Entering data in General tab in Argus safety database

1. Entering data in General tab in Argus safety database Global Pharmacovigilance department

2. General Tab • Entry in the fields for report type, Country, Initial receipt date, Central receipt date, Initial justification, reporter type are done at book in stage. Check the data entered.

3. Fields with data entry errors or inconsistencies will be indicated with an orange or red sphere. A red sphere denotes a serious error, which has to be corrected prior to saving the case. An orange sphere denotes a warning. The error or warning message is displayed by clicking on the sphere. Validation error messages will also appear for serious errors if the user attempts to save the case. All validation errors or warnings can be viewed together by accessing any sphere which appears at the top right hand corner of each tab.

4. Classification Click to add classification to a case Click to delete classification Select from the codelist

5. Classification options

6. Medically confirm Note: To be populated only for the cases initially received from a non health professional. For initial reports received from a non health professional, select “No” from the codelist. If on follow up, confirmation is received from a health care professional, select “Yes” from the codelist. If the health care professional disagrees with the consumer, Medically Confirmed should be left as “No”. Opinion of both the parties should be included in the narrative. If the health care professional partially confirms the case, select “Yes” from the codelist. Opinion of both the parties should be included in the narrative. When a non- health care professionalsubmits medical documentation along with their initial reports data element Medically Confirmed should be “Yes”. If the initial reporter is ahealth care professional, data element Medically confirmed should be left blank.

7. Reporter information

8. Who is a reporter? It is the person providing the case-related information.

9. Reporter information Screen If report was sent to the regulatory authority by the reporter Occupation of the reporter Select “Yes” if reporter is HCP Name of the reporter Check for all cases except literature Address of the reporter Country of the reporter Reporter to whom Aurobindo will contact for more information Means by which the report reached Aurobindo Type of reporter Reporter who made the actual report to Aurobindo Do not enter data Make sure that the postal code is entered for cases from Spain. Make sure that the country of the reporter has been entered

10. Reporter information The Select button allows you to search for the reporter’s address if it is already available in the system.

11. Reporter look up screen

12. Reporter look up screen • Before clicking on Search, you have to check the Search Cases radio button. • If the reporter's name and/or address are already in Argus, highlight and Select the appropriate row in the Reporter lookup dialog box. Otherwise, cancel this dialog and type the details manually. • Please ensure that the postal code is entered for cases from Spain as postcode is an E2b requirement for these reports.

13. Remember • When an AE is initially reported by a consumer, the consumer is entered as the primary reporter. In the event that the consumer report is then later confirmed by a Health Care Professional, the Health Care Professional becomes the Primary Reporter and Correspondence Contact. • If the opposite occurs i.e. additional information is provided by the consumer after an initial report has been submitted by a Health Care Professional, Health Care Professional remains the primary reporter and the correspondence contact.

14. Health Care Professional • Select “Yes” if the reporter is the health care professional and “No” if the reporter is the not a health care professional. • Do not select Unknown.

15. Reporter Type: Select the reporter type from the codelist. • Reporter type should always be populated • Occupation: Occupation of the reporter. Select from the codelist as per the source document. If the reporter is non- health professional, select “NA” from the codelist.

16. Report sent to Regulatory Authority by Reporter? • Select “Yes” from the code list if it is known that the reporter had submitted the report to the Regulatory Authority. Select “No” if it is known that the reporter had not submitted the report to the Regulatory Authority. Select “Unknown” if it is not known that the reporter had submitted the report to the Regulatory Authority.

17. Protect confidentiality • If this check box is selected, the name and address of the reporter does not appear on regulatory reports and the reporter's information displays “PRIVACY”. DO NOT CHECK THIS BOX FOR LITERATURE CASE REPORTS.

18. Correspondence contact • Checking this check box determines whom Aurobindo will contact for follow-up information on a case report. More than one reporter can be selected as correspondence contacts.

19. Primary Reporter • The checkbox should be used to specify the individual who made the actual report to Aurobindo. This could be the patient, his or her physician, pharmacist, etc. This individual's name will print on regulatory forms unless the Protect Confidentiality checkbox is ticked. The selection of the Primary reporter is mandatory. Only one primary reporter is permitted per case. On a case with multiple reporters, deletion of the Primary reporter will automatically change the Secondary reporter to Primary. • Note: A single reporter can be designated as both the Primary Reporter and Correspondence Contact.

20. Primary reporter for literature cases • The reporter information tab should be populated for each author separately. Primary reporter should be checked only for the First author for the literature article. Correspondence contact should be checked for the author who is mentioned as the contact in the literature article. Literature information field shall be completed as per the section on Literature Information. Do not check the box for Protect confidentiality.

21. Report Media • It is the means by which the report is communicated to Aurobindo. This is an internal administrative categorization, which will be useful in evaluating the flow of information in Aurobindo. The media codes available in Argus Safety are: Fax, Letter, Phone, Website, Email, Internet.

22. Intermediary • It provides the ability to trace reports through the reporting process, from originating source through other internal or external channels before reaching Aurobindo. The intermediary codes available in Argus Safety are: Licensee, Other, Regulatory Authority, Sales rep, Local affiliate.

