Training on SOP on Argus safety database

1. Training on SOP on Argus safety database Global Pharmacovigilance department

2. OBJECTIVE • To lay down a procedure for handling the Argus safety database

3. SCOPE • This SOP applies to handling Argus safety database

4. RESPONSIBILITY • Personnel responsible for handling Argus safety database are responsible to follow this SOP.

5. PROCEDURE • Argus Safety is a comprehensive adverse event tracking and reporting system used by Aurobindo Pharma limited to collect, record, access, distribute and store data of adverse events associated with Aurobindo’s products. The data stored within Argus Safety is used both for the generation of the regulatory/management reports and for the analysis of possible safety signals. The source documents like communications form the health care professionals and consumers are also documented in Argus Safety. • Argus database is installed at Aurobindo with its server located at Hyderabad, India. It is a web based application accessible to individual responsible person(s) at India/affiliates.

6. PROCEDURE The system has been subjected to qualification testing to ensure that it will satisfactorily perform the required performance/business functions and behave correctly, consistently, and reliably in its operating environment thus meeting the performance/business needs of the users. The Argus Database system has been configured: • To enter products, licenses. • To enter ADR data including follow up information, perform a quality review and medical review. • To perform reporting and distribution and submission of the cases to the regulatory authorities. • To classify cases as Serious or Non serious, Listed or Unlisted. • To route cases to other Regions via workflow or by distribution server (i.e. emails/E2B) to ensure regulatory reporting obligations are met.

7. PROCEDURE • Access to database: Access to the screens, fields and reports is governed by the role assigned to a given individual. Therefore while all fields are described in different Standard operating procedures, the ability to enter and edit data and generate and print reports will not be available to every user.

8. Procedure • Procedures: Well defined procedures shall be in place for performing various activities in the Argus Safety Database. • Training on Argus safety database: Personnel should be familiar with the regulatory and medical responsibilities of the safety surveillance. Personnel are only permitted access once they are trained in the use of the system, and in any other relevant local SOPs and have been accredited as proficient to undertake those tasks that have been designated as their responsibility. • Workflow: It is a well defined standardized sequence of process steps to support case processing and report generation from initial case receipt to case closure after being processed. It allows tracking of cases between users and states of activity.

9. Procedure • Overview of the workflow: The transition of cases through Argus Safety follows a sequence of workflow states. Each workflow state consists of workflow rules which the system checks after each workflow state’s activities are completed. Each case entered in Argus Safety will follow the workflow states from initial case receipt to case closure. The workflow states are displayed in a worklist. The worklist displays each user’s workload at any given time period. The worklist displays cases by priority. This priority is defined by the workflow rules, such as seriousness, relatedness and reportability time frames. Each workflow state is assigned to a workflow group, which are usually people assigned to the same job function. A workflow manager has authority to oversee a specific workgroup’s cases. Different workflow states are:

10. Workflow stages • Book in:Enter preliminary case data, perform duplicate search, book-in the case which assigns case identifier. • Case entry: Complete the data entry for cases and forward to Medical Review. • Medical review: Review case including case description and seriousness criteria, check coding of adverse events in MedDRA, labelling assessment, send back to data entry for modifications or send to Quality review for review. • Quality review: Review case for accuracy and labelling, forward all cases to Submission for submitting to the authorities, send back to data entry/medical review for modifications. • Global Submission: Submits the cases to the regulatory authorities, affiliates or the business partners. Forward the case once submitted to the authorities to case archival. If no submission to the authorities is required, forward the case to case archival. • Case Archival: Cases archived.

11. Simplified Argus Workflow Case Archival Initial receipt of cases/Book in Report cases to regulatory authorities Case entry QC Medical review

12. Procedure • Workflow group:The Workflow group is defined as a number of persons usually assigned to the same job / role. For example: Book-in group. • Workflow rule: Sequence of logical expressions combining several case criteria which instruct the system to route a case to the appropriate workflow state. For example: Rules check values of defined criteria such as case type, seriousness, relatedness, reportability requirements (e.g., time frames) • Workflow manager:The Workflow manager has overview of where cases are in the process for all Aurobindo groups. Workflow managers can re-assign cases to other people in case of absences. Workflow managers can change case priority. Workflow managers can reroute cases to other workflow states.