Research Fundamentals Question and Protocol Development

Associate Professor Sue Skull Head, CAHS Research Education Program

Deputy Director, Department of Child Health Research, CAHS

14 February 2020

Research Skills Seminar Series | CAHS Research Education Program

Research support, development and governance

health.wa.gov.au/cahs

© CAHS Research Education Program, Department of Child Health Research, Child and Adolescent Health Service, WA 2020 Copyright to this material produced by the CAHS Research Education Program, Department of Child Health Research, Child and Adolescent Health Service, Western Australia, under the provisions of the Copyright Act 1968 (C’wth Australia). Apart from any fair dealing for personal, academic, research or non-commercial use, no part may be reproduced without written permission. The Department of Child Health Research is under no obligation to grant this permission. Please acknowledge the CAHS Research Education Program, Department of Child Health Research, Child and Adolescent Health Service when reproducing or quoting material from this source.

   

Research Fundamentals  

CONTENTS: 

 

1  PRESENTATION .................................................................................................................................. 1 

2  RESEARCH BASICS – ADDITIONAL NOTES AND RESOURCES .............................................................. 18 

2.1  FORMULATING A RESEARCH QUESTION ......................................................................................... 18 

2.2  LITERATURE REVIEW ........................................................................................................................ 18 

2.3  STUDY DESIGN ................................................................................................................................. 18 

2.4  PROJECT PLANNING ......................................................................................................................... 19 

2.5  WRITING A RESEARCH PROTOCOL .................................................................................................. 19 

2.6  DATA MANAGEMENT ...................................................................................................................... 19 

2.7  TRANSLATING RESULTS INTO ACTION ............................................................................................. 19 

3  RESEARCH GOVERNANCE – 21 FEBRUARY ........................................................................................ 20 

4  INTRODUCTION TO GOOD CLINICAL PRACTICE – 6 MARCH .............................................................. 21 

5  2020 SEMINAR SCHEDULE ................................................................................................................ 22 

6  FEEDBACK FORM ............................................................................................................................. 23 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

Research FundamentalsQuestion and Protocol Development

Assoc. Prof Sue SkullHead of CAHS Research Education Program

Research Skills Seminar Series | CAHS Research Education Program

Research support, development and governance

OVERVIEW1. Research and it's purpose

• Conceptual approaches

• The research pathway• The research team and responsibilities

2. Developing ideas a clear question

3. Developing a high quality protocol

"Research is the process of going up alleys to see if they are blind."Marston Bates

1. Why do research?

How do we approach it?

“Research is to see what everybody else has seen, and to think what nobody else has thought”

Albert Szent-Gyorgyi (Nobel Prize for Medicine, 1893-1986)

4

Why do research?

• To obtain quality evidence

• To answer questions that matter

• To make a difference

2

5

Major approaches to research

• Qualitative Methods

• Quantitative Methods

• “Mixed” Methods

6

Features of different methodsQuantitative

• Specify expected outcome

• Meticulously study design

• Numbers, statistics

• Objective: precise measurement

• Classify, count, statistically explained

• Distilled information, can miss context

• Test and generate hypotheses

• Efficient

• Potentially larger numbers

Qualitative

• General idea of outcome

• Design often emerges

• Words, pictures, objects

• Subjective: interpret observations

• Complete detailed descriptions

• Rich information

• Generate hypotheses

• Time consuming

• Small numbers

Relevant Seminar 2020: 27 Nov – Qualitative Research

Which method?

Qualitative vs Quantitative vs Mixed?

What to use depends on your question…

More later.

7 8

Next Steps

The Research Pathway

3

9

•Background Review

•Research Question

•Specify Objectives

•Methodology

•Pilot Testing

•Approvals

•Budget

•Data Collection

•Analysis

•Report Results

•Make a difference!

