Otsuka Data Entry Convention (DEC) Version 12.0 PDF

Approval Document Title : AVISSO_v8.2_DEC Doc. No. : GSD-GLB-COMP-2022-0045-00027.001 Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-202...

Approval Document Title : AVISSO_v8.2_DEC Doc. No. : GSD-GLB-COMP-2022-0045-00027.001 Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Approval Approver Functional Role Approved On Reason For Esign Nipa Parikh Business Owner 18-Oct-2023 11:20:43 AM Approval [[email protected]] Time Zone: (EDT) Vikalp Khare System Owner 19-Oct-2023 12:29:21 AM Approval [[email protected]] Time Zone: (EDT) X Otsuka Data Entry Convention Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Otsuka Data Entry Convention (DEC) Oracle Argus Safety Database Version 12.0 Effective Date: 30-OCT-2023 `  Argus DEC V12.0 Guide Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Overview X Overview Document Purpose This document provides a guideline for entering data into each field that is found on the Oracle Argus Safety System interface. Document Summary The document is presented per Tab, or screen, that is found in Argus and is further broken down by section within the tab. Each tab in this document represents a Tab, or screen, in Argus. For each field, the following information is presented, across in each column: Field Name Field Name as it displays in the interface Field Type Type of data accepted by the field. See below / next page for types and descriptions. Field Value(s) Configured values are listed, unless the list is too long such as for Countries Instructions Instructions for how to enter data for the field MedWatch and CIOMS Mapping If the value will display on a MedWatch or CIOMS form, the report field is noted, else "No Mapping" If the value will be transmitted via E2B, the E2B Data Element and DTD Descriptor will be referenced, else E2B Mapping "No Mapping" Additional Comments Extra explanation regarding how to use or enter data into the field Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 2 of 154  Argus DEC V12.0 Guide Signature Page X Author Role Printed Name/Title D. Petrazzuoli, Business Consultant / Safety Data Management Author Consultant Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Reviewed by Meaning of Signature – Reviewers Signature by the reviewers indicates to a high degree of assurance that they have read, understood, and agree that the sections and content of the document that are pertinent to their functional or technical expertise are accurate and complete. Role Printed Name Comments Associate Director, Safety Data Management, Shivangi Kachalia Electronic signature in eVLMS GPV Safety Data Manager, Safety Data Masayo Yamashita Electronic signature in eVLMS Management, GPV Senior Manager, Case Management, GPV Purvi Suthar Electronic signature in eVLMS Case Processing PV Operations, Case Processing Chief, GPV Akiko Oshima Electronic signature in eVLMS PV Operations Manager, GPV Mari Shintani Electronic signature in eVLMS Approved by Meaning of Signature — Approvers Signature by the approvers indicates to a high degree of assurance that they have read and understood the content of the document, that they agree the document is complete and accurate, and that they support its intent. Role Printed Name Comments Executive Director, Global PV Strategy & Nipa Parikh Electronic signature in eVLMS Operations, GPV Strategic Management OPDC Director, Safety Data Management, GPV Vikalp Khare Electronic signature in eVLMS Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 3 of 154  Argus DEC V12.0 Guide Table of Contents Table of Contents Tab Name Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) 1 Cover 2 Overview 3 Signature Page 4 Revision History 5 Summary of Revisions 6 Initial Case Entry & Dup Search 7 Incoming E2B Reports 8 General Tab 9 Patient Tab 10 Products Tab 11 Events Tab 12 Analysis Tab 13 Activities Tab 14 Additional Info Tab 15 Regulatory Reports Tab 16 Medical Review 17 Case Delete & Undelete 18 End of Study 19 Field Values 20 Narrative Templates-Statements 21 Additional References 22 Additional Resources (Link) Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 4 of 154  Argus DEC V12.0 Guide Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Revision History X Revision History Version Date Author Description / Impact to Document D. Petrazzuoli, Business Consultant / Safety Data Management 1.0 19-Nov-14 Initial Document Consultant Carol Hecht / Senior Clinical Safety Associate, Clinical Safety and Approval Date Pharmacovigilance Revised document/ See Summary of 2.0 Paridhi Anand/ Clinical Safety Associate, Clinical Safety and from GQEDMS Revisions section Pharmacovigilance Approval Date Paridhi Anand/ Clinical Safety Associate, Clinical Safety and Revised document/ See Summary of 3.0 from GQEDMS Pharmacovigilance Revisions section Approval Date Paridhi Anand/ Senior Associate, Clinical Safety and Revised document/ See Summary of 4.0 from GQEDMS Pharmacovigilance Revisions section Approval Date Paridhi Anand/ Senior Associate, Clinical Safety and Revised document/ See Summary of 5.0 from GQEDMS Pharmacovigilance Revisions section Approval Date Fazleabbas Poonawala/ Senior Associate, Global Revised document/ See Summary of 6.0 from GQEDMS Pharmacovigilance Revisions section Approval Date Ravi Patel/ Manager Global Submissions, Global Revised document/ See Summary of 7.0 from GQEDMS Pharmacovigilance Revisions section Approval Date Dennis Belov/ Associate, Global Pharmacovigilance Revised document/ See Summary of 8.0 from GQEDMS Revisions section Approval Date Sumit Narang/ Senior Associate, Global Pharmacovigilance Revised document/ See Summary of 9.0 from GQEDMS Revisions section Approval Date Mayuri Patel/ Senior Associate, PV Operations GPV Case Revised document/ See Summary of 10.0 from GQEDMS Processing Revisions section Approval Date Ruchika Udainiya/ Drug Safety Associate, GPV Case Processing Revised document/ See Summary of 11.0 from GQEDMS Revisions section Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 5 of 154  Argus DEC V12.0 Guide Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Revision History Version Date Author Description / Impact to Document ALVIS Revision History Resetting the document revision history to version 001 as part of managing the document in ALVIS. Legacy document ID from GQ-EDMS Nnenna Ezealor/ Manager, Case Management, GPV Case is VAL-0011130. 