1. MedDRA 9.0 PSI Proprietary MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program Mark Vieder, R.Ph. PSI International, Inc DIA Annual Meeting June 20, 2006, Philadelphia

2. MedDRA 9.0 PSI Proprietary Mentor-Protégé Approach to Training NONE OF US ARE AS SMART AS ALL OF US. Japanese proverb

3. MedDRA 9.0 PSI Proprietary Why MedDRA Training ? Only MedDRA-trained professionals/team can perform: –Coding with accuracy and specificity –Coding with consistency and uniformity –Data summarization by Primary/secondary SOCs –Comprehensive retrieval by medical topics (SMQs) –Signal detection –Case series definition ….

4. MedDRA 9.0 PSI Proprietary MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program Initial exposure Mentor-protégé phase Coding team Documentation Summary

5. MedDRA 9.0 PSI Proprietary MedDRA Training: Initial exposure Objectives: –Outline the data input/output path –Discuss MedDRA content, structure and challenges –Discuss criteria for an acceptable verbatim –Introduce the concept of “Coding Guidelines” –Provide a coding and retrieval overview

6. MedDRA 9.0 PSI Proprietary MedDRA Training: Initial exposure Delivery Method: –Computer based training (CBT) –Formal class presentation Generic content Customized content according to audience (investigators, statisticians…)

7. MedDRA 9.0 PSI Proprietary MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program Initial exposure Mentor-protégé phase Coding team Documentation Summary

8. MedDRA 9.0 PSI Proprietary MedDRA Training: Mentor-Protégé Phase Mentor: -“trusted counselor or teacher who gives another person help and advice over a period of time and teaches them how to do their job” Senior coder and trainer (internal or external) Clinical experience Knowledge of SOPs, coding guidelines, workflow, management structure Protégé: -“a person who receives support and protection from an influential patron who furthers the protégé's career” Motivated health care professional

9. MedDRA 9.0 PSI Proprietary MedDRA Training: Mentor-Protégé Phase Objective of this phase: have the protégé be proficient in: Verbatim evaluation/extraction Adherence to Coding Guidelines MedDRA Coding with medical accuracy, specificity and consistency Achieved by: Formal Hands-on coding class Internal Coding tool access and use Verbatim and narrative coding exercises Certification program Development of protégé’s proficiency Application and demonstration of skills Metrics for evaluation

10. MedDRA 9.0 PSI Proprietary Mentor-protégé phase: Hands-on Coding Class MedDRA content ICH-endorsed MedDRA Coding guidelines MedDRA Coding techniques Top down approach Bottom up approach Examples using organization specific data and coding guidelines Clinical safety perspective (verbatim string) Drug safety (pharmacovigilance) reports Synonym table maintenance

11. MedDRA 9.0 PSI Proprietary Hands-on Coding class MedDRA content Scope What is included What is excluded Granularity Structure Hierarchy Multiaxiality Primary SOC Secondary SOC assignment Retrieval groupings (SMQs) Rules and conventions

12. MedDRA 9.0 PSI Proprietary Hands-on Coding class Diagnosis with signs/symptoms‘Gastroenteritis with severe diarrhea’ Provisional diagnosis with signs/symptoms‘Diarrhea probably due to gastroenteritis’ ‘Diarrhea due to gastroenteritis or to the medication’ Combination terms: criteria for splitting‘Neck pain due to MVA’ ‘Nausea and vomiting’ Coding of investigational results‘Potassium 7.1’ Infection site vs. microorganism‘Lung infection pseudomonal’ Modification of a pre-existing condition‘Aggravated lung infection pseudomonal’ MedDRA Coding guidelines ICH-endorsed MedDRA Term Selection: Points to Consider Organization specific Coding Guidelines: Clinical/Pharmacovigilance

13. MedDRA 9.0 PSI Proprietary Hands-on Coding class “cancer related fever” Top down approach 1. Search Neoplasm SOC for appropriate section on cancer-related complications, drill down from HLGT to HLT to closest PT and finally LLT MedDRA Coding techniques “wakes up too early” Top down approach 1. Search appropriate SOC for section on sleep disorders, drill down from HLGT to HLT to closest PT and finally LLT “wakes up too early” Bottom up approach 2. Search on text string %wake%; examine all resulting LLT-PTs