Time spent here

is time well spent

The Research Pathway

10

The Research Pathway – Before • Background review

• Stakeholder engagement

• Clarify research question

• Specify objectives

• Develop methods

• Pilot test

• Approvals

• Budget Involvement may start at any phase.“I’ve got some great data”Get help as early as possible – and often

11

The Research Pathway – During

• Data collection

• Refine processes – if needed - and resubmit to ethics

• Study monitoring: procedures, training, data management

• Ongoing dialogue with participants, stakeholders

• Data cleaning

• Interim data analysis - sometimes

1111 12

The Research Pathway - After

• More data cleaning

• Data analysis

• Critically Interpret and Summarise findings

• Communicate findings

• Change policy/practice

• New directions?

• Save the World!

12

4

13

The Research Team• Investigators

• Key stakeholders

• Community members*

• Cultural advisors

• Epidemiologist

• Project manager

• Data manager

• Biostatistician

• Communications team

Be inclusive14

ResponsibilitiesMonitoring• Meetings – Project team, IDSMB• Staff – training, professional development• Staff standards – Good clinical practise, data management etc.• Adherence to standard operating projects• Data quality and security• Independent audits• Sponsor and scholarship requirements• Budget trackingCommunication• Participants, partners, sponsors, othersEthics• Reports, amendments, Adverse Events

Relevant Seminars 2020:

21 Feb – Research Governance

6 Mar – Good Clinical Practice

4 Dec – Ethics Processes

14

• 2. Developing an idea:

- ensuring it’s worthwhile

- creating a clear question

“ The measure of greatness in a scientific idea, is the extent to which it stimulates thought and opens up new lines of research.”Paul A. M. Dirac

16

Ideas

• Where do they come from?

• Why be nice to them?

• When is an idea worth pursuing?

16

5

17

All research questions start with ideas

“ Perplexity is the beginning of knowledge.” Khalil Gibran

“ Science does not know its debt to imagination.” Ralph Waldo Emerson18

Why be nice to ideas?

• Ideas need time

• An initial “poor” or “simple” idea can evolve into a worthwhile one

• A well-developed idea then underpins a research protocol

Research Idea Development Forum

Trialled in 2019

Moving to 1:1 approach in 2020 �

CAHS.ResearchSupport@health.wa.gov.au“ Your present circumstances don’t determine where you can go;they merely determine where you start.”Nido Oubein

18

19

So when is an idea worth pursuing?

19 20

Health Research Principles

• Research Merit

• Research Integrity

• Justice, Beneficence and Respect

20

https://www.cdc.gov/tuskegee/timeline.htm

“Whoever is careless with the truth in small matters cannot be trusted with important matters”Albert Einstein

6

21

Researcher Integrity

• Search for knowledge

• Honesty, lack of bias in conduct

• Communicate findings without bias

• Allow scrutiny

Pictured: Andrew Wakefield

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3136032/

“Scientists who publish their research have an ethical responsibility to ensure the

highest standards of research design, data collection, data analysis, data reporting,

and interpretation of findings; there can be no compromises because any error, any

deceit, can result in harm to patients as well harm to the cause of science”22

General Ethical Principles

Justice• Fair selection of participants

Beneficence• Consider welfare and interest of participants

• Risk vs Benefit, equipoise

• Awareness of social implications

Respect• Autonomy of individuals

• Protection of vulnerable groups

“In matters of truth and justice, there is no difference between large and small problems, for issues concerning the treatment of people are all the same” Albert Einstein 22

23

Research Merit• Important question

– After appropriate literature review

– Potential benefit

– Contribution to knowledge/wellbeing

– High risk, high volume, high cost

– Aligned with research priorities*

• Appropriate methods*

• Appropriate skills

“It seems to never occur to fools that merit and good fortune are closely united”Johann Wolfgang von Goethe

23

This is NOT your research team

24

Feasibility

7

25

Feasibility

• Clear question, objectives, outcome measures

• Appropriate study design

• Adequate number of subjects

• Appropriate expertise

• Adequate resources

• � Useful/complete/high quality data

25 26

Clinical Relevance

• Who cares?

• Is this an important problem: personally,

locally, internationally?

• What would your research add?

• Has it been done before?

• What is the likely impact on policy and

practice?

“It is a good morning exercise for a research scientist to discard a pet hypothesis every day before breakfast.It keeps him young.” Konrad Lorenz

26

27

Importance of a good review

Further Reading

Discussion with Experts/Peers/Community

Review Logistics/Resources etc.

