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
Ruth Ann Nylen, PhD The RAN Institute Tampa, FL
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
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
Regulatory References • www.ich.org • www.fda.gov • www.regsource.com • www.nih.gov
GCP training requirements for investigators • The protocol • Study-specific requirements • Sponsor expectations Exceptions for Non-IND studies
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
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
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
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
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
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
Solutions for more effective GCP training The training method must parallel the expected performance of the participants.
Solutions for more effective GCP training Examples of training with a performance goal in mind.
Solutions for more effective GCP training Demonstration of Competency
Paul Mastoridis, Pharm D Schering-Plough Corporation Kenilworth, NJ
Thinking outside the Box can make a difference Paul Mastoridis, Pharm D Schering Plough Corporation
Connect all the dots Using one single pen flow connect with only 4 lines START
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!
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!
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
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
Patch Adams • Thinking Outside the Box
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
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
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?
Knowing your Audience • Who are they? • Where do they come from? • What is their experience? • What are their needs/concerns?
Know Your Audience Argentina
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
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
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
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
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
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
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
The Bottom Line Tailor the method of delivery to the expected performance and the audience.
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
GCP Training: techniques and tools • Identify methods to better interact/communicate at Investigator Meetings • Group Response System (Poll-the-Audience)
Training Resources • Example: www.raninstitute.com
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
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
Summary • PRESENTATION PRESENTATION PRESENTATION(Bill Cosby-Steak) • Great resources to make training fun!
“You tell me, and I forget. You teach me, and I remember. You involve me, and I learn.” -Benjamin Franklin
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