T 79 Investigator and Coordinator Training at the Site

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T 79 Investigator and
Coordinator Training at the Site

• Investigator and Coordinator Training
• at the Site
• Pam DeWeese, MAT, CCRP
• Administrative Director
• Clinical Trials Program
• Indiana University

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Reasons to offer training

• New staff orientation
• Roles and responsibilities change
• Rules and regulations change
• Some training in mandated
• Fundamental element of QA/QI program
• To correct problems
• Best Practice
• Professional development

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Characteristics of Successful Programs

• Its not just about the food ?

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Characteristics of Successful Programs

• Participants value the content
• relevance to their work and needs
• Good organization
• Sensitivity to time
• Start on time Not too long Time of day
• Reference materials to take with them
• Varied presenters and methods of presentation
• Evaluate themselves, sessions, presenters
• Reasonable costs, locations, and times

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Logical first steps

• 1. Identify
• Programs that are already being offered
• Needs
• Topics of interest
• Optional vs mandatory
• Credits
• Certification CME (and their requirements)
• Target audience
• Resources and support
• Others with whom to partner
• people, money, time
• Frequency
• Potential venues
• Types of sessions
• Lecture, interactive, web-based, teleconference,
  one-on-one
• Cost effective ideas
• e.g. how to advertise

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Logical first steps

• 2. Decide on program content/topics
• This can be an evolving process
• 3. Identify potential speakers
• 4. Get something scheduled !

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Logical first steps

• Make arrangements
• Create management tools
• Evaluations
• Sign in sheets
• Registration methods
• Reserve room
• Advertise
• Food
• Print handouts
• Obtain CME approval, if appropriate

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• 6. Just Do It !

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• Evolution
• Examples
• Experience
• Clinical Trials Program
• Indiana University

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Identified programs that were already being
offered

• Research Coordinator Education Program
• 3 day program optional 2 times per year
• Budgets contracts for industry sponsored trials
• Optional occasional 1 or 2 x/yr
• Intro to Clinical Research
• Optional 1-2 times per year
• Grand Rounds
• Optional weekly
• Various therapeutic area talks
• Occasional disease process specific often
  dept-specific
• Coordinator Luncheon
• Quarterly optional random topics of potential
  interest

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Identified Needs

• Year One
• surveyed the research coordinators
• Provided some options
• Asked them to offer additional suggestions
• Asked about optimal time of day and length
• Ranked responses
• solicited ideas from a few other key individuals
• Associate Dean for Research Support
• Director of Research Compliance
• Select business managers

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Results

• 57 Quality Improvement Strategies
• 48 IRB Submissions
• 47 Consent
• 45 Source Document Case Report Forms
• 40 Budget Negotiation Account Maintenance
• 39 Computer Basics
• 38 Adverse Event Reporting
• 34 Contract Negotiations
• 31 Initiating and Closing Out a Study

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Sample write-in suggestions

• Time management-networking sessions for
  coordinators
• Audits -what to expect, how to prepare
• Please dont always hold these on the same day of
  the week
• Investigator Initiated Trials differences
  between industry/Investigator Initiated/NIH
  sponsored studies
• Adverse event scenarios
• Fun/comic/humorous meetings with lunch/food
• Building team spirit/moral on research studies

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• Identified the most frequently occurring requests
  recommendations
• Considered whom we might engage as presenters
• (besides ourselves)
• out of the goodness of their hearts no - ?
• Research Compliance Administration (IRB)
• Schools compliance officer (HIPAA)
• Contracts Officer (Contracts office)
• Commercial sponsors (Initiating/Closing out a
  study GCPs)
• Other coordinators on campus (QA)
• OHRP Director (Recent developments)
• Began developing plans to offer programs based on
  identified topics
• And trying to find room space!

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Subsequent years

• Considered
• Evaluation results
• Highly rated programs considered for repeat
  performance
• Write-in suggestions/comments
• Needs
• New requirements, e.g. HIPAA, IRB form changes
• Frequently reported problems
• New staff
• Speaker availability or opportunity
• Requests/suggestions

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In general

• There seemed to be many options on campus to hear
  about disease-specific issues or current research
  in certain therapeutic areas
• There were far fewer regularly occurring sessions
  on clinical research regulations, management, and
  best practices
• There was considerable interest, particularly
  among Research Coordinators

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Optional vs Mandatory

• At first - Optional
• We had no stick
• We wanted to promote collegiality and helpfulness
  
