Pharmacovigilance process at Bioforum –

1. Study Setup I 
   • Safety Management Plan (SMP)
     Safety Management Plan (SMP) is prepared to fully detail the processes and procedures required as part of handling the Adverse Drug Reactions (ADRs) as part of the study conduct. All procedures and responsibilities are outlined and the plan is approved by the customer.
   • Database Setup
     Study is set up using PV-Works® in order to have all study cases processed, and all study information is configured in the database.
2. Study Setup II – EudraVigilance Registration
   • If the study is planned to run within the European Union, we compile the documentation and register the trial Sponsor and EV Responsible Person in EudraVigilance.
3. Case Reporting
   • The Investigator reports any Serious Adverse Event (SAE), whether it is considered to be related to study medication or not, by completing a Serious Adverse Event Form and sending it to the designated address (Within 24 hours).
4. SUSAR Assessment
   • The SAE is then assessed by Bioforum PV personnel, determining whether the Adverse Event is serious and unexpected, which will qualify the event as a SUSAR and if so, whether a 7-day or a 15-day is required.
5. Case Entry
   • The SAE is then entered into PV-Works® and 100% QC check is performed on the data entered. Often there is essential missing information for the case entry process, in which Bioforum can directly communicate with the site to quickly obtain the missing information.
6. Medical Assessment
   • The designated Bioforum PV physician then codes the verbatim event term, medical history and other relevant information using MedDRA (the latest version of MedDRA), and perform case level assessment, write the clinical narrative for the case and communicate with the site at any data queries. All corresponded information is then appended to the case within PV-Works.
7. SUSAR 7-days/15 days Reporting
   • A draft MedWatch 3500A or a CIOMS report is then produced and circled among the stakeholders. Changes are made to the case based on feedback still as a draft report. For cases that are not considered to be a SUSAR, this report will be used for information purposes only. For cases that are considered SUSARs, a submission-ready copy is then produced according to the agreed-upon timelines.
   • A 7-days or 15-days expedited report should be received by the ECs/IRBs (Ethical Committees/Institutional Review Boards) and RAs (Regulatory Agencies) no later than 7 or 15 calendar days, respectively after the sponsor or its representatives become aware of the event.
8. Case Follow-up
   • Responses from the sites to any pharmacovigilance queries are added to the database following the process described above. All updates/changes are done using audit trail and do not compromise the original information that was entered.
   • If required, Bioforum discuss the case with the sponsor to decide whether as a result of the event, any action is necessary to protect patient safety and if so initiate such actions.

9. Periodic Reporting
   • All SAEs that are reported are included in line listings, produced from the PV-Works database at time intervals requested by the customer. These listings are also incorporated into the Development Safety Update Report (DSUR) using the requirements and structure defined in the ICH guideline E2F.