Taking GCP Training to a New Level:

1. Taking GCP Training to a New Level: Making a Bottom Line Impact Ruth Ann Nylen, PhD The RAN Institute Paul Mastoridis, Pharm D Schering-Plough Corporation

2. Ruth Ann Nylen, PhD The RAN Institute Tampa, FL

3. Discussion Topics • Discuss requirements for GCP training for investigators and sponsor personnel • Discuss reasons for the performance gap between training and resulting documentation • Describe solutions that can be implemented to close the performance gap • Discuss tools/techniques used in GCP Training

4. GCP training requirements for investigators Studies conducted under an IND: • US FDA Regulations • ICH GCP Guideline • Other relevant ICH guidelines • Other relevant FDA guidelines • Form FDA 1572 requirements

5. Regulatory References • www.ich.org • www.fda.gov • www.regsource.com • www.nih.gov

6. GCP training requirements for investigators • The protocol • Study-specific requirements • Sponsor expectations Exceptions for Non-IND studies

7. GCP training requirements for sponsor personnel • Clinical Research Personnel • All regulations and guidelines for sponsors and investigators • Statistics and Data Management Personnel • Study design • Data management, collection and analysis

8. GCP training curriculum content for sponsor personnel FDA Regulations • 21 CFR 11 Electronic Records; Electronic Signatures • 21 CFR 50 Protection of Human Subjects • 21 CFR 54 Financial Disclosure • 21 CFR 56 Institutional Review Boards

9. GCP training curriculum content for sponsor personnel FDA Regulations • 21 CFR 312 Investigational New Drugs • 21 CFR 314 New Drug Applications • 21 CFR 812 Investigational Device Exemptions • 21 CFR 814 Pre-market approval applications

10. GCP training curriculum content for sponsor personnel FDA Guidelines • FDA Guideline for the Monitoring of Clinical Investigations • FDA Information Sheets for IRBs and Clinical Investigators • FDA guidelines for product development

11. GCP training curriculum content for sponsor personnel ICH Guidelines: Efficacy “E” Guidelines • E 1 Population exposure • E 2 Clinical safety • E 3 Clinical study reports • E 4 Dose response • E 5 Ethnic factors • E 6 GCP

12. GCP training curriculum content for sponsor personnel ICH Guidelines • E 7 Special populations • E 8 General considerations for trial design • E 9 Statistical principles • E 10 Choice of control group • E 11 Pediatrics • E 12 Antihypertensives

13. The GAP between investigator training and investigator performance

14. Results of FDAaudits

15. Solutions for more effective GCP training The training method must parallel the expected performance of the participants.

16. Solutions for more effective GCP training Examples of training with a performance goal in mind.

17. Solutions for more effective GCP training Demonstration of Competency

18. Paul Mastoridis, Pharm D Schering-Plough Corporation Kenilworth, NJ

19. Thinking outside the Box can make a difference Paul Mastoridis, Pharm D Schering Plough Corporation

20. Connect all the dots Using one single pen flow connect with only 4 lines START

21. Solution

22. Thinking Outside The Box • How to Generate Creative Solutions to Your Toughest Challenges: • Whatever challenges you're currently facing, doing things the same old way probably won't overcome them. • In today's ever-changing healthcare climate, we all need to venture beyond our thinking boundaries to find innovative solutions and generate new ideas. • Ideas are not only key to organizational success, they're a must for a successful career!

23. Inside The Box • Thinking inside the box means accepting the status quo. • For example, Charles H. Duell, Director of the US Patent Office, said, "Everything that can be invented has been invented." • That was in 1899: clearly he was in the box!

24. Most of us are inside the box • Most of us like to conform • We like to belong • Social Clubs • Societies/Committees/Associations • We want to be a part • We were trained a certain way • This is how things are done here • We feel comfortable

25. Outside The Box Thinking outside the box requires different attributes that include: • Willingness to take new perspectives to day-to-day work. • Openness to do different things and to do things differently. • Focusing on the value of finding new ideas and acting on them. • Striving to create value in new ways. • Listening to others. • Supporting and respecting others when they come up with new ideas

26. Patch Adams • Thinking Outside the Box

27. So How can we do it!

28. Who are we as educators/trainers • Repetition • Enthusiasm • Understanding • Knowledgeable • Compliance • Are we selling? Buy-in:reason you have to do this • Selling ideas, concepts, services, consequences

29. Who are we as educators/trainers • Reaching out to engage (get info) • Find need before you fill need • Get them talking to you, find something in common • Relating to their needs (give info) • Answer questions directly

31. It all starts with objectives • Why are you training/educating me? • Can you communicate effectively to me? (Rocky Mountains) • What do you intend to accomplish and have them take home? • Follow-up?