001 13-Oct-23 Processing Version 12.0 Revised document/ See Summary of Revisions section Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 6 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Summary of Revisions X Tab Field Name Revision Revision 2.0 dated 13-Nov-2015 Initial Case Entry and Duplicate PV Receipt date UPDATE: Instructions field updated Search Tab Initial Case Entry and Duplicate Description As Reported UPDATE: Instructions field updated Search Tab Initial Case Entry and Duplicate Classification (Attachments and References Sub-Section) UPDATE: Additional Comments Search Tab Initial Case Entry and Duplicate Description (Attachments and References Sub-Section) UPDATE: Help field updated Search Tab General Tab Initial/Follow up Source Justification NEWLY ADDED: Additional selectable field, mandatory requirement to add supplier of source document General Tab Classification UPDATE: Field Value(s) "Country" corrected to "Invalid Case" General Tab State/Province UPDATE: Instructions field updated General Tab Report Type REMOVED: Regulatory Authority Field Value removed General Tab Classification UPDATE: Instructions for field values Measures Report, Research Report and J-Reportable updated General Tab Initial/Follow up Receipt Date UPDATE: Help field updated General Tab Initial/Follow up PV Receipt Date UPDATE: Instructions and help field updated General Tab Reporter Information UPDATE: General instruction field updated General Tab Health Care Professional UPDATE: Help field updated - is this help field text accurate? General Tab Reporter Type UPDATE: Removed "other Non-HCP" and updated to "Other" Patient Tab Lab Data UPDATE: To verbatim, test name and notes Patient Tab Protect Confidentiality UPDATE: Instructions and help field corrected and clarified Patient Tab Age UPDATE: Instructions field updated Patient Tab Gender UPDATE: Instructions field updated Product Tab Suspect / Concomitant / UPDATE: Instructions field updated Treatment Product Tab Device Sub-Tab NEWLY ADDED: Multiple fields updated to reflect the data entry requirements for device handling Product Tab Action Taken UPDATE: Instructions field updated Product Tab Model# UPDATE: Instructions field updated Product Tab Serial# UPDATE: Instructions field updated Product Tab Catalog# UPDATE: Instructions field updated Product Tab Product name UPDATE: Instruction field updated "If a product is not available to be coded in the CDD dictionary, a request must be sent to have the product added. " Product Tab Dechallenge/Rechallenge UPDATE: Instruction and help fields updated Product Tab Dosage Information UPDATE: Help field updated Product Tab Patient Route of Administration UPDATE: Instructions updated Events Tab As Reported Causality UPDATE: Causality mapping for causality received as “unlikely” and “doubtful” in spontaneous and clinical settings added Events Tab As Determined Causality UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Events Tab General Event Information UPDATE: General instruction field updated Events Tab Term Highlighted by Reporter NEWLY ADDED: Help information added Events Tab Infection check box JAPAN USE ONLY - should update without having to send to Global for correction Analysis Tab Company Comment UPDATE: Instruction and help fields updated Analysis Tab Narrative UPDATE: Instruction and help fields updated Medical Review As Determined Causality UPDATE: Instruction and help fields updated Medical Review Company Comment UPDATE: Instruction and help fields updated Medical Review Narrative UPDATE: Instruction and help fields updated Additional Info Tab References (Type) NEWLY ADDED: Field Value(s) added Additional Info Tab Notes and Attachments NEWLY ADDED: Keywords Field added, required Additional Info Tab Incl. Reg. Sub NEWLY ADDED: Instruction field updated Activities Tab Contact Logs NEWLY ADDED, UPDATE and REMOVAL: Added additional contact log types and Instruction for use. Removed "pregnancy form, NDA Safety Letter and Safety Information Report Form" Activities Tab Action Item UPDATE: Instruction field updated Narrative Templates-Statement Narrative Templates NEWLY ADDED: New tab provides template language, examples of open and closing statements Additional References Additional references NEWLY ADDED: Added information regarding handling E2B Cases, Splitting Cases, Partner Cases Additional Resources Additional Resources NEWLY ADDED: List of additional documents and location for supplemental information Revision 3.0 dated 13-Jun-2015 All Tabs N/A Removed column "Cover in Training" Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 7 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision All Tabs N/A Removed column "Req" All Tabs N/A Removed column "Help Text" Initial Case Entry and Duplicate Source Justification UPDATE: New Source Justifications added Search Tab Initial Case Entry and Duplicate Literature Reference - ID UPDATE: Added instructions Search Tab Initial Case Entry and Duplicate Reported Causality UPDATE: Added instructions Search Tab General Tab Follow-up Information UPDATE: Additional Comments field updated General Tab Significant UPDATE: Instructions field updated General Tab Initial/Follow-up Source Justification UPDATE: Additional Source Justifications Added General Tab Health Care Professional UPDATE: Additional Comments field updated General Tab Occupation UPDATE: Additional Field Values added and Additional Comments field updated General Tab Country of Incidence UPDATE: Additional Comments field updated General Tab Protect Confidentiality UPDATE: Additional Comments field updated Patient Tab Other Relevant History - Indication UPDATE: Additional Comments field updated Product Tab Obtain Drug Country UPDATE: Additional Comments field updated Product Tab Drug Authorization Country NEWLY ADDED: Newly