Can lead to a whole new question!

27 28

Literature Review

• Constantly evolving technology

• Informationists / medical librarians can assist with:

– Literature review

– Automated searches, alerts

– Critical appraisal

– Reference packages e.g. EndNote

• Do a course, update regularly

• Depth depends on project scope, resources

28

8

29

Basic Critical Appraisal Skills – Essential

Your goal? To determine:

1. Existing knowledge � your project’s contribution

2. Is there a definitive study out there already?

3. Find the “highest level” studies first

4. Ideas for design, data

Critical appraisal is the process of carefully and systematically examining research

to judge its trustworthiness, its value and relevance in a particular context.

(Burls, 2009)

Relevant Seminars 2020:16 Oct – Critical Appraisal of Scientific Literature

23 Oct – Statistical Tips for Interpreting Scientific Claims30

Peer Review

• No excuses! Email, skype, phone

• Generally others are pleased to be asked

• Pay-off…

– Incomplete studies

– Unpublished papers

– Abstracts at recent conferences

– Personal experience

– Insight on implications

– Collaboration

30

31

Community Engagement

• Essential and required

• Pay-off huge…

– Personal experience

– Insights ++ on

• Relevance, Practicalities

• Implications, Data for collection

• Interpretation of results, Plain language

– Advocacy: funding, dissemination

– Collaboration31

Community Engagement Seminar

Fri June 26th or

https://pch.health.wa.gov.au/Research/Fo

r-researchers/ResearchEducationProgram

32

Research Idea Development Support

• Early input � meaningful, well-designed projects

• Get 1:1 advice wherever possible

• Research support

– Research support officers

– Epidemiologists

– Statisticians etc

• Idea development forums

Ensure fit with site research agenda32

9

33

So assuming your idea is a good one…

�Clarify and Develop your Research Question

33 34

PICOT: Clearly Define a Question• Simple evidence-based Clinical Practise tool

• Provides structure with 5 key components

• Idea � answerable research question � design, protocol

Population: who should be in the study

Indicator: intervention or exposure of interest

Comparator: comparison group, baseline, gold standards

Outcome: outcome measurements of interest

Time: time period of interest34

35

Example – A diagnostic question

Population

• In children with probable obstructive sleep

apnoea

Indicator

• Does overnight oximetry testing

Comparator

• Compared with a sleep study

Outcome

• Diagnose obstructive sleep apnoea equally well?

Time

• Over the usual testing period

35 36

Example – A prediction question

Population

• In adolescents with a previous seizure

Indicator

• What risk factors

Comparator

• -

Outcome

• Predict seizure recurrence

Time

• Over a 1 year period

36

10

37

Example – An intervention question

Population

• In children with otitis media

Indicator

• Does antibiotic therapy delayed by 48h

Comparator

• Compared with usual therapy

Outcome

• Increase duration of pain or bulging of the ear drum

Time

• Within 10 days of onset of symptoms

37 38

Choosing the right Study Design

• Certain questions lend themselves to certain designs

• A clear question usually gives

• Balance “best” design with feasibility, resources, ethics

• Quantitative – Qualitative – Mixed Methods

• Check in with an epidemiologist

• Additional resources in handout

38

39

RCT’s

Cohort Studies

Case Control

Cross-Sectional Studies

Case Series, Case Reports

Ideas, Opinions, Editorials, Anecdotal

Study Design

Quality of evidence

Higher

Lower

Risk of Bias

Lower

Higher

Meta -Analyses

Systematic Reviews

39 40

Example – A diagnostic question

40

Population

• In children with probable obstructive sleep

apnoea

Indicator

• Does overnight oximetry testing

Comparator

• Compared with a sleep study

Outcome

• Diagnose obstructive sleep apnoea equally well?