32. Knowing your Audience • Who are they? • Where do they come from? • What is their experience? • What are their needs/concerns?

33. Know Your Audience Argentina

34. Know Your Audience • “stuffed” :vulgar/rude connotations in Australia • thumbs-up:vulgar/rude connotations in Australia and Arab world (Newsweek) • winking at a woman, even when being friendly, is inappropriate (Argentinian physician in US ER example) • US: hand shake/kiss once • Greece: kiss twice • Belgium/Paris: kiss thrice • Let’s take a break: let’s take a rupture:French

35. Know Your Audience • Use black and white for materials, colors have great significance for the Chinese • Use open hand rather than one finger to point • Japanese/Germans are very sensitive to status and titles (Kai Stagle) • Left hand is considered unclean in the Arab world

36. Know Your Audience • The O.K. sign and ” I Got your nose sign” as used in the US is considered obscene to the Guatemalans, O.K. means money to the Japanese • Latin American people are warm and friendly and make a lot of physical contact. They often touch shoulders or hold another’s arm, to withdraw from such a contact is considered insulting • Some western gestures convey nothing to the Japanese: shrugging of the shoulders or wink of an eye between friends

37. Know Your Audience • Mexican’s catch another’s attention in public with a “psst-psst” sound. This is not considered rude. • Avoid slang or jargon, especially figures of speech, use short simple sentences, and pause often to make sure that your exact words are understood. • JAPAN-Do Not Touch

38. Know Your Audience-Resources • http://www.executiveplanet.com/index2.jsp • tips for U.S. business travellers on foreign culture and etiquette for selected countries • http://www.hbcollege.com/management/students/bus_etiquette.htm • Test you business etiquette

39. The Bottom Line • Tailor the method of delivery to the expected performance and the patient. • Understand we are a melting pot of countries/ethnicities • People that have an accent or don’t speak English are not stupid nor are they hard of hearing • Be sensitive and understanding, remember what you are there to do • Develop treatment plan specific for each patient

40. Training: techniques and tools • Identify methods to better interact/communicate • Group Response System (Poll-the-Audience) • Great tool to teach/train/educate other healthcare providers

41. The Bottom Line Tailor the method of delivery to the expected performance and the audience.

42. GROUP RESPONSE SYSTEM

43. GCP Training: techniques and tools • Assessment Testing: Pre/Post • Promote a consistent message among investigators and sponsor personnel. • Provide a global question and answer forum. • Know your SOPs, GCPs, ICH guidelines • Encourage open discussions • Keep focused • Work Hard Play Hard

44. GCP Training: techniques and tools • Identify methods to better interact/communicate at Investigator Meetings • Group Response System (Poll-the-Audience)

45. Training Resources • Example: www.raninstitute.com

46. Software to spice up Training/Educating • Gameshow Pro3 Is That Your Final Answer Jeopardy / Family Feud / Tic Tac Toe game shows / Create Millionaire type games shows • Gameshow Presenter - software Create a game show with minimal expense • Classroom Bingo B-I-N-G-O makes classroom learning fun • http://www.trainerswarehouse.com • http://www.trainingsupersite.com Example

47. Summary • Generate creative solutions to your challenges through thinking outside the box ideas • Enthusiasm, Understanding, Knowledgeable, Compliance : keys to who we are and who we can become • Know your audience • Reaching out to engage (get info) • Relating to their needs (give info) • Respond to their needs • Tailor the method of delivery to the expected performance

48. Summary • PRESENTATION PRESENTATION PRESENTATION(Bill Cosby-Steak) • Great resources to make training fun!

49. “You tell me, and I forget. You teach me, and I remember. You involve me, and I learn.” -Benjamin Franklin

50. WORK HARD PLAY HARD • HAVE FUN! • MUSIC: Universal Language • KARAOKE! • http://www.vanbasco.com/ • Midi search engine/software • I want to leave you with just a note