2010 Web Seminar Series
Training Plan
Development for
Protocol Implementation
Presented by:
Rosa Verdeja, M.Ed. (Florida Node)
Liz Buttrey (NIDA CTN CCC)
September 29, 2010
Produced by Liz Buttrey, NIDA CTN CCC Training Office
"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."
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

2
Training: An Ongoing Process
THE GOAL
Competency on Performance
3
Transferring Skills Process
Trainer
Feedback
System
Trainee
4
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!

5
Applying the Skills
The Trainee:

Knowledge transfer and ownership
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Develops local SOPs
Practices
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Role play
Audio-recordings
Standardized participant walk-through
Performance

Applies knowledge in real time
6
Feedback Systems
Feedback System:
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Triggers needs for improvement
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Questions from the sites
Quality of data
QA findings
Reminders
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Coach staff along
Listen behind the questions
Identify communication barriers/ use of other venues
Timing of information: relevance impacts learning
Patience !!!
7
Transferring Skills Process
Trainer
Feedback
System
Trainee
THE GOAL
Competency on Performance
8
Setting the Stage
9
Getting Started


Obtain comprehensive protocol knowledge
Work as a team during development phase

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Create a training team
Hold regular development meetings
Determine preliminary modules
Identify presenters
Designate one person from the LT to

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Oversee and coordinate the training development plan
Execute and follow-up on tasks
Maintain training system at a Lead Team level
10
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
11
Keep in Mind

Structure should be solid from inception
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Training Plan
Training Matrix
Common repository for information
E.g., Livelink
 Access to tools and training resources enables
independence

12
Training Tools
13
Defining Terms

Importance of defining terms in the
training plan
 Common
understanding of words
 Acronym mania
14
Training Plan—Answers what?
Protocol Dictates Training Requirements

The training plan must answer:
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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?
15
What Guides a Training Plan

Protocol Dictates Training Requirements


Broad procedural plans
Manual of Operations & Procedures (MOP)


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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

16
Developing a Training Plan
Training Plan Outline

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Introduction
Outline of required trainings
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Local
Protocol Specific
Training Matrix
Measuring competency
Proof of completion
Staff Training Tracking System
Training of new/incoming staff
17
Training Plan—Staff Roles
Develop List of Site Staff Roles
(template suggestion)

Define role responsibility of each site staff (CTN)
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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
18
Training Plan—Type of Trainings

Type of Training Requirements
 Local
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
19
Training Plan
Who is Responsible…?

…for training delivery?
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Local Training
Protocol Specific Training
Site
Lead Team
…for ensuring staff is properly trained?
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PI
SC
QA
Affirms staff qualifications
Coordinates & documents training completion
Monitors & verifies completion
20
Training Plan
Local Training

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Sites must be in compliance with their local IRB
requirements
Lead Team or Node may provide acceptable options for
obtaining local training requirements
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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)
21
Protocol Specific Training
Pre Training
 National Training
 Post Training

… Courtesy of the
Lead Team
22
Training Plan
Protocol Specific Training

Pre-Training
 General
study overview
 Getting a head-start prior to National Training /
Investigators Meeting / All-hands Meeting
23
Training Plan
Protocol Specific Training

National Training Gathering in one
place: meeting of colleagues
 Delivery of protocol specific
 Study implementation procedures
 Study visit procedures
 Documentation
 Regulatory binder, etc
training
 Intervention
(may be hands on)
 Data capturing systems (may be hands on)
24
Training Plan
Protocol Specific Training

Post Training
 Follow-up
on training needs identified during
National Training
 Provide training refreshers
 Deliver specific training closer to specific
implementation date (e.g., before follow-up
study visit)
 Newly developed sessions triggered during
implementation
25
Developing a Training Plan
Training Plan Outline (sample)


Introduction
Outline of required trainings

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
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
Local
Protocol Specific
Training Matrix
Measuring competency
Proof of completion
Staff Training Tracking System
Training of new/incoming staff
26
Training Matrix

Lists Training Modules

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Local
Protocol Specific Training
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Pre-training
National Training
Post-training
Specifies training requirements for each
study staff role
 Lists presenters, date, time, length
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27
Creating a Training Matrix
Sharing a Training Matrix (sample)
 Use
of colors
 Numbering modules
 Definition of symbols (R,S,O)
 R=
Required, S= Suggested, O= Optional
 Version


control
Some dates may be TBD
Ability to add modules for post-training
 Common
repository, (e.g., Livelink) current
version
28
Delivering Training

Local Trainings

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Sites are responsible
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Webinars
Conference Calls/PPT
presentations, videos
Release of MOP
National Trainings
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PowerPoint presentations
Use of audience device
(interactive/assess)
Suggestions/Questions Box
Hands on
Pre-Post Trainings
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Pre-Training
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Webinars
Conference calls
Email messages
On-site training of
newly hired staff

Site Coordinator’s role in
training/ensuring training of
new staff. Tools:
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Training Plan
Training Matrix
Staff Training Completion
Log
Checklists
29
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
30
Measuring Competency
Individual Staff Responsibilities Log
(template)
31
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
32
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
33
Options for Measuring Competency
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Devices for general sessions
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Immediate audience comprehension feedback (polls)
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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)
What options
QA monitor verification
work for you?
34
Training Completion Documentation

Regulatory Binder
RTS

Local Training

Pre-Training
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Roll Call
Attendance email

National Training

Sign-in Sheet
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Roll Call
Attendance email
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Post-Training
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
35
Staff Training Completion Log
Staff Training Completion Log (template)
 Created
using the Training Matrix
 Each site has its own tab
 Site
staff (name and role)
 Node staff (name and role)
 Completion
marks
 Check
marks
 Date of completion
Show the Project
Aware STCL
36
Staff Training Completion Log

Uses of Staff Training Completion Log
 Site
Coordinator uses it to monitor and
document site staff training
 Serves as evidence of training in the site
Regulatory Binder
 QA monitors can easily review
 Lead Team monitors overall training of staff
 Cost-Analysis studies may use it to analyze
amount and time of training
37
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
38
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
39
Wrapping up
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Training is an ongoing process
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Need for solid structure and foundation

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Feedback system
Plan
Matrix
System for measuring competency
Tracking training documentation
Patience !
Tools  see next page
40
Template Tool Box
1.
2.
3.
4.
5.
Site Roles & Responsibilities —Template
Training Plan — Sample
Training Matrix — Sample
Individual Staff Responsibilities Log — Sample
Staff Training Completion Log — 2 Templates
41
Any Questions or Comments
42
Thank You
Rosa E. Verdeja, M.Ed.
National Protocol Implementation
CTN 0032 and Project Aware
Dept of Epidemiology & Public Health
University of Miami Miller School of Medicine
CRB Room 1028,
Tel: 305-243-8028
Rverdeja@med.miami.edu
43
National Drug Abuse Treatment
Clinical Trials Network ∙ Dissemination Library
A copy of this presentation will be available
electronically after the meeting from:
CTN Dissemination Library
http://ctndisseminationlibrary.org
and
NIDA Livelink
https://livelink.nida.nih.gov