Time

• Over the usual testing period

11

41

Example – A prediction question

Population

• In adolescents with a previous seizure

Indicator

• What risk factors

Comparator

• -

Outcome

• Predict seizure recurrence

Time

• Over a 1 year period

41 42

Example – An intervention question

Population

• In children with otitis media

Indicator

• Does antibiotic therapy delayed by 48h

Comparator

• Compared with usual therapy

Outcome

• Increase duration of pain or bulging of the ear drum

Time

• Within 10 days of onset of symptoms

42

3. Protocol Development

44

The Study Protocol…

• A plan or roadmap outlining everything you will do

– What, why, who, how

• For study team, funders, ethics..

• Background including question, justification

• Methods

• Budget

• Ethics

• More…

44

12

45

Putting together a Protocol – Basics• Outline 1-2 pages of headings � expand

• Get advice – not just for the statistics – early and often

• Be prepared to make this an iterative process

• Remember you have a team

• Can you cut any corners? Standard approaches?

• Data collection forms

• Data management

• Study monitoring

• Community involvement

• Must be a joy to read ☺

45 46

Background

Order of key areas is important

• Problem – why are we here

• Evidence – what we know / don’t

• Justification – impact

• Clear statement of research question

• Objectives / Aim / Hypotheses

Who can help? Librarian/Informationist, Content Experts, Epidemiologist

46

47

Specific Objectives

• Primary objectives

• Secondary objective(s)

• Must clearly match your research question

• Become the basis of 1o and 2o analyses

47 48

Methods

Garbage in = Garbage out

Who can help?

Epidemiologists, other researchers, data managers,

biostatisticians, community experts

48

13

49

Methods Overview• Study design

• Stakeholder involvement

• Setting

• Participants

• Definitions – exposure, outcomes, tests

• Analysis plan, statistical methods, sample size

• Data collection plan and instruments

• Data management plant

• Monitoring and management plan including training

• Piloting

• Timelines, budget, communications / translation plan

• Ethical considerations and application49 50

Community/Site Involvement and Support

• Include key stakeholders – why?

• Consult early

– eg prior to finalising Q, data, study sites etc

• Information sessions

• Seek input to design

• Obtain site support

• Ethics / Governance requirements

– Site specific assessment form, or

– Health access request form

Who can help? Other researchers,community leaders,communications team

50

51

Analysis Plan• No idea?

– Write your paper titles

– Write abstracts

– Identify key variables

– � Collect the data you need

• Answer the research question(s)!

• Consistency with study design

• Outline tables/graphs

• Use appropriate statistical tests and models

• Sample size calculations

Who can help?

Epidemiologist, Biostatistician

52

Simple Descriptive Data

• Participant/case profile

• Denominator Data

• Baselines Tables

The Analysis Plan (Quantitative)

Univariate Analysis

• 1o & 2o Outcomes

• Subgroup Analyses

Multivariate

Analyses

52

14

53

Instrument Design

• Prepare for multiple

iterations

• Unique identifiers

• Simplify: skips, codes,

pre-set categories

Data Collection and Entry

Database

• Unique identifiers

• Compulsory fields

• Ranges, validation

• Security

Pilot!!

Who can help? Epidemiologist, Audit Specialist, Data Manager, other Researchers

Relevant Seminars 2020:1 Apr – Survey Design

31 Jul – Data Management

54

Data Management• Good Clinical Practice requirements

• Data Management Plan (monitor)

– Collection

– Recording

– Security

– Filing, version control

– Backup

– De-identification

– Variable names, data dictionaries

– Storage

Who can help?

Data manager, Epidemiologist,

Other researchers

Seminar:

31 July - Data Management

54

Relevant Seminars 2020:

55

Data Cleaning

Important consideration for timelines, budget

Allow lots of time

• Missing data

• Logical checks: dates, ages, gender, outliers

• Unique fields

• Check a proportion for errors

Data entry packages

• E.g. REDCap, Qualtrix, Epi Info, Stata etc, NOT Excel

• Clean, manipulate, analyse, chart, and keep secure

Who can help?

Data Managers

55 56

Study Monitoring• Meetings

– Research team

– Independent Data Safety Monitoring Board

• Investigator checks on training, quality, data

• Ethics reports, amendments, adverse events

– Investigator responsibility

• Internal audit for high risk studies

• External audit - sponsors

Who can help?

