Transcript Safety Workshop Part III - DAERS

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
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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)
5%
10%
28%
44%
< 1%
ACTG
IMPAACT
HPTN
HVTN
MTN
Non-network
13%
Total = 507
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EAE Reports Submitted by Protocol
(Jan 2011 – Mar 2012)
24%
29%
7%
12%
PROMISE
HPTN 052
MTN 003
P1060
Others
28%
Total = 507
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Average DAERS Usage
(Jan 2011 – Mar 2012)
25%
RSC
Sites
75%
Total = 512
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DAERS Usage by Protocol
(Jan 2011 – Mar 2012)
100%
92%
96%
92%
90%
80%
75%
70%
PROMISE
A5257
HPTN 052
MTN 003
Others (45)
60%
50%
41%
40%
30%
20%
10%
0%
PROMISE
A5257
HPTN 052
MTN 003
Others (45)
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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
17%
29%
Narrative
Missing info
Primary AE term
Reportability
Other
19%
8%
27%
Total = 109
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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
hospitalization
The 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
June 2011
Sunday
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
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Site
Awareness
(2 PM
local time)
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Report Due
(11: 59 PM
Local Time)
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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
Study
Agent 1
• Lopinavir/Ritonavir
Study
Agent 2
• Lamivudine/Zidovudine
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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 Criteria
Primary AE
Severity Grade
Onset Date
Status Code
Status Date
Narrative
Study 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
UPDATE
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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:
 DAIDS-ES Support:
https://rsc.tech-res.com
•
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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