposure to and duration of use of study agent
is important information to assess the case Ensure accuracy of information If unsure, please notate that the date is
estimated
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Case Study: Intrauterine Fetal Demise
Study Agents (cont’d) Action Taken: Enter the study physician’s action taken
with the study agent after awareness of the SAE• Continued without change
Action Date: Date has to be on or after the site awareness date, i.e., study physician can take action with the study agent only after the site is aware the AE has occurred at a reportable level• 17 Jun 2011• If action taken is “Course completed or Off Study Agent at AE
Onset,” action taken can be left blank
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Case Study: Intrauterine Fetal Demise
Concomitant Medications:• Folic Acid• Ferrous Sulfate• Amoxicillin
Other Events: List other clinically significant signs and symptoms that more fully describe the nature, severity, and/or complications of the Primary AE• Abdominal Pain• Vaginal Bleeding
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Case Study: Intrauterine Fetal Demise
Laboratory Tests:• Hemoglobin
Diagnostic Tests:• Abdominal ultrasonography
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Teaching Points
Mandatory reporting fields for DAERS does not equal adequate information about the case • Not just what the system (i.e., DAERS) requires as
mandatory fields: Participant ID Site ID Protocol ID
Protocol version Site Awareness date SAE CriteriaPrimary AE Severity Grade Onset Date Status Code Status Date NarrativeStudy Agent/Product Relationship Dosing details
Other events Reporter name Reporter E-mail
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Case Study: Intrauterine Fetal Demise
Reporter: Completes and sends the report for final review
Submitter: Reviews and submits the Report to DAIDS
E-mail notification of expedited report submission sent to CRS staff and other key stakeholders
Site responsibility to ascertain that the report was, in fact, submitted
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Case Study: Intrauterine Fetal Demise
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UPDATE
Case Study: Intrauterine Fetal Demise
Primary Adverse Event Status Code at Most Recent Observation:
• Recovered/Resolved Status Date: Date of the most recent observation of the
subject• 20 Jun 2011
Case Narrative• 18 Jun 2011: discharged from hospital• 20 Jun 2011: evaluated in study clinic
Additional Information• Upload discharge summary
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Case Study: Intrauterine Fetal Demise
Submission of UPDATE Completion Check to put the EAE Report in “Ready for
Final Review Status” Click “View PDF Report” to verify your edits have been
made• Update status code and status date• Update case narrative• Additional Information
Submitter will review the report and Submit through DAERS
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How to Report to DAIDS
Reports must be submitted via DAERS: DAERS via web: https://daidses.niaid.nih.gov/Phoenix For emergency use only:
• FAX: +1-301-897-1710
or 1-800-275-7619 (USA only)
• E-mail: [email protected]– If e-mailing, scan or FAX signature page
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Confirmation of Receipt
DAERS will send a confirmation e-mail for all SAE reports
It is the site’s responsibility to follow up if they do not receive a confirmation e-mail
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Where to Get Help
RSC Safety Office:• E-mail: [email protected]• Telephone: +1-301-897-1709
or 1-800-537-9979 (USA only)• FAX: +1-301-897-1710
or 1-800-275-7619 (USA only)
RSC Website: https://rsc.tech-res.com
DAIDS-ES Support:• E-mail: [email protected]• Telephone: +1-240-499-2239
or 1-866-337-1605 (USA only)• FAX: +1-301-948-2242
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Questions?
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