Other researchers,

Ethics, Governance

56

15

57

Piloting your Study• Iron out unforeseen issues

• Streamline processes

• Improve data collection instruments

• Estimate sample size

• Improve funding chances

• Revise and resubmit to ethics

• *Always include in your protocol

57

"There are no secrets to success.It is the result of preparation, hard work, and learning from failure." Colin Powell

Absolutely Essential

Who can help?

Other researchers

58

Timelines• Study design including revisions

• Ethics processes

• Site negotiation / community consultation

• Staff hiring and training

• Database development

• PILOTING

• Subject recruitment

• Data collection period

• Data entering, cleaning, analysis

• Report writing and feedback

• Policy development/changes in practice

Use flow diagrams, Gantt charts,

Project management software

58

Be realistic!

59

The Budget

“An incomplete budget will mean your project is unlikely to be

successfully completed. This has implications for your participants,

you as a researcher, and your institution.

59

A big shopping list to consider…

60

Resource Planning 1• Protocol Development – epi, stats, data, literature review

• Database Development

• Staff*

• Equipment purchase, maintenance

• Clinical/Other tests

• Venue hire, infrastructure, insurance

• Consumables – stationery, postage, phone, printing

• Transport

• Consultancies

• Interpreters

• Training

60*Templates within ethics application forms – all costs above usual activities

16

61

Resource Planning 2• Piloting

• Ethics applications

• Clinical trials insurance

• Meetings and teleconferences

• Data entry, cleaning, and storage

• Statistical analysis and interpretation

• Reporting results

– Feedback to participants

– Conferences

– Publications and reports

• Policy Development61

Don’t forget in-kind costs –everything costs something

62

Communication Plan

Moral and professional responsibility

• Avoid duplication of effort

• Respect your participants, sponsors

• Get feedback

• Impact on policy and practice

Relevant Seminars 2020:27 Mar – Social Media

7 Aug – Oral Presentation

28 Aug – Media and Comms

63

Communication Planning

• During and after the project

• Written and oral

• Outline papers and authorship upfront

• Summary reports

• Conferences, seminars

• Community feedback

“The single biggest problem in communication is the illusion that it has taken place.”George Bernard Shaw

Who can help?

Experienced Researchers,

Media Training Officers,

Communications Team64

Policy and Practice Implications

• May not be what was originally assumed

• Must be budgeted for and followed through

MAKEa difference

Not to be forgotten as time and resources run out!

Who can help?

Key stakeholders,

policy experts

17

Take home messages• Be kind to ideas

• Have a clear, worthwhile question

• Put a good team together

• Be aware of your responsibilities

• Choose a research design that fits

• Protocol detail matters – refine, refine, refine

• Effort early = effort saved

• Pilot, pilot, pilot (everything)

• Seek help early and often

And remember…

Enjoy your research!

Be efficient and avoid the pitfalls through design and planning

67

*Full 2020 Research Skills seminar schedule in back of handouts

Natalie Barber

Researcheducationprogram@health.wa.gov.au

Questions?Upcoming Research Skills Seminars:

21 Feb 12:30 Research Governance A/Prof Sunalene Devadason6 Mar 12:30 Introduction to Good Clinical Practice

Please give us feedback!A survey is included in the back of your handout or complete it online via:

https://is.gd/fundamentals2020

© CAHS Research Education Program,Department of Child Health Research, Child and Adolescent Health Service, WA 2020

Copyright to this material produced by the CAHS Research EducationProgram, Department of Child Health Research, Child and AdolescentHealth Service, Western Australia, under the provisions of the CopyrightAct 1968 (C’wth Australia). Apart from any fair dealing for personal,academic, research or non-commercial use, no part may be reproducedwithout written permission. The Department of Child Health Research isunder no obligation to grant this permission. Please acknowledge theCAHS Research Education Program, Department of Child HealthResearch, Child and Adolescent Health Service when reproducing orquoting material from this source.