14. MedDRA 9.0 PSI Proprietary Hands-on Coding class ‘Patient was admitted to ER after having taken Drug X. Diagnosed with tubular nephropathy as a result of drug toxicity.’ LLT Nephropathy toxic OR LLT Nephropathy tubular LLT Drug toxicity Explanation of a “thought process” used in finding the most appropriate LLT in MedDRA “adenomatous colonic polyp” 1.Search for the entire verbatim 2.Define main medical concept 3.Repeat search “red, itchy rash” 1.Search for the entire verbatim 2.Define main medical concept 3.Repeat search

15. MedDRA 9.0 PSI Proprietary Mentor-protégé phase: Electronic Certification Certification Program: –Fine-tuning of coding skills Exercise program with increasing level of complexity Application of clinical skills, verbatim assessment and coding ability –Communication between Mentor and Protégé Protégé submits a processed record Mentor feedback: validation as correct or constructive observation Protégé attempts until he/she ‘gets it right’

16. MedDRA 9.0 PSI Proprietary Verbatim extraction Capturing all medically significant information of the event Application of Coding guidelines Application of MedDRA granularity Stand-alone criteria for a verbatim

17. MedDRA 9.0 PSI Proprietary Fine-tuning of coding skills Coding of ‘similar’ verbatims: ‘Open wound on left foot’ ‘ Wound on foot’ ‘Infected wound on foot’ OR ‘Foot puncture wound’ ‘Stepped on a nail’ ‘Foot injury due to a nail’

18. MedDRA 9.0 PSI Proprietary Fine-tuning of coding skills (2) Medically correct coding: “vaginal bleeding” in a pregnant patient in a postmenopausal patient following a cervical biopsy

19. MedDRA 9.0 PSI Proprietary Fine-tuning of coding skills (3) Specific Coding guidelines: “Bacterial pneumonia Aug. 2000” “Insomnia due to cystitis” “Increased liver enzymes, jaundice, hospitalized to R/O Hepatitis”

20. MedDRA 9.0 PSI Proprietary Electronic Certification Protégé coding ‘

21. MedDRA 9.0 PSI Proprietary Electronic Certification Mentor feedback ‘

22. MedDRA 9.0 PSI Proprietary Electronic Certification Protégé coding correction ‘

23. MedDRA 9.0 PSI Proprietary Electronic Certification Mentor feedback: record completed ‘

24. MedDRA 9.0 PSI Proprietary Electronic Certification Metrics After successful Electronic Certification program completion, Protégé graduates to the Coding team

25. MedDRA 9.0 PSI Proprietary MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program Initial exposure Mentor-protégé phase Coding team Documentation Summary

26. MedDRA 9.0 PSI Proprietary Coding team Workflow: –Coding –Coding Quality Control Overview of the entire team’s output Real-time “mentoring” of coders by the QC team –Coding Quality Assurance: sample review –Synonym table maintenance Approval process for Verbatim-LLT additions Periodic Synonym table review Training material

27. MedDRA 9.0 PSI Proprietary Coding team (2) Coding skills maintenance program: MedDRA version changes training Coding guidelines changes training Focus on identified areas of concern (emails, notices, white-board, meetings) Continued coder education Internal presentations, trainings Professional organizations: DIA and related training courses, workshops, conferences

28. MedDRA 9.0 PSI Proprietary MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program Initial exposure Mentor-protégé phase Coding team Documentation Summary

29. MedDRA 9.0 PSI Proprietary MedDRA Training: Documentation Documentation of training (compliance) –Training SOP (Mentoring phase and beyond) –Training checklist –Employee Training record and certificates –Continued education record Documentation of MedDRA processing issues –Material for training examples –Focus of output review

30. MedDRA 9.0 PSI Proprietary Summary Good training program: – Experience based learning process – Individual support through a Mentor/Group – Documentation Benefits: – Reliable, dependable data input/output – Regulatory compliance Risks: – Only if the training is lacking…