Train the Trainer - pipaonline.org · discoveries into novel therapies Innovation ... are important - Explain why it is ... Evaluate if an adverse event meets the ICH GCP

Train the Trainer

Kate Hardstaff Training Manager

Cancer Research UK Centre for Drug Development (CRUK CDD)

Agenda

• Introduction

• The training cycle

• Laying the foundations for a successful training session:

– Assessing training needs

– Writing learning objectives

• Developing training activities

Who are Cancer Research UK?

We are the world’s leading cancer charity dedicated to saving

lives through research

1970

TODAY

SURVIVAL HAS

DOUBLED

CRUK Centre for Drug Development: Our Goal

Tomorrow’s Medicine Today’s Science

We translate

Lab picture

Bring promising new treatments to people with cancer

CRUK CDD: How we work

Saturday, November 15, 2014

Partnership

Delivering progress through partnership:

We collaborate to develop industry and academic discoveries into novel

therapies

Innovation

A pioneering portfolio:

From small molecules and biologics to novel

combinations, we focus on innovation

Centre of excellence

From manufacturing and pre-clinical to full clinical

trial operations, we have the capabilities and

infrastructure needed to demonstrate clinical

potential

Developing anti-cancer treatments that would not happen without our support

What is training?

Learning:

The act, process or experience of obtaining knowledge

or skills

Training:

Planned, structured activity designed to help

an individual or group learn required skills and

knowledge

Examples: classroom based, on-the-job, e-learning etc

Train the trainer: Goals and objectives

Goal: Be able to plan an effective and

engaging classroom based training session

Objectives:

- Write clear learning objectives and explain why these are important

- Explain why it is important to use an active training approach

- Identify appropriate training activities to support learning goals and objectives

What do you think?

When developing a training course, its important to plan to tell participants most of the knowledge you have about that topic

The Training Cycle

ADDIE

Analyse

Design

Develop Implement

Evaluate

Analyse

12

Before designing a training module…

Organisational Participants

Why does my

company need

this training?

What are the

characteristics of

my participants?

What do they

want to learn?

Analyse Training

Need

13

What is an organisational training need? (1)

Organisational

demand for

capability

Existing employee

capability

Difference = Training need

-

14

What is an organisational training need? (2)

Organisational change:

• Process

• Technology

• Regulations

• Job Role

Change in employee capability = Training need

Participant’s Training Needs

Top tips – focus on:

• What do participants need and expect from your

training?

• What do you expect participants to do differently as a

result of attending the training?

Develop objectives

17

The curse of knowledge..

Subject Matter Experts (you!) often want to tell participants everything about their subject...

Avoid this temptation!

Why?

• Overwhelming

• Wastes time

• Boring!

18

Lifting the curse..

Focus on the training need

What is the minimum participants need to know or be able to do to achieve this?

What are training goals and objectives?

Goal Objective

Be able to plan an

effective and engaging

classroom based training

session

Write clear learning

objectives

Identify appropriate

training activities to

support learning goals

and objectives

20

Why are learning objectives important?

• Focused training module design

• Focus learners on the purpose of the module

• Measure training module success

• Purpose of the training module clear to

stakeholders

21

Tips for writing learning objectives

• Specify exactly what the participant will be able to do

at the end of the module?

• Minimise knowledge for knowledge sake

• Use an observable action verb to specify results

• Relevant:

WHY do participants need to know/be able to do this?

Activity: Is this a good learning objective?

The goal of this activity is to reinforce what makes a good learning objective

Vote using Yes and No cards

Be prepared to justify your answers

Is this a good learning objective?

For a course to review safety data reporting for new CRAs

At the end of the course participants will be able to:

Evaluate if an adverse event meets the ICH GCP definition of a serious adverse event


For a course for PV staff on updates to PV practice from the EMA


• Be aware of the updates on PV practice from the EMA

Better learning objectives..