 

2 RESEARCH BASICS – ADDITIONAL NOTES AND RESOURCES

2.1 FORMULATING A RESEARCH QUESTION 

Aslam S, Emmanuel P. Formulating a researchable question: A critical step for facilitating good clinical research.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3140151/  

PICO: Formulate an answerable question.  Cochrane Collaboration. http://learntech.physiol.ox.ac.uk/cochrane_tutorial/cochlibd0e84.php  

Asking Focused Questions.  Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/index.aspx?o=1036 

2.2 LITERATURE REVIEW 

Approaches to your Literature Review ‐ E‐Learning Research Methods BMJ. http://www.erm.ecs.soton.ac.uk/theme3/approaches_to_your_literature_review_evaluation.html  

Accessing the PubMed database (and other health resources): http://www.ncbi.nlm.nih.gov/pubmed  

PubMed tutorials are at:   – http://www.nlm.nih.gov/bsd/disted/pubmed.html  – https://learn.nlm.nih.gov/rest/training‐packets/T0042010P.html  

 

Finding the Evidence. Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/finding‐the‐evidence/  

Levels of Evidence. Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/index.aspx?o=5653  

Critical Appraisal Tools.  University of South Australia. http://www.unisa.edu.au/Research/Sansom‐Institute‐for‐Health‐Research/Research/Allied‐Health‐Evidence/Resources/CAT/ 

 

2.3 STUDY DESIGN 

Ioannidis JPA, Greenland S, Hltaky MA et al.  Increasing value and reducing waste in research design, conduct, and analysis. Lancet 383: 166‐75. Jan 14 http://www.thelancet.com/journals/lancet/article/PIIS0140‐6736(13)62227‐8/fulltext  

Aslam S, Georgiev H, Mheta K, Kumar A. Matching research design to clinical research questions. Indian J Sex Transm Dis. 2012 Jan‐Jun; 33(1): 49–53.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326852/  

Checkoway H, Pearce N, Kriebel D. Selecting appropriate study designs to address specific research questions in occupational epidemiology. Occup Environ Med. 2007 September; 64(9): 633–638. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2092571/  

Study designs: strengths and weaknesses. Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/?o=1039  http://www.cebm.net/blog/2014/04/03/study‐designs/   

 

Epidemiological research: the six types of study design you need to know. Student BMJ 2001;09:261‐304 August ISSN 0966‐6494 http://www.vhpharmsci.com/decisionmaking/Therapeutic_Decision_Making/Intermediate_files/Epidemiological%20research‐studentBMJ.pdf 

 

2.4 PROJECT PLANNING 

Eston RG, Rowlands AV. Stages in the development of a research project: putting the idea together. http://bjsm.bmj.com/content/34/1/59.full  

Developing a project plan: Flinders University Planning and Evaluation Wizard. – http://som.flinders.edu.au/FUSA/SACHRU/PEW/pep_intro.htm – http://www.flinders.edu.au/medicine/sites/pew/developing‐a‐project‐and‐evaluation‐

plan/planning‐zone/  

 

2.5 WRITING A RESEARCH PROTOCOL 

Guide for writing a Research Protocol for research involving human participation. WHO. http://hub.ucsf.edu/protocol‐development  

Recommended Format for Writing a Research Protocol.  WHO http://www.who.int/rpc/research_ethics/format_rp/en/  

Writing an Effective Research Proposal.  Verheof MJ, Hilsden RJ.  University of Calgary, Alberta, Canada. 2004 http://www.ais.up.ac.za/health/blocks/block2/researchproposal.pdf 

 

2.6 DATA MANAGEMENT 

Note: The Research Skills Seminar Series has a seminar on Data Management for which materials are available. Data Collection and Management seminar will be presented 31st July 2020.  

WA Health Research. Governance Policy and Procedures Handbook. http://www.health.wa.gov.au/CircularsNew/attachments/724.pdf  Also see the Research Governance Service website for WA for additional information: https://rgs.health.wa.gov.au/Pages/Home.aspx   

Souhami R. Governance of research that uses identifiable personal data.  http://www.bmj.com/content/333/7563/315 

 

2.7 TRANSLATING RESULTS INTO ACTION 

Note: The Research Skills Seminar Series will present a seminar on Knowledge Translation on 22 May 2020.  