added instructions for this field Product Tab Stop Date UPDATE: Instructions field updated Product Tab Action Taken UPDATE: Instructions field updated Product Tab Action Taken UPDATE: Additional Field Value added Product Tab Product Notes UPDATE: Instructions field updated Product Tab Operator of Device UPDATE: Instructions field updated Product Tab Malfunction UPDATE: Instructions field updated Product Tab Manufacturer/Importer Awareness Date UPDATE: Instructions field updated Product Tab Device Available for Evaluation UPDATE: Instructions field updated Product Tab Returned to Manufacturer UPDATE: Instructions field updated Product Tab Device Evaluated by Manufacturer UPDATE: Field Value updated Product Tab EU/CA Device Tab Multiple fields updated under this tab Events Tab Descriptions as Reported UPDATE: Instructions field updated Events Tab Onset Date UPDATE: Additional Comments field updated Events Tab Event Receipt Date UPDATE: Additional Comments field updated Events Tab Severity UPDATE: Field Values added Events Tab Associated with Rechallenge UPDATE: Additional Comments field updated Events Tab Related to Study Conduct? (As Reported) UPDATE: Additional Field Value instructions added Events Tab Events Assessment - Recalculate UPDATE: Additional Comments field updated Events Tab Medically Significant UPDATE: Additional Comments field updated Events Tab As Reported Causality UPDATE: Additional Comments field updated Events Tab As Determined Causality UPDATE: Additional Comments field updated Events Tab As Determined Listedness UPDATE: Additional Comments field updated Analysis Tab Narrative UPDATE: Instructions field updated Analysis Tab Flag Icon NEWLY ADDED: Instructions added for new field Analysis Tab Future actions UPDATE: Instructions field updated Analysis Tab AFSSaPS Info sub-tab UPDATE: Instructions added for multiple fields Activities Tab Contact Log - Group UPDATE: Instruction field updated Additional Info Tab Classification UPDATE: Field Value Added Additional Info Tab Incl. Reg. Sub UPDATE: Instruction field updated Additional Info Tab References (Type) NEWLY ADDED: Field Value(s) added Medical Review [Datasheet] UPDATE: Field value added Medical Review As Determined Listedness UPDATE: Additional Comments field updated Narrative Templates-Statement Narrative Templates UPDATE: Additional instructions provided for narrative template, additional closing statements and additional closing statement for Literature cases Additional References Additional references UPDATED: Permitted exceptions to partner cases; splitting cases Additional Resources Additional Resources UPDATE: Location of supplemental information Event Labeling Guidance Event Labeling Guidance UPDATE: removal of JP-IB Event Labeling Guidance Event Labeling Guidance UPDATE: inclusion of details regarding the use of a Non-Otsuka IB Revision 4.0 dated 12-May-2017 Initial Case Entry and Duplicate Initial Source Justification UPDATE: New Source Justifications added Search Tab General Tab Follow-up Source Justification UPDATE: New Source Justifications Added General Tab Study ID UPDATE: Additional Comments field updated General Tab Study Name UPDATE: Additional Comments field updated General Tab Other ID UPDATE: Additional Comments field updated General Tab Study Type UPDATE: Additional Comments field updated General Tab Study Description UPDATE: Additional Comments field updated General Tab Literature Information UPDATE: General information General Tab Reporter Type UPDATE: Additional Comments Field updated Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 8 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision Patient Tab Patient Initials UPDATE: Instructions field updated Products Tab Product Name UPDATE: Additional Comments field updated Products Tab Device Specific Sub-Tab UPDATE: Two new fields were added (Patient Problem code and Device Problem Code) Products Tab Improper Use or Storage UPDATE: Instructions field updated Products Tab Expected Date of Follow-Up UPDATE: Instructions field updated Products Tab Investigation Result UPDATE: Instructions field updated Events Tab Event Receipt Date UPDATE: Additional Comments field updated Events Tab Outcome UPDATE: Additional Comments field updated Events Tab Date of Death UPDATE: Additional Comments field updated Events Assessment Tab Datasheet UPDATE: Field value removed and Additional Comments field updated Events Assessment Tab As Determined Listedness UPDATE: Instructions and Additional Comments field updated Analysis Tab Reporter's Comment UPDATE: Field Name change and Instructions field updated Activitites Tab Custom Letter Template UPDATE: Additional letter templates added Additional Info Tab References (Type) UPDATE: Additional Reference Types added Regulatory Reports Tab Destination UPDATE: Additional Comments updated Regulatory Reports Tab General Headings UPDATE: General table headings updated to state "FOR SUBMISSION USE ONLY" Regulatory Reports Tab Schedule New Report UPDATE: Instructions field updated Regulatory Reports Tab Auto Schedule UPDATE: Instructions field updated Regulatory Reports Tab Generated UPDATE: Instructions field updated Regulatory Reports Tab Approved UPDATE: Instructions field updated Regulatory Reports Tab Submitted UPDATE: Instructions field updated Regulatory Reports Tab New Data Available UPDATE: Instructions field updated Medical Review Tab As Determined Causality UPDATE: Additional Comments updated Medical Review Tab As Determined Listedness UPDATE: Instructions field updated Revision 5.0 dated 22-Nov-2017 Initial Case Entry and Duplicate Initial Source Justification UPDATE: New Source Justifications added Search Tab General Tab Follow-up Source Justification UPDATE: New Source Justifications Added General Tab Country of Incidence UPDATE: Additional Comments updated (R3) Patient Tab Pat ID UPDATE: Additional Comments updated Patient Tab Age Group UPDATE: Field Values added and Additional Comments updated (R3) Patient Tab Weight UPDATE: Additional Comments updated (R3) Patient Tab Height UPDATE: Additional Comments updated (R3) Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 9 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision Patient Tab Concomitant Therapy NEW FIELD added in the patients tab Patient Tab/ Parent Sub-Tab Age Units UPDATE: Additional Comments updated Products Tab Strength NEW FIELD added in the products tab Products Tab Strength Unit NEW FIELD added in the products tab Products Tab Study Drug Not Administered UPDATE: Additional Comments updated (R3) Products Tab Drug Not Administered NEW FIELD added in the products tab Products Tab Product Notes UPDATE: Instructions + Additional Comments updated (R3) Products Tab Dechallenge Results UPDATE: Additional Comments updated Events Tab Medical Confirmation NEW FIELD added in the events tab Events Tab Identification of Country Where Event Happened NEW FIELD added in the events tab Analysis Tab Company Comment (German Language) NEW FIELD for COI Switzerland Additional Info Tab Classification UPDATE: Field Values + Instructions update Additional Info Tab Incl. Reg. Sub UPDATE: Instructions Additional Info Tab Attach File UPDATE: Additional Comments Additional Info Tab References (Type) UPDATE: Field Values Regulatory Reports Tab Destination UPDATE: Additional Comments Regulatory Reports Tab Responsible UPDATE: Instructions Regulatory Reports Tab Remove Report UPDATE: Instructions Regulatory Reports Tab Routing Tab/ Date Time UPDATE: Instructions Regulatory Reports Tab Routing Tab/ User UPDATE: Instructions Regulatory Reports Tab Submissions Tab/ Submission Required UPDATE: Instructions + Additional Comments Regulatory Reports Tab Submissions Tab/ Determined On UPDATE: Instructions Regulatory Reports Tab Submissions Tab/ Determined By UPDATE: Instructions Medical Review Tab Company Comment (German Language) NEW FIELD for COI Switzerland Narrative Templates-Statement Post Marketing and Clinical Trial Narrative Templates added Narrative Templates-Statement Digital Object Identification # for literature cases Narrative Templates-Statement Company Comment for COI Switzerland Cases Narrative Templates-Statement AOSE Template Text Narrative Templates-Statement Local Swiss Label Assessment Revision 6.0 dated 22-Jun-2018 Activities Tab Case Deletion UPDATE: Instructions Additional References N/A UPDATE: Case splitting instructions removed Additional Info Tab Incl. Reg. Sub UPDATE: Instructions formatting Additional Info Tab References (Type) UPDATE: Additional field values added Analysis Tab (PMDA Info sub-tab) Follow Up Receipt Date UPDATE: Instructions Analysis Tab (PMDA Info sub-tab) Date FU Rcvd By Safety Department UPDATE: Instructions Analysis Tab (PMDA Info sub-tab) Significant UPDATE: Instructions Analysis Tab (PMDA Info sub-tab) Japan Initial Receipt Date UPDATE: Instructions, Additional Comments Analysis Tab (PMDA Info sub-tab) Japan Follow-Up Receipt Date UPDATE: Instructions, Additional Comments Analysis Tab (PMDA Info sub-tab) Complete Case UPDATE: Instructions Analysis Tab (PMDA Info sub-tab) Reason for Incompleteness UPDATE: Instructions Event Tab Onset date/ time UPDATE: Additional comments Event Tab Dropped from study UPDATE: Additional comments Event Tab Listedness UPDATE: Additional Comments Event Labeling Guidance N/A UPDATE: Additional Guidance Added General tab Classification UPDATE: Additional field values added General Tab Justification UPDATE: Additional field values added Medical Review As Determined Listedness UPDATE: Additional Comments Patient tab Age Group UPDATE: Additional Comments Patient tab Gender UPDATE: Additional Comments Patient tab Ethnicity UPDATE: Additional field values added Patient tab Initials UPDATE: Additional comments Products Tab Product Name UPDATE: Additional comments formatting Products Tab Start Date/Time UPDATE: Additional Comments Products Tab If no, provide reason UPDATE: Instructions formatting Products Tab Daily Dosage UPDATE: Additional comments Revision 7.0 dated 11-Feb-2019 Initial Case Entry and Duplicate UPDATE: Instructions, Field value removed Search Tab Report type Initial Case Entry and Duplicate UPDATE: Instructions, Field value removed Search Tab Source Justification Initial Case Entry and Duplicate State/Province UPDATE: Instructions Search Tab Initial Case Entry and Duplicate Patient Gender UPDATE: Field value removed Search Tab Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 10 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision General Tab State/Province UPDATE: Instructions General Tab Report type UPDATE: Instructions, Field value removed General Tab Source Justification UPDATE: Instructions, Field value removed General Tab Country UPDATE: Instructions General Tab Classification UPDATE: Instructions General Tab Email address UPDATE: Instructions General Tab Title/Literature section UPDATE: Instructions Patient Tab Patient Gender UPDATE: Field value removed Patient Tab Age Group UPDATE: Instructions Patient Tab Patient Notes UPDATE: Instructions Patient Tab Concomitant Therapy UPDATE: Instructions Patient Tab Relevant Tests UPDATE: Instructions Patient tab Lab Data/ Date UPDATE: Instructions Events Tab Identification of Country Where Event Occurred UPDATE: Instructions Events Tab Term Highlighted by Reporter UPDATE: Instructions Events Tab As Reported Causality UPDATE: Instructions Events tab Reporter's Seriousness NEW FIELD for COI Japan Events Tab Description as reported UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Events Tab Hospitalized UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Events Tab Medically significant UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Events Tab As Reported Causality UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Events Tab As Determined Causality UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Events Tab As Determined Listedness UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Medical Review As Reported Causality UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Medical Review As Reported Causality UPDATE: Instructions Medical Review As Determined Causality UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Medical Review As Determined