"This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271200522081C." 2010 Web Seminar Series Produced by Liz Buttrey, NIDA CTN CCC Training Office Training Plan Presented by: Rosa Verdeja, M.Ed. (Florida Node) Liz Buttrey (NIDA CTN CCC) September 29, 2010 Development for Protocol Implementation
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"This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271200522081C."
2010 Web Seminar Series
Produced by Liz Buttrey, NIDA CTN CCC Training Office
Training Plan
Presented by:Rosa Verdeja, M.Ed. (Florida Node)
Liz Buttrey (NIDA CTN CCC) September 29, 2010
Development for Protocol Implementation
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Presentation Outline
The Training Process Goal of training Understanding the process of transferring skills Setting the stage
Tools Developing a training plan Creating a training matrix Measuring competency Tracking training completion
The Trainer: Plans the training Identifies subject matter experts Develops written reference materials
(& updates) Implements a Model-Practice-Feedback system Tracks overall training completion Needs Patience!
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Applying the Skills
The Trainee: Knowledge transfer and ownership
Develops local SOPs Practices
Role play Audio-recordings Standardized participant walk-through
Performance Applies knowledge in real time
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Feedback Systems
Feedback System: Triggers needs for improvement
Questions from the sites Quality of data QA findings
Reminders Coach staff along Listen behind the questions Identify communication barriers/ use of other venues Timing of information: relevance impacts learning Patience !!!
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Transferring Skills Process
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THE GOALCompetency on Performance
Feedback System
Trainer
Trainee
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Setting the Stage
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Getting Started
Obtain comprehensive protocol knowledge Work as a team during development phase
Create a training team Hold regular development meetings Determine preliminary modules Identify presenters
Designate one person from the LT to Oversee and coordinate the training development plan Execute and follow-up on tasks Maintain training system at a Lead Team level
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Getting Going
Heavy Front-load work Develop training plan *
Develop staff training requirements matrix * Develop manual of operations & procedures
(MOP) Identify & coordinate presenters Develop training timeline
great deal of coordination Develop & maintain training completion log *
for training verification
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Structure should be solid from inception Training Plan Training Matrix
Common repository for information E.g., Livelink Access to tools and training resources enables
independence
Keep in Mind
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Training Tools
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Defining Terms
Importance of defining terms in the training plan
Common understanding of words Acronym mania
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Training Plan—Answers what?
Protocol Dictates Training Requirements The training plan must answer:
Who are you training? What are the required training topics? Who is responsible for delivering training? How/Who is assuring competency? How is training completion documented? How/Who is tracking training completion? How/Who trains incoming staff members?
?
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What Guides a Training Plan
Protocol Dictates Training Requirements Broad procedural plans
Manual of Operations & Procedures (MOP) Outlines specific step-by-step study procedures Guides protocol-specific training needs Importance of versions and change logs
Should trigger training needs Appendices
Address refreshers Reduce MOP versions
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Developing a Training Plan
Training Plan Outline Introduction Outline of required trainings
Local Protocol Specific
Training Matrix Measuring competency Proof of completion Staff Training Tracking System Training of new/incoming staff
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Training Plan—Staff Roles
Develop List of Site Staff Roles(template suggestion)
Define role responsibility of each site staff (CTN) Site Principal Investigator (PI) Site Study Coordinator (SC) Site Research Assistant (RA) Site Interventionist/counselor Site nurse, physician, etc Other (e.g., receptionist?)
Define role responsibility of each node staff University PI Node Quality Assurance (QA) monitor
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Training Plan—Type of Trainings
Type of Training RequirementsLocal Training
Local IRB requirements Required of all study staff in order to conduct quality
research with human subjects (HSP) (GCP) Must issue a certificate
Other (e.g., Universal Precautions)Protocol Specific
Introductory Pre-training National Training/Investigator Meeting Post training
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Training Plan Who is Responsible…?
…for training delivery? Local Training Site Protocol Specific Training Lead Team
…for ensuring staff is properly trained? PI Affirms staff qualifications SC Coordinates & documents training completion QA Monitors & verifies completion
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Training PlanLocal Training
Sites must be in compliance with their local IRB requirements
Lead Team or Node may provide acceptable options for obtaining local training requirements Human Subjects Protection (HSP) Good Clinical Practice (GCP) Universal Precautions, etc.
