Training Plan Development - CTN Dissemination Library
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Transcript Training Plan Development - CTN Dissemination Library
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
Develops local SOPs
Practices
Role play
Audio-recordings
Standardized participant walk-through
Performance
Applies knowledge in real time
6
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 !!!
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
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
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
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:
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)
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
Introduction
Outline of required trainings
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)
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?
Local Training
Protocol Specific Training
Site
Lead Team
…for ensuring staff is properly trained?
PI
SC
QA
Affirms staff qualifications
Coordinates & documents training completion
Monitors & verifies completion
20
Training Plan
Local 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)
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
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
Local
Protocol Specific Training
Pre-training
National Training
Post-training
Specifies training requirements for each
study staff role
Lists presenters, date, time, length
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
Sites are responsible
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
Pre-Training
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
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
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)
What options
QA monitor verification
work for you?
34
Training Completion Documentation
Regulatory Binder
RTS
Local Training
Pre-Training
Roll Call
Attendance email
National Training
Sign-in Sheet
Roll Call
Attendance email
Post-Training
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
Training is an ongoing process
Need for solid structure and foundation
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
[email protected]
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