Listedness UPDATE: Change in wording for special scenarios to special situations (not sentinel events) Activities Tab Action Item/User UPDATE: Instructions Activities Tab Routing/Return UPDATE: Instructions Activities Tab Contact log(Code, Description) UPDATE: Instructions Additional Info Tab Classification UPDATE: Additional field values added Additional Info Tab References (Type) UPDATE: Instructions Regulatory Reports Tab Aware Date UPDATE: Instructions PMDA tab Immediate Report Flag NEW FIELD for PMDA R3 reporting PMDA tab Study/Research Type NEW FIELD for PMDA R3 reporting PMDA tab Report class UPDATE: Instructions PMDA tab Other reference information UPDATE: Instructions PMDA tab Retrospective Study for infection Field Label change for PMDA R3 reporting PMDA tab Summary of report content Field Label change for PMDA R3 reporting Revision 8.0 dated 15-Nov-2019 Activities Tab User UPDATE: Instructions Activities Tab Other UPDATE: Instructions Activities Tab CheckList New Field Additional Info Tab References UPDATE: Instructions Additional Info Tab References UPDATE: Instructions Event Labeling Guidance N/A UPDATE: Instructions Events Medical Confirmation Updated: Instructions Events Tab Reporter' Seriousness UPDATE: Instructions Events Tab Datasheet UPDATE: Instructions Events Tab [Datasheet] UPDATE: Instructions Events tab Receipt Date UPDATE: Instructions General tab Report type UPDATE: Instructions General tab Classification UPDATE: Instructions General tab Follow Up Information Receipt Date UPDATE: Field name General tab Source Justification UPDATE: Instructions General tab Study Information UPDATE: Instructions General tab State/Province UPDATE: Instructions General tab Literature Information UPDATE: Instructions General tab Reporter Consent Followup New Field for EU GDPR requirements Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 11 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision Patient Tab Patient ID UPDATE: Instructions Patient Tab Ongoing UPDATE: Instructions Products Tab Rechallenge Results UPDATE: Instructions Regulatory Reports Tab Protect Confidentiality of Reporter and Patient UPDATE: Instructions Regulatory Reports Tab Group UPDATE: Instructions Regulatory Reports Tab In 5 Days UPDATE: Instructions Regulatory Reports Tab In 15 Days UPDATE: Instructions Regulatory Reports Tab In 30 Days UPDATE: Instructions Regulatory Reports Tab In UPDATE: Instructions Regulatory Reports Tab Destination UPDATE: Instructions Regulatory Reports Tab Submitted UPDATE: Instructions Regulatory Reports Tab Open UPDATE: Instructions Regulatory Reports Tab Auto Schedule UPDATE: Instructions Regulatory Reports Tab Date Sent UPDATE: Instructions Regulatory Reports Tab Date Created UPDATE: Instructions Regulatory Reports Tab Reason for Non Submission UPDATE: Instructions Regulatory Reports Tab Submission Required UPDATE: Instructions Regulatory Reports Tab Case Revision UPDATE: Instructions Regulatory Reports Tab State UPDATE: Instructions Regulatory Reports Tab OK and Cancel UPDATE: Instructions Revision 9.0 dated 09-Nov-2020 General Tab Report type, Spontaneous UPDATE: Instructions General Tab Classification, Measures report UPDATE: Instructions General Tab Classification, Research Report UPDATE: Instructions General Tab Classification, J Reportable UPDATE: Instructions General Tab Follow-up Justification UPDATE: Additional Comments General Tab Amendment: Data Correction UPDATE: Instructions General Tab Project ID UPDATE: Additional Comments General Tab State/Province UPDATE: Additional Comments General Tab Occupation New Field values added Patient Tab Age Group UPDATE: Instructions Patient Tab Condition type, Historical drug UPDATE: Instructions Patient Tab Gender New Field values added Products Tab Related to Device UPDATE: Instructions and Additional Comments EU/CA Device Pop-up Page: Only populate if product is Products Tab approved as a Device in the EU or Canada UPDATE: Subtitle Products Tab Near incident UPDATE: Additional Comments Products Tab Action Taken UPDATE: Additional Comments Products Tab Abuse New field Products Tab Overdose New field Products Tab Tampering New field Products Tab Device Component Code New field Products Tab Health Effect - Impact Codes New field Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 12 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision Products Tab Third Party Servicer New field Events Tab Details UPDATE: Instructions and Additional Comments Events Tab Datasheet UPDATE: Additional Comments Events Tab Outcome of events UPDATE: Additional Comments Analysis Tab Company Comments UPDATE: Instructions Medical review Company Comments UPDATE: Instructions Activities Tab Contact log, User UPDATE: Instructions Activities Tab Case Unlock, Other UPDATE: Additional Comments Activities Tab Case Unlock, Significant F/U UPDATE: Instructions Activities Tab Case Unlock, Non-significant F/U UPDATE: Additional Comments Additional Info Tab Classification UPDATE: Instructions Additional Info Tab E2b Authority Number UPDATE: Additional Comments Additional Info Tab E2b Company Number UPDATE: Additional Comments Additional Info Tab E2b Report Duplicate UPDATE: Instructions Event Labeling Guidance Event Labeling Guidance UPDATE: Replace GEPIC with CREDO Event Labeling Guidance Event Labeling Guidance UPDATE: EU-SmPC usage Event Labeling Guidance Event Labeling Guidance UPDATE: Medical judgement text Regulatory Reports Tab Submission Required UPDATE: Instructions and Additional Comments Regulatory Reports Tab State, Deleted UPDATE: Additional Comments Regulatory Reports Tab State, New Data Available UPDATE: Instructions Regulatory Reports Tab Local comment UPDATE: Instructions and Field value(s) Regulatory Reports Tab Comment Tab, Local comment UPDATE: Instructions Revision 10.0 dated 02-Mar-2021 Incoming ICSR Reports N/A UPDATE: Title and applicable field names from E2B to ICSR Incoming ICSR Reports Message Type New Field Incoming ICSR Reports Initial / Follow-up / Nullification / Amendment / Downgrade UPDATE: Amedment and Downgrade added. General tab Medically Confirm New Field General