• Later - some became mandatory
• We convinced the School of Medicine to make the
• 3-day (already existing) RCEP mandatory for all
  new coordinators with lt2 yrs experience
• We partnered with others who needed to provide
  mandatory training
• Our venue/audience helped meet their goals
• Their topic was of interest need to our
  audience
• e.g. HIPAA Security and Privacy IRB changes
• Win-win

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Credits

• Many attendees were interested in credits for
  certification purposes
• We arranged for CME credits for many of our
  sessions
• Broader appeal to physicians
• Acceptable to other professional societies
• Extra work/forms for us
• This year we partnered with SoCRA and ACRP local
  chapters to co-present a topic of interest
• SoCRA/ACRP credits
• We shared the burdon of arrangements
• Due to the draw, we were able to secure an
  industry sponsor to provide
• two sessions
• lunch and dinner
• great speaker from their national headquarters

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Audience

• We try to appeal to
• clinical research investigators
• research coordinators
• business managers
• young faculty/fellows
• We usually attract
• A mixture of the above
• Primarily coordinators
• Average attendance
• 30
• Some mandated sessions were standing room only
• forced us to add sessions for some topics

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Sensitivity to Audience

• Start on time/End on Time
• reward those who show up on time
• (not those who arrive late)
• Typically 1.5 hr 12-130 pm often on Fridays
• Repeat important/popular sessions and vary the
  times/days
• For example
• We offered 6 sessions on HIPAA in Research
  training
• 7am, mid-day, and 5 pm
• Change venue, if necessary
• Scheduled one room for the entire year (necessity
  familiarity) that allowed food (brown bag
  lunches)
• When large crowds were anticipated, tried to
  schedule the larger auditorium

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Cost

• Free
• We use primarily internal experts as speakers
• Outside speakers volunteer their time
• The goal is education not money-making
• Exceptions
• 3 day mandatory coordinator training
• SON Partner (Office of LLL) charges fee for CEUs
  materials
• 2 day grant writing seminar
• Outside guest speaker who charges a fee

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Frequency

• Initially, we offered about 6 sessions per year
• Last year
• Goal - kick it up a notch - monthly
• Actual 23 sessions
• This year
• Created a special interest group for research
  managers
• Added 1 hr. monthly lunchtime meetings targeting
  the special needs of research managers
• Forum for internal discussion, problem solving,
  heads up, or targeted interaction with
  university officials
• Work in progress

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Advertising

• Clinical Trials Program website
• http//medicine.iupui.edu/ctp/invest.html
• School of Medicine weekly newsletter
• IRB newsletter
• Coordinator list-serve
• (all free)

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Evaluation

• We used the CME required format

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• PROGRAM EVALUATION
• SAStrongly Agree AAgree UUndecided
  DDisagree SD Strongly Disagree
• 1. The program was well-organized
• 2. The speakers communicated effectively
• 3. The content was appropriate
• 4. The speakers and presentations demonstrated
  independence,
• objectivity, balance, and professionalism
• 5. The program met the overall stated
  objectives (listed below)
• 6. The content was up to date
• 7. The content was closely related to the
  requirements of my clinical
• research and/or work setting
• 8. The program met my professional
  expectations and needs
• 9. I expect to apply the information/skills
  learned from this program to my
• clinical research projects
• 10. I would recommend this program to my
  colleagues.

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• Suggested topics for the future, suggested
  speakers, /or ways I can help
• 1.________________________
  2._________________________
• 3.________________________
  4._________________________
• Comments ________________________________
  ____________
• Objectives
• 1. Identify discuss a current issue or topic
  related to clinical research or its appropriate
  conduct.
• 2. Present educational information and materials
  to enhance performance and/or confirm accuracy of
  current performance, as a clinical researcher,
  research coordinator, or related support person.
• 3. Provide practical application guidance and
  answer questions from the audience.

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Training Methods

• People generally remember
• 10 of what they read
• 20 of what they hear
• 30 of what they see
• 50 of what they hear and see (lecture)
• 70 of what they see and write (note taking)
• 90 of what they say and do (role play/practice)
• SoCRA Source May 2005

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There is Value in Variety

• (In all honesty) the majority of our group
  sessions are lectures using PowerPoint
  presentations
• Why? Ease, cost, consistency
• Alternates/Technology used
• CD-ROM (e.g. Haz-Mat handling)
• Offers certification
• Very long (gt2hrs) flexibility of own work
  station
• Med library willing to purchase and handle
  check-out
• Interactive hand held electronic device to
  tabulate answers during presentation
• Movie embedded in power point presentation
• Electronic game software Research Jeopardy
  Game
• One-on-One

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One on Onea.k.a. hand holding ?

