DAIDS Safety Workshop Part III Expedited Reporting via

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DAIDS Safety Workshop: Part III Expedited Reporting via DAERS Albert Yoyin, M. D. and

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 v 2. 0 § DAERS

Objectives § DAERS Overview § New DAERS Features for v 2. 0 § DAERS Usage § Common queries to sites § Case Study 2

DAERS: DAIDS Adverse Experience Reporting System § An integrated module that is part of

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 3

DAERS Overview § DAERS system planning initiated in 2005 § DAERS v 1. 0

DAERS Overview § DAERS system planning initiated in 2005 § DAERS v 1. 0 online Jun 2008 • Updates to the system ~q 6 mos; v 2. 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) 4

New Features in DAERS (v 2. 0 update) DAERS Version 2. 0 was implemented

New Features in DAERS (v 2. 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 5

EAE Reports Submitted by Networks (Jan 2011 – Mar 2012) 5% 10% ACTG 28%

EAE Reports Submitted by Networks (Jan 2011 – Mar 2012) 5% 10% ACTG 28% IMPAACT HPTN HVTN 44% MTN Non-network < 1% 13% Total = 507 6

EAE Reports Submitted by Protocol (Jan 2011 – Mar 2012) 24% 29% PROMISE HPTN

EAE Reports Submitted by Protocol (Jan 2011 – Mar 2012) 24% 29% PROMISE HPTN 052 MTN 003 7% P 1060 12% Others 28% Total = 507 7

Average DAERS Usage (Jan 2011 – Mar 2012) 25% RSC Sites 75% Total =

Average DAERS Usage (Jan 2011 – Mar 2012) 25% RSC Sites 75% Total = 512 8

DAERS Usage by Protocol (Jan 2011 – Mar 2012) 100% 92% 96% 92% 90%

DAERS Usage by Protocol (Jan 2011 – Mar 2012) 100% 92% 96% 92% 90% 75% 80% 70% PROMISE 60% A 5257 50% 41% 40% HPTN 052 MTN 003 30% Others (45) 20% 10% 0% PROMISE A 5257 HPTN 052 MTN 003 Others (45) 9

Non-DAERS Usage § Sites unable to access DAERS • Inability to connect to Internet

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. , P 1020 A and P 1026 s) 10

Late Submissions to RSC § Waiting for additional information (e. g. , discharge summary,

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 11

RSC Queries to Sites 17% 28% Narrative Missing info Primary AE term 19% Reportability

RSC Queries to Sites 17% 28% Narrative Missing info Primary AE term 19% Reportability Other 8% 27% Total = 109 12

Breakdown of RSC Queries to Sites § Narrative (e. g. , medical history/event details;

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, CD 4 count/viral load, enrollment date) § Other (e. g. , PI signature, amending onset date, amending status/status date) 13

Examples of RSC Queries to Sites Ambiguous AE terms which cannot be coded in

Examples of RSC Queries to Sites Ambiguous AE terms which cannot be coded in Med. DRA 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) 14

Case Study: Intrauterine Fetal Demise CASE STUDY TO BE REVIEWED FOR 5 MINUTES 15

Case Study: Intrauterine Fetal Demise CASE STUDY TO BE REVIEWED FOR 5 MINUTES 15

Case Study: Intrauterine Fetal Demise § 6 Jun 2011: 31 year old, HIV infected

Case Study: Intrauterine Fetal Demise § 6 Jun 2011: 31 year old, HIV infected Black female enrolled in 1077 BF (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 mm. Hg, Pulse: 140 bpm, T: 35. 9°C, and Hgb: 9. 5 g/d. L § 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 16

Case Study: Intrauterine Fetal Demise Reporter and Site Information § Site Awareness Date: The

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 17

Case Study: Intrauterine Fetal Demise Timeline for Submission: Must submit within 3 ‘reporting days’

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 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Site Awareness (2 PM local time) 19 20 21 22 23 29 30 24 25 Report Due (11: 59 PM Local Time) 26 27 28 18

Case Study: Intrauterine Fetal Demise Primary Adverse Event § Seriousness Criteria § • Select

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) 19

Case Study: Intrauterine Fetal Demise Primary Adverse Event (cont’d) § Onset Date: The date

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 20

Case Study: Intrauterine Fetal Demise Primary Adverse Event (cont’d) § Status Code at Most

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 21

Case Study: Intrauterine Fetal Demise Case Narrative § Provide information on reported Primary AE

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 22

Case Study: Intrauterine Fetal Demise Study Agent 1 Study Agent 2 • Lopinavir/Ritonavir •

Case Study: Intrauterine Fetal Demise Study Agent 1 Study Agent 2 • Lopinavir/Ritonavir • Lamivudine/Zidovudine 23

Case Study: Intrauterine Fetal Demise Study Agents § Not a free text field §

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 24

Case Study: Intrauterine Fetal Demise Study Agents (cont’d) § Relationship of Study Agent 1

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 25

Case Study: Intrauterine Fetal Demise Study Agents (cont’d) § Exposure to and duration of

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 26

Case Study: Intrauterine Fetal Demise Study Agents (cont’d) § Action Taken: Enter the study

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 27

Case Study: Intrauterine Fetal Demise § Concomitant Medications: • Folic Acid • Ferrous Sulfate

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 28

Case Study: Intrauterine Fetal Demise § Laboratory Tests: • Hemoglobin § Diagnostic Tests: •

Case Study: Intrauterine Fetal Demise § Laboratory Tests: • Hemoglobin § Diagnostic Tests: • Abdominal ultrasonography 29

Teaching Points § Mandatory reporting fields for DAERS does not equal adequate information about

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 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 30

Case Study: Intrauterine Fetal Demise § Reporter: Completes and sends the report for final

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 31

Case Study: Intrauterine Fetal Demise UPDATE 32

Case Study: Intrauterine Fetal Demise UPDATE 32

Case Study: Intrauterine Fetal Demise Primary Adverse Event § Status Code at Most Recent

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 33

Case Study: Intrauterine Fetal Demise Submission of UPDATE § Completion Check to put the

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 34

How to Report to DAIDS Reports must be submitted via DAERS: § DAERS via

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: DAIDSRSCSafety. [email protected] com – If e-mailing, scan or FAX signature page 35

Confirmation of Receipt § DAERS will send a confirmation e-mail for all SAE reports

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 36

Where to Get Help § RSC Safety Office: • E-mail: DAIDSRSCSafety. Office@tech-res. com •

Where to Get Help § RSC Safety Office: • E-mail: DAIDSRSCSafety. [email protected] com • 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] nih. gov • Telephone: +1 -240 -499 -2239 or 1 -866 -337 -1605 (USA only) • FAX: +1 -301 -948 -2242 37

Questions? 38

Questions? 38