tab Amendmets/Follow ups Sub title updated General tab Occupation New Field values added General tab Reporter Look-up, County New Field General tab Reporter Look-up, Postal code New Field General tab Reporter Look-up, Country New Field Patient tab Race Information UPDATE: Field name Patient tab Pregnancy Information, Gestation Period New Field Patient tab Pregnancy Information, Gestation Period unit New Field Patient tab Weeks at Onset Field removed Patient tab Weeks at Exposure Field removed Patient tab Trimester of Exposure Field removed Patient tab Other Relevant History, Ongoing New Field Patient tab Lab data, Assessment New Field values added Patient tab Parent Tab, Gender New Field values added Patient tab Parent Tab, Race Information New Field Product tab Study Drug Not Administered Field removed Product tab Drug Not Administered UPDATE: Field type, Instruction and Additional comments Product tab Substance Information, Substance name New field Product tab Product details, Gestation Period at Exposure and Unit New field Product tab Device Subcomponent Name Field removed Product tab Device Subcomponent Lot# Field removed Product tab Device Sub tab, Device Component Information New field Product tab Device Sub tab, Units New field Product tab Device Sub tab, UDI System New field Product tab Device Sub tab, Unique Identifier (UDI)# New field Product tab Device Sub tab, Reported Malfunction New field Product tab Device Sub tab, Determined Malfunction New field Product tab Device Sub tab, CE Marked New field Product tab Device Sub tab, Incident Information New field Product tab Device Sub tab, Manufacturers Final Investigation Results New field Product tab M/W Info Pop-up Page, Re-Processor Name New field Product tab M/W Info Pop-up Page, Address 1,2 New field Product tab M/W Info Pop-up Page, City New field Product tab M/W Info Pop-up Page, State New field Product tab M/W Info Pop-up Page, Country New field Product tab M/W Info Pop-up Page, Postal Code New field Product tab M/W Info Pop-up Page, Fax New field Product tab M/W Info Pop-up Page, Email Address New field Product tab EU/CA Device Pop-up page, Availability of Device New field Product tab EU/CA Device Pop-up page, Explanation New field Analysis tab MedWatch Information subtab, Consider UF/Importer data Form New sub field Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 13 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision Analysis tab MedWatch Information subtab, User Facility or Importer Name UPDATE: Field name. Added new field values Analysis tab MedWatch Information subtab, Contact Person New Field values Analysis tab MedWatch Information subtab, Phone UPDATE: Field type Analysis tab MedWatch Information subtab, Date aware UPDATE: Field type Analysis tab MedWatch Information subtab, Event Problem Codes Information New field. "Add and Remove" button added Analysis tab Report Sent to FDA UPDATE: Field type Analysis tab Report Sent to MFR UPDATE: Field type Analysis tab Location where event occurred New Field values Analysis tab Other location where event occurred New field Activity tab Contact log, Code New field values Activity tab Custom letter New field values Activity tab Locked or Archived By UPDATE: Field name Regulatory Reports Tab Urgent report New field Medical Review Company Diagnosis/Syndrome Field removed Revision 11.0 dated 30-JUN-2022 Initial Case Entry & Dup Search tab Term Type UPDATE: Drop down options Incoming ICSR Reports tab Message Type UPDATE: Comment added General tab Classification, Reimbursement Program UPDATE: Comment added Patient tab Pregnancy Information,Gestation Period UPDATE: Instruction, Additional comments Patient tab Age group UPDATE: Field value Patient tab Pregnancy Information, Prospective/Retrospective UPDATE: Additional comments Patient tab Parent Sub-Tab, Parent Information, Parent Details New sub-sections added Patient tab Patient Initials UPDATE: Additional comments Patient tab Condition Type UPDATE: Additional comments Product tab Reported Malfunction UPDATE: Additional comments Products tab Determined Malfunction UPDATE: Additional comments Products tab Formulation UPDATE: Additional comments Products tab Study Drug Not Administered UPDATE: Additional comments Products tab Drug Not Administered UPDATE: Additional comments Products tab Study Drug UPDATE: Additional comments Products tab Product Notes UPDATE: Additional comments Products tab Abuse UPDATE: Instruction Products tab Overdose UPDATE: Instruction Products tab Tampering UPDATE: Instruction Products tab Time Between First Dose/Primary Event UPDATE: Instruction Products tab Time Between Last Dose/Primary Event UPDATE: Instruction Products tab PMDA Device Information New sub-tab Products tab PMDA Report Receipt Data New field Products tab Identification No.-Branch No. New field Products tab Registeration No.-Branch No. New field Products tab Malfunction Occurred New field Products tab Scheduled Next Report Date New field Products tab Malfunction Status of Medical Device New field Products tab Health Damage Status for Patient New field Products tab Name of Person in Charge New field Products tab Status of Patient e.t.c when Malfunction Occurred New field Products tab Treatment for the patient New field Products tab First Use New field Products tab Number of Uses New field Products tab Period from the start of use New field Products tab Current status of medical devices New field Products tab Remarks New field Products tab Disposal, Internal Residue, Planned Collection, Uncollectible New field Products tab Investigation Result New field Products tab Correspondence so far New field Products tab Future Correspondence New field Products tab Summary New field Products tab Measure Classification New field Products tab Contents/Summary of Research/ Measure Report New field Products tab PMDA Device Information, Malfunction Status of Medical Device UPDATE: New field, Instruction Products tab Device Sub-tab specific fields, Related to Device UPDATE: Instruction Events tab Receipt Date UPDATE: Additional comments Events tab Medically Significant UPDATE: Additional comments Events tab Patient Has Prior History? UPDATE: Instruction Events tab Infection UPDATE: Instruction Events tab Date of Death UPDATE: Instruction Events tab Term Type UPDATE: Field value dropdown Events tab Event Assessment, Excluding to PMDA Reports UPDATE: New field Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 14 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision Events tab Recalculate UPDATE: Additional comments Events tab As Determined Listedness UPDATE: Instruction Analysis tab Narrative UPDATE: Instruction Analysis tab Reporter's comment UPDATE: Instruction Analysis tab Japan Initial Receipt Date UPDATE: Instuction, Additional comment Analysis tab Japan Follow-up Receipt Date UPDATE: Instuction, Additional comment Activities tab QC Attachments UPDATE: Instruction Additional Info tab Reference type, partner/non-partner UPDATE: Additional comments Additional Info tab Reference type, JAD REF# UPDATE: Instruction Additional Info tab Reference type, E2B GP Medical No. UPDATE: Instruction Additional Info tab Reference type, Hospital Record Number UPDATE: Instruction Additional Info tab Reference type, Specialist Number UPDATE: Instruction Additional Info tab Classification UPDATE: Instruction Medical Review tab Case Serious UPDATE: Field value Regulatory Reports Tab State, Approved UPDATE: Instruction Regulatory Reports Tab Protect Confidentiality of Reporter and Patient UPDATE: Instruction Regulatory Reports Tab Comment Tab, Local comment UPDATE: Instruction Revision 12.0 dated General tab General information: Country UPDATE: Additional comments General tab Classification, Ichihen Removed: Case classification General tab Classification New Field values, Instructions General tab Classification, Invalid case UPDATE: Instruction General tab Amendment, Amendment Justification J (J user only) New Field values, Instructions, additional comments General tab Amedments/Follow-ups, PV Receipt Date UPDATE: Additional comments General tab Amedments/Follow-ups, Amendment data correction UPDATE: Instruction, Removed additional comments General tab Amedments/Follow-ups New Field values, Instructions General tab Amedments/Follow-ups, Significant UPDATE: Instruction General tab Amedments/Follow-ups, Follow-up Justification, Data Correction UPDATE: Additional comments General tab Report Sent to Regulatory Authority by Reporter UPDATE: Instruction General tab Reporter information, Institution ID UPDATE: Instruction General tab Reporter information, State/Province UPDATE: Additional comments General tab Literature information: Country of publication, Study/Research TypeNew Field, Instructions, additional comments Patient tab Concomitant Therapy Administered UPDATE: Field name, type, value, instructions Patient tab Pregnancy information, Prospective / Retrospective UPDATE: Additional comments Patient tab Lab data, Notes UPDATE: Instruction, Additional comments Patient tab Patient details, age UPDATE: Instruction Patient tab Patient details, age units UPDATE: Additional comments Patient tab Other relavant history, historical condition UPDATE: Instruction Patient tab Relavant test UPDATE: Instruction, Removed additional comments Product tab Formulation UPDATE: Additional comments Product tab Action taken UPDATE: Additional comments Product tab Product information, Product name UPDATE: Instructions, Additional comments Product tab Drug not administered UPDATE: Instructions, Additional comments Product tab Product information, Product identifier New Field Product tab Product details, Dechallenge Results UPDATE: Additional comments Product tab Product details, Rechallenge Results UPDATE: Additional comments Product tab Product information, Product notes UPDATE: Removed and added statement in additional comments Product tab PMDA Device Information, Future Correspodence UPDATE: Instruction Product tab PMDA Device Information, Summary UPDATE: Instruction Product tab Dosage regimen, Batch/Lot# UPDATE: Additional comments Product tab EU/CA Device Pop-up Page UPDATE: Header statement Event tab Patient Has Prior History? UPDATE: Instructions Event tab Outcome of events UPDATE: Additional comments Event tab Event Assessment Sub-Tab, Excluding to PMDA reports UPDATE: Instructions Event tab Seriousness criteria, Hospitalized UPDATE: Additional comments Event tab Seriousness criteria, Medically significant UPDATE: Additional comments Event tab As Reported Causality UPDATE: Additional comments Event tab As Determined Causality UPDATE: Additional comments Event tab As Determined Listedness UPDATE: Instructions, Additional comments Event tab Term Highlighted by Reporter UPDATE: Removed field value and Instructions 'Unknown' Event tab Medical Confirmation UPDATE: Removed additional comment Event tab Identification of Country where event occurred UPDATE: Field name updated to Country in which Event Occurred Analysis tab PMDA Info sub-tab, Japan Initial Receipt Date UPDATE: Instructions Analysis tab PMDA Info sub-tab, Japan Follow Up Receipt Date UPDATE: Instructions Analysis tab Narrative UPDATE: Additional comments Analysis tab Study/Research Type UPDATE: Removed Study/Research Type Analysis tab PMDA Info sub-tab, Immediate report flag UPDATE: Field type, value, Instructions Analysis tab PMDA Info sub-tab, Reason for downgrade UPDATE: Field name, Instructions, E2B Mapping Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 15 of 154  Argus DEC V12.0 Guide Summary of Revisions Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Tab Field Name Revision Analysis tab PMDA Info sub-tab, Downgrade report flag New field Analysis tab PMDA Info sub-tab, Comments for start date of reporting timeframeUPDATE: Field name, Instructions, E2B Mapping, additional comments Analysis tab PMDA Info sub-tab,Start date of reporting timeframe New field Analysis tab Evaluation in light of similar events in the past UPDATE: Instructions Analysis tab PMDA Info sub-tab, Remarks 1 and 2 Removed: field values Activities tab Action Items, Code, Case Deletion UPDATE: Instructions Activities tab Contact Log, Code, Amendment Removed: field value, additional