Training Plan should provide a general description of each local training requirements module
Training Plan specifies required evidence of completion RTS: keeper of regulatory evidence (HSP, CV, License)
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Protocol Specific Training
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Pre Training National Training Post Training
… Courtesy of the Lead Team
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Training PlanProtocol Specific Training
Pre-TrainingGeneral study overviewGetting a head-start prior to National Training /
Investigators Meeting / All-hands Meeting
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Training PlanProtocol Specific Training
National Training Gathering in one place: meeting of colleaguesDelivery of protocol specific training
Study implementation procedures Study visit procedures Documentation Regulatory binder, etc
Intervention (may be hands on)Data capturing systems (may be hands on)
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Training PlanProtocol Specific Training
Post TrainingFollow-up on training needs identified during
National TrainingProvide training refreshersDeliver specific training closer to specific
implementation date (e.g., before follow-up study visit)
Newly developed sessions triggered during implementation
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Developing a Training Plan
Training Plan Outline (sample) Introduction Outline of required trainings
Local Protocol Specific
Training Matrix Measuring competency Proof of completion Staff Training Tracking System Training of new/incoming staff
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Training Matrix
Lists Training Modules Local Protocol Specific Training
Pre-training National Training Post-training
Specifies training requirements for each study staff role
Lists presenters, date, time, length
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Creating a Training Matrix
Sharing a Training Matrix (sample)Use of colorsNumbering modulesDefinition of symbols (R,S,O)
R= Required, S= Suggested, O= OptionalVersion control
Some dates may be TBD Ability to add modules for post-training
Common repository, (e.g., Livelink) current version
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Delivering Training
Local Trainings Sites are responsible
Pre-Training Webinars Conference Calls/PPT
presentations, videos Release of MOP
National Trainings PowerPoint presentations Use of audience device
(interactive/assess) Suggestions/Questions Box Hands on
Site Coordinator’s role in training/ensuring training of new staff. Tools:
Training Plan Training Matrix Staff Training Completion
Log Checklists
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Measuring Competency
It is ultimately the Site PI the one responsible for ensuring that site study personnel are trained and qualified to perform the assigned study responsibility
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Measuring Competency
Individual Staff Responsibilities Log (template)
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Measuring Competency
Individual Staff Responsibilities Log (template)
With my signature, I affirm the above staff member is trained and qualified to perform the responsibilities I have assigned to him/her for this protocol.
Site PI Signature Site PI Printed Name Date
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Measuring Competency
Individual Staff Responsibilities Log (template)
With my signature, I affirm the above staff member is trained and qualified to perform the responsibilities I have assigned to him/her for this protocol.
Site PI Signature Site PI Printed Name Date
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Options for Measuring Competency
Devices for general sessions Immediate audience comprehension feedback (polls)
Allows presenter to correct information on the spot Individualize comprehension assessment
Checklists, observations, write-evaluation for specific intervention training
Quizzes after presentations Quizzes based on MOP (survey monkey?) Randomized Participant walkthrough PI & SC role in supervision (honor system) QA monitor verification What options
work for you?
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Training Completion Documentation
Local Training
Pre-Training
National Training
Post-Training
Regulatory Binder RTS
Roll Call Attendance email
Sign-in Sheet
Roll Call Attendance email
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Staff Training Completion Log
Staff Training Completion Log (template)
Created using the Training MatrixEach site has its own tab
Site staff (name and role) Node staff (name and role)
Completion marks Check marks Date of completion
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Show the Project Aware STCL
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Staff Training Completion Log
Uses of Staff Training Completion Log Site Coordinator uses it to monitor and
document site staff trainingServes as evidence of training in the site
Regulatory Binder QA monitors can easily reviewLead Team monitors overall training of staffCost-Analysis studies may use it to analyze
amount and time of training37
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Evidence of Training Staff Training Completion Log Regulatory binder & RTS (Regulatory Tracking System EMMES)
CV’s for e/ investigator listed on the Appropriate licenses for e/investigator listed IA Certification of Human Subject Protection (HSP) Individual Staff Responsibility Log * Signature Sheet & Delegation of Responsibility Log
(keep updated) * Access to data capturing systems (EDC)
Electronic signature form (designed by individual vendor
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New Staff Training
Staff hired as addition or replacement after the national training
Site Coordinator oversees training: Follows the training plan Uses the training matrix Updates Staff Training Completion Log
Use of a site “master trainer” for specific training needs
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Wrapping up
Training is an ongoing process Feedback system
Need for solid structure and foundation Plan Matrix
System for measuring competency Tracking training documentation Patience ! Tools see next page
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Template Tool Box
1. Site Roles & Responsibilities —Template2. Training Plan — Sample3. Training Matrix — Sample4. Individual Staff Responsibilities Log — Sample5. Staff Training Completion Log — 2 Templates
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Any Questions or Comments
?
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Thank YouRosa E. Verdeja, M.Ed.
National Protocol ImplementationCTN 0032 and Project Aware
Dept of Epidemiology & Public HealthUniversity of Miami Miller School of Medicine