23. Deleting Reporter Right click on the any space in the reporter details fields and select delete.

24. Copying reporter Right click on the any space in the reporter details fields and select Copy.

25. Re-arranging reporter Right click on the any space in the reporter details fields and select Re-arrange.

26. Re-arranging reporters You can rearrange the reporters by clicking “Up” or “Down” button as required

27. Literature information screen: This field is enabled when the report type is either literature or study Mention all the authors Year of publication of journal Volume of journal Title of the literature article Journal title Page numbers Click to create additional literature information tabs if more than one literature reference available

28. Study Information screen: Visit when the adverse event happened Phase of the study Short name of the study Status of the blinding Full title of the study Type of blinding Type of observe study Week into study when the adverse event occurred

29. Entering clinical trial information If the report type is selected as clinical study, the field for study information is enabled.

30. Study information Project ID, Study ID, Centre ID is entered at the time of book in. Cross check for correctness. Enter Project ID as “UNKNOWN” if not known. Select from codelist Entering the study ID enables the field of study description. If Study ID is not known, enter “UNKNOWN”. If the blinding status is changed to not blinded, current date is auto populated. Enter study description (if enabled) (for Non Aurobindo clinical trial cases)

31. Observe study type • Follow the below mentioned table for selecting the “Observe Study Type” in Argus safety database:

32. Study type Options are: Single Blinded, Double Blinded, Not blinded

33. Unblinding A case can be unblinded by selecting the option “Not blinded” in the Study type. The following screen is displayed Enter the password and Click OK. The field ‘Unblinding Date’ will be automatically populated.

34. End of study blinding After a blinded clinical study has ended, the study can be unblindedby selecting “End of study” option available in the “Utilities”.

35. The following screen opens: Select the Study ID to be unblinded from the codelist. Selecting the study will lists cases for the selected study. If required, the cases where blind has not been broken can be searched for the selected study by checking the box for “Display only unbroken cases”.

37. Select the drug received by the patient in the respective case from the codelist

38. Drug dosage The drug dosage used by the patient can be entered by using the “Select” button. The following screen will open: Enter the drug information.

39. Study name is the short name for the study. • Week# and visit#: week no. and visit no. of the patient when he experienced the adverse event.

40. Handling different reporter types

41. Reports Received from Health Authorities and Other Intermediary Reporters • Enter the primary reporter’s name, if known. • If the primary reporter name is unknown, leave the reporter’s First Name and last name field empty • Select Yes from the drop down list Health Care Professional if the reporter is a health care professional as mentioned in the source document. • Check the Primary Reporter box. • For Intermediary, select from the drop down list e.g. ‘MHRA’. • Select 'Yes' from the drop-down list in the “Report Sent to Regulatory Authority by Reporter?” field if appropriate. Leave empty if not reported. • Check “Protect Confidentiality” if required.

42. The details of the health authority report number shall be entered in the references section of additional information section tab of Argus safety. Enter the name of the Authority in the “Reference notes” field. Example: MHRA

43. License partner cases • Enter the initial reporter as a primary reporter. • If the reporter is a health care professional, please select 'Yes' in the Health Care Professional field. Select “No” if it has specifically been stated that the reporter is as not a HCP, enter as appropriate e.g. Consumer, lawyer or relative. Select “license partner” from the codelist of intermediary.

44. Non License partner case (Cases received from another pharmaceutical companies which are not our business partners) • Enter the initial reporter as a primary reporter. • If the reporter is a health care professional, please select 'Yes' in the Health Care Professional field. Select “No” if it has specifically been stated that the reporter is as not a HCP, enter as appropriate e.g. Consumer, lawyer or relative. Select “Other” from the codelist of intermediary

45. Consumer Reports • Initial Consumer Report: When an AE is initially reported by a consumer, the consumer is entered as the primary reporter. In the event that the consumer report is then later confirmed by a Health Care Professional, the Health Care Professional becomes the Primary Reporter and Correspondence Contact. • If the opposite occurs i.e. additional information is provided by the consumer after an initial report has been submitted by a Health Care Professional, Health Care Professional remains the primary reporter and the correspondence contact • Enter the reporter’s name and details in the reporter information fields, if appropriate and Check the Protect Confidentiality box • Select the appropriate response from the drop-down list for Health Care Professional (‘Yes’ or ‘No’). • If the reporter type is non heath care professional select Unknown for the occupation of the reporter. • As Reporter Type, also select ‘Consumer’ from the drop down list. Check Primary Reporter and Correspondence Contact boxes. • Select ‘Unk’ from the drop-down list in the Report Sent to Regulatory Authority by Reporter? field, unless specified on the report.

46. Consumer is Health Care Professional • Enter like a consumer report with reporter details (name address etc) • Select ‘Yes’ for Health Care Professional. • Reporter Type is ‘Consumer’ • Check ‘Protect Confidentiality’ box.

47. Consumer provides medical records including a consultation report from the prescribing physician or other physicians • Enter the physician as the Primary Reporter. • Select ‘Yes’ for the Health Care Professional and select ‘Physician’ as Reporter Type and Occupation • Enter the consumer as second reporter.

48. Legal Cases Reported to Aurobindo by a Legal Professional • In theory it is possible for a legal professional to inform the company of an SAE without any medical documentation to support the claim. In this case, the legal professional would be entered in the same way as a consumer in that the case would be classified as a non HCP case. The reporter type and occupation would be selected to reflect the fact that the reporter was a legal professional (lawyer).