comment Activities tab Contact Log, Code, Description UPDATE: Additional comments Additional tab Notes and Attachments, Incl. Reg. Sub UPDATE: Instructions Additional tab Notes and Attachments, Classification New fields Regulatory Reports Tab Comment Tab, Local Comment UPDATE: Instructions Medical Review tab Narrative UPDATE: Instructions Medical Review tab As Reported Causality UPDATE: Additional comments Medical Review tab As Determined Causality UPDATE: Additional comments Event Labeling Guidance Event Labeling Guidance UPDATE: IB text Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 16 of 154  Argus DEC V12.0 Guide Initial Case Entry & Dup Search Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Initial Case Entry & Duplicate Search X Field Name Field Type Field Values Instructions Additional Comments Case Search Criteria (Case Action Tab - New) You can search for a potential duplicate case using any combination of fields in the General section. However, you need to collect the fields carefully to ensure that a duplicate is not missed. It is recommended to start the search with fewer fields and add additional fields to the search criteria gradually to reduce the number of cases found. Initial Receipt Date Select Radio N/A Default value - do not change Button Receipt Range Limits Select Radio N/A DO NOT USE [Three Month Date Button Range] Case Search Criteria: Action Buttons Search Button N/A Click to perform duplicate search. Total Number of Rows section is displayed listing cases found matching the search criteria. Continue Button N/A Click to continue the bookin of an initial BookIn section will be displayed to enter Seriousness and case. Causality. Clear Button N/A Click to clear all entered information on the Bookin screen as required. Full Search Checkbox N/A DO NOT USE (Like,soundex) General Initial Receipt Date Date N/A -Enter the date that any representative of Date does not change with follow-ups. For cases that are Otsuka becomes aware of new safety in question of being valid, route case to Follow Up information. Pending. Once information is provided that confirms the -This is the global regulatory clock start case is valid, the initial receipt date should be updated to date. the date it was confirmed to be a valid case. -See Otsuka GxP PV Glossary for additional details. -User may enter '=' and then Tab key to auto- populate current date. PV Receipt Date Date N/A - Enter the date Otsuka PV receives new Partial date cannot be used. safety information. - Enter a full date in ddmmmyyyy format. - This is the date when Otsuka Global PV first becomes aware of safety information including adverse events, pregnancy and adverse events associated with product complaints. Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 17 of 154  Argus DEC V12.0 Guide Initial Case Entry & Dup Search Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Field Name Field Type Field Values Instructions Additional Comments Country Look-up A list of countries - Select country where the adverse event If country is not known, use the reporter's country. occurred. - Type the first letter of the country to For Literature cases, if the country of incident is unknown expand the Country code list. use the country of the Primary Author. - Alternatively, type country code and then click Tab key. FOR JAPAN FOREIGN SAFETY MEASURES REPORT - Enter country where the measure was published. However, if the same measure was taken in multiple countries, do not change the COI, enter the additional country(ies) concerned and the publication status as follow- up information in J.10. The original value for COI should remain unchanged. FOR JAPAN RESEARCH REPORT - Enter COI (where the organization the reporter/author belonged to or the trial site was located). Report Type Drop-down Spontaneous Literature Select for literature-containing safety - For CT report type: Study selection is available. Click information not described in the context of a Select button to select a study. When a study is selected, clinical trial. all relevant information will be auto-populated. Type the first letter of the report type to filter the code list and select the appropriate - For PM report type: Enter Product information Report Type and then click the Tab key. You can also double-click on the field to expend the code list and select the FOR JAPAN FOREIGN SAFETY MEASURES REPORT appropriate Report Type. OR RESERCH REPORT- Select "Spontaneous Literature" or "Clinical Literature". Clinical Literature Select for literature-containing safety information from clinical trials. Not Available to Sender DO NOT USE - only applicable for import of E2b cases. Change this to another type upon Triage. Spontaneous Select for safety information received regarding the unsolicited use of a commercial product EXCLUDING Literature cases. Clinical Trial Select for safety information received from any solicited source. Version 12.0 Otsuka Pharmaceutical Co., Ltd., Confidential Page 18 of 154  Argus DEC V12.0 Guide Initial Case Entry & Dup Search Doc.No. GSD-GLB-COMP-2022-0045-00027.001 Approved On 19-Oct-2023 12:29:21 AM (EDT) Field Name Field Type Field Values Instructions Additional Comments Select Button N/A Click this button to select configured This button will only be available if Clinical Trial or Clinical protocols which are used in support of Literature is chosen as a report type. known clinical trials and solicited programs. Project ID Auto-fill N/A Auto-populated when a configured protocol Only available if Clinical Trial or Clinical Literature is is selected. chosen as a report type. Please note, for non-configured studies, notify the work flow manager's team to have the study configured. Study ID Auto-fill N/A Auto-populated when a configured Only available if Clinical Trial or Clinical Literature is protocol is selected. chosen as a report type. Center ID Free-text N/A Enter if available, otherwise leave blank. Only available if Clinical Trial or Clinical Literature is chosen as a report type. Initial Justification Justification CC-DI Center Select when received from DI Center