• Clinical Trials Program (CTP)
• Office of Clinical Research Support
• Medical Director active clinical investigator
• Administrative Director former research
  coordinator and research manager/administrator
• Research Consultant former research nurse and
  independent monitor
• gt 50 years of combined experience !!

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We are available to meet individually or with
small groups

• At their request and sometimes at the IRBs
  suggestion
• Regarding anything dealing with clinical
  research management, regulations, or best
  practices, e.g.
• Help organizing a regulatory binder
• How to do a study budget
• Preparing for an FDA audit
• How to complete IRB forms
• How to file an IND
• I just took over this study and I cant find
  anything
• What do you mean I have to register my study?
  How do I do that?
• How to prepare a corrective action plan and
  letter to the IRB

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Why do staff use our service and come back?

• We approach their problems with an educational,
  not punitive, mentality
• We act as consultants
• Our goal is to teach them how to handle the
  situation themselves. (We are not a fee for
  service provider.)
• Recommend corrective actions preventative
  maintenance for the future
• Assistance topic is individualized and
  client-driven
• We have no sticks
• No charge
• They trust us
• Positive previous experience
• Maintain their confidentiality

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• We dont over react (Little shocks us anymore)
• We believe that most people want to do things
  right, but they may
• have had limited training
• be overwhelmed, and/or
• need someone to help them calm down and
  methodically move forward
• (we think out loud for them)
• We have great working relationships with
  compliance offices on campus
• We work behind the scenes to help them look
  better

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DATA
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Sample Notices

• Date 4/23/04
• Title HIPAA and Medicare Update
• The impact of HIPAA and Medicare on clinical
  research
• Time 12 - 130 PM
• Place Tudor Auditorium Wishard Hospital 5th
  floor
• Cost None
• Registration at the door
• CMEs 1.5
• Presenters Heather Gipson, Compliance Analyst
• Leslie Pfeffer, Compliance
  Training Specialist
• Pam DeWeese, Clinical Trials
  Program Director
• Content Functional requirements and minimum
  expectations How these laws have impacted
  research and operations at IUPUI What does the
  future hold? How to incorporate these
  requirements into your IRB submissions,
  recruitment, budget development, electronic data,
  and billing.

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• Date 5/7/04
• Title Consent and Recruitment Processes
• Time 12 - 130 PM
• Place Tudor Auditorium - Wishard Hospital 5th
  floor
• Cost None
• Registration Registration at the door
• CMEs 1.5
• Presenter Gail Douglas, Clinical Research
  Consultant (CTP)
• Pam DeWeese, CTP Director
• Representative from industry
• Content Appropriate consent and recruitment
  processes Dos and donts Possible strategies
  Expectations of industry Institutional and
  regulatory requirements The impact of HIPAA.

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2004 DATA

• SESSIONS 23
• ATTENDEES 1190
• Evaluation good or excellent 98

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Sample Education and Training Program Titles

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• SOS for IRB Forms
• Research Coordinators Education Program A
  comprehensive training course for new research
  coordinators at Indiana University
• Intro to Clinical Research an overview of the
  clinical research process with an emphasis on
  resources for seeing a project from idea to
  completion
• HIPAA and Medicare Update for Clinical
  Researchers A refresher course regarding the
  impact of HIPAA and Medicare on clinical research
• Consent and Recruitment Processes
• Certification Exam Preparation Class
• Adverse Event Reporting
• Industry-Sponsored Research Budgets and
  Contracts Your Need-To-Know Guide to Success
• Source Documents Case Report Forms If its not
  documented - it didnt happen
• Quality Improvement Strategies

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• Intro to Clinical Research an overview of the
  clinical research process with an emphasis on
  resources for seeing a project from idea to
  completion
• Grant Writing Seminar
• Computer Basics Using EXCEL to Manage Research
  Related Information 
  
• The Federal Perspective on the Conduct of
  Research Involving Human Subjects from OHRP
  Leadership
• Central Lab Processing
• Research Requirements at the VA
• Changes in Human Subjects Protection and IRB
  policies, processes and forms as the result of
  accreditation
• HIPAA security and FDA 21 CFR 11 Impact on
  Clinical Research
• Good Clinical Practices (GCP) Basic Concepts
• Good Sites and Why We Come Back A Sponsors
  Perspective

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In Summary.

• Knowledge is Power
• In order to be truly valuable, knowledge must
• be shared.
• Therefore education and training are valuable.

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Thats All Folks !
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• Pam DeWeese, MAT, CCRP
• Administrative Director
• Clinical Trials Program
• Indiana University
• 1001 W. 10th Street, OPW 526
• Indianapolis, IN 46202
• 317-278-2865
• pdeweese_at_iupui.edu