"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

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Training: An Ongoing Process

THE GOAL

Competency on Performance

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Transferring Skills Process

Feedback System

Trainer

Trainee

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Transferring the Skills

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

Pre-Post Trainings Webinars Conference calls Email messages

On-site training of newly hired staff

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

CRB Room 1028, Tel: 305-243-8028

Rverdeja@med.miami.edu

Clinical Trials Network ∙ Dissemination Library National Drug Abuse Treatment

A copy of this presentation will be available electronically after the meeting from:

http://ctndisseminationlibrary.org

CTN Dissemination Library

https://livelink.nida.nih.gov

NIDA Livelinkand