Be aware of the updates on PV practice from the EMA

• Describe the updated EMA advice on PV practice

• Apply the updated EMA advice to real life PV reporting scenarios

For a course for PV staff on updates to PV

practice from the EMA


From a course for CRAs on SAE reporting, prompted by site staff not completing SAE forms correctly (missing and incomplete information)


• Understand how site staff should complete an SAE report form


From a course for CRAs on SAE reporting, prompted by site staff not completing SAE forms correctly (missing and incomplete information)

Understand how site staff should complete an SAE report form

• Describe how to complete an SAE report form

• Identify common errors when completing SAE report forms and explain how to prevent these


For a course on the impact of the new EU clinical trials directive on PV reporting

• In this course, we’ll demonstrate to you how to use the new EU portal to report SUSARs to the MHRA


For a course on the impact of the new EU clinical trials directive on PV reporting

In this course, we’ll demonstrate to you how to use the new EU portal to report SUSARs to the MHRA

• At the end of this course you’ll be able to report SUSARs to the MHRA using the EU portal



At the end of this course, you’ll be able to:

- Explain the history behind the development of the global regulations on drug safety reporting

Better learning objectives



- Explain the history behind the development of the global regulations on drug safety reporting

No objective needed



- Write clear learning objectives

- Describe why writing a clear learning objectives is important

Activity: • The goal of this activity is to practice writing clear

learning objectives

• For a training course that you might develop:

- Identify:

• Name of the course

• Audience

• Organisational goal of the course

– Write:

• Two learning objectives

• Share your thoughts with your neighbour!

Design Materials

35

Lectures/PowerPoint: The case against

36


Learning, unfortunately, is not an automatic consequence of pouring information into another persons head. It requires the persons own mental processing…

Lectures put participants in a position of

sustained, passive listening…

Lecturing by itself will never lead to real learning

Active Training, Mel Silberman

37


The average adult concentration span is

20 minutes

Implication: Use the same delivery method for more

than 20 minutes and…..

38

Lectures/PowerPoint: The case for

• Lectures:

• Efficient

• Low cost

• Useful to get allot of information across quickly

• Good for very experienced audiences

• PowerPoint allows a permanent record of material:

• Ease of repeat delivery

• Materials for participants

• Provides evidence that staff have been trained

39

The trainers challenge, minimise..

40

Why is active learning important? (1)

• Maintain attention: Increases interest and energy

• Increased retention of material

• Increased buy in to new concepts:

People don’t argue with their own data!

• Allows participants to practice/apply new

skills/knowledge in a safe and supported environment

41

Why is active learning important? (2)

• Allows assessment of learners knowledge, skills and

attitudes

• … and allows the trainer to address issues raised

(feedback)

• Allows ideas and experience to be shared

• Increased application of new skills/knowledge on the

job

What activities can you use in training courses?

What activities can I use? Some examples

• Case studies

• Guided questioning

• Simulations of real life activities

Case studies

What: A real or fictional situation presented to participants to analyse and recommend solutions.

Example:

A description of an adverse event scenario for a patient – participants decide if its an SAE and a SUSAR

Excellent for allowing the application of knowledge in real life scenarios

Guided questioning

What: Ask questions to tap into existing knowledge of group, rather than present information

Examples:

What makes an adverse event serious?

What should a CRA train site staff in with regards to safety data?

Excellent for drawing out existing knowledge and building on this.

Simulations

What: A training environment that closely represents the real environment allowing participants to practice skills.

Examples:

Perform SAE reconciliation using data listings from the DM and PV databases

Enter mocked up SAE data onto a training PV database

Gold standard as allows practice of real life skills which allows feedback and increases transfer on the job.

47

Factors to consider when choosing activities (1)

• Does the activity assist with accomplishing the key

learning objectives?

• Does the activity have real world relevance?

• What is the time investment:

• Perform/feedback in class?

• Develop the materials?

• Appropriate for group size?

48

Factors to consider when choosing activities (2)

• Group comfort factor?

• Will the learning be straightforward?

• Consider timing and sequencing

• Test the activity

Activity • The goal of this activity is to decide which learning

activities are appropriate for a training session

• Work in pairs

• Review the statements and answer True or False

• Be prepared to share your answers with the group

Activity

• The goal of this activity is to give you further practice in selecting suitable training activities for your course

• Choose an appropriate training activity for the course you wrote objectives for

• Share your answer with the person next to you for feedback.

Review

ADDIE

Analyse

Design

Develop Implement

Evaluate

Train the trainer: Goals and objectives

Goal: Be able to plan an effective and

engaging classroom based training session

Objectives:

- Write clear learning objectives and explain why these are important

- Explain why it is important to use an active training approach

- Identify appropriate training activities to support learning goals and objectives

Thank you!

Train the Trainer - pipaonline.org · discoveries into novel therapies Innovation ... are important - Explain why it is ... Evaluate if an adverse event meets the ICH GCP

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