DAIDS Safety Workshop: Part III Expedited Reporting via DAERS Albert Yoyin, M.D. and Archita Chatterjee, M.S. DAIDS RSC Safety Office Johannesburg, South.

DAIDS Safety Workshop: Part IIIExpedited Reporting via DAERS

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

Albert Yoyin, M.D. and Archita Chatterjee, M.S.DAIDS RSC Safety Office

Johannesburg, South Africa29 Aug 2012

ObjectivesObjectives

DAERS Overview

New DAERS Features for v2.0

DAERS Usage

Common queries to sites

Case Study

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DAERSDAERS

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 OverviewDAERS 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)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)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)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)Average DAERS Usage(Jan 2011 – Mar 2012)

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25%

75%

RSCSites

Total = 512

DAERS Usage by Protocol(Jan 2011 – Mar 2012)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 UsageNon-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 RSCLate 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 RSC Queries to Sites

28%

27%8%

19%

17%

NarrativeMissing infoPrimary AE termReportabilityOther

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Total = 109

Breakdown of RSC Queries to SitesBreakdown 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 SitesExamples 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 DemiseCase Study: Intrauterine Fetal Demise

CASE STUDY TO BE REVIEWED FOR 5 MINUTES

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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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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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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 4

5 6 7 8 9 10 11

12 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)


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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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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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 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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•Lopinavir/Ritonavir

Study Agent 1

•Lamivudine/Zidovudine

Study Agent 2

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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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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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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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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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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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Laboratory Tests:

• Hemoglobin

Diagnostic Tests:

• Abdominal ultrasonography

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Teaching PointsTeaching 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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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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UPDATE


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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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 DAIDSHow 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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https://daidses.niaid.nih.gov/Phoenix

mailto:[email protected]

Confirmation of ReceiptConfirmation 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 HelpWhere 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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https://rsc.tech-res.com/


Questions?

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DAIDS Safety Workshop: Part III Expedited Reporting via DAERS Albert Yoyin, M.D. and Archita Chatterjee, M.S. DAIDS RSC Safety Office Johannesburg, South.

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