How to put the evidence into practice: implementation and dissemination strategies NHMRC 2000 CP71 http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp71.pdf  

How to use the evidence: assessment and application of scientific evidence. NHMRC 2000 CP69. http://www.nhmrc.gov.au/guidelines/publications/cp69 

Research Skills Seminar Series 2020CAHS Research Education Program

Research GovernancePrinciples and Practical GuidanceFriday, 21 February 2020 | 12:30 – 1:30PM

Want to understand better how your 

Governance applications go through the 

Research Governance office for review? 

Confused as to what they are looking for?

This seminar will focus on the general 

principles and responsibilities related to 

research governance, and provide 

practical guidance for preparation of 

governance applications. It will also 

update you on recent changes and 

upcoming developments relevant to this 

process.

*Online access via Scopia available

*Hosted VC Sites Include:CAHS – Community Health (WASON)

Fiona Stanley Hospital

Joondalup Health Campus

Lions Eye Institute

Royal Perth Hospital

Further information:

E: ResearchEducationProgram@health.wa.gov.au

W: pch.health.wa.gov.au/Research/Go to “For Researchers”then “Research Education Program”https://pch.health.wa.gov.au/Research/For-researchers/ResearchEducationProgram

The Research Skills Seminar Series is part of the Research Education Program, Department of Child Health Research,Child and Adolescent Health Service, WA Department of Health.  Seminars are hosted by WA Department of Health.

Perth Children’s HospitalPCH Auditorium

Level 5(Pink or Yellow lifts)

15 Hospital Ave, Nedlands

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ResearchEducationProgram.eventbrite.com

Sunalene Devadason is the Coordinator of Graduate Research at the UWA School of Paediatrics and Child Health (SPACH). She has extensive experience on both sides of research governance process as a reviewer and a researcher.

Assoc. Prof Sunalene Devadason

Introduction to Good Clinical PracticeFriday, 6 March 2020 | 12:30 – 1:30PM

All researchers conducting human research must have undertaken Good Clinical Practice (GCP) training. With regular updates to GCP, it is ideal  to take refresher training to aid in keeping up to date with current requirements.

This seminar is for those unsure what GCP entails and would like to learn more or just wanting a refresher. The seminar will provide a basic understanding of GCP and will cover: responsibilities, approvals, informed consent, document and data management, safety reporting, andreporting adverse effects. 

Natalie Barber is the Head of Research Governance and Platforms at Telethon Kids Institute. Before moving to Australia 6 years ago, Natalie worked within the Pharmaceutical Industry and the NHS in the UK. 

Natalie Barber

She is an experience teacher of GCP and has vastexperience in running clinical trials and human researchwithin multiple disciplines of research and has a breadthof knowledge of the Australian Regulatory landscape.

CAHS Research Education Program | Research Skills Seminar Series

Online access via Scopia available

Hosted VC Sites Include:

CAHS – Community Health (WASON)

Fiona Stanley Hospital

Joondalup Health Campus

Lions Eye Institute

Royal Perth Hospital

Further information: E: ResearchEducationProgram

@health.wa.gov.au

W: cahs.health.wa.gov.au/Research/Go to “For Researchers”Then “Research Education Program”

Perth Children’s HospitalPCH Auditorium

Level 515 Hospital Ave, Nedlands

Register OnlineResearchEducationProgram

.eventbrite.com

https://www.cahs.health.wa.gov.au/Research/For-researchers/Research-Education-Program

CAHS Research Education Program | Research Skills Seminar Series 2020

All sessions held on Friday 12:30 – 1:30pm, Perth Children’s Hospital Auditorium

Date Topic (abbreviated titles) Presenter

1  Feb 14  Research Fundamentals: Question and Protocol Development  A/Prof Sue Skull 

2  Feb 21  Research Governance Sunalene Devadason 

Helen Hughes 

3  Mar 6  Introduction to Good Clinical Practice  Natalie Barber 

4  Mar 13  Scientific Writing  A/Prof Sue Skull 

5  Mar 27 Building your Personal Brand as a Researcher: How to get started 

and maintain momentum on social media Dr Kenneth Lee 

6  Apr 3  Using REDCap for your Data Capture and Management  Telethon Kids Biometrics Team 

7  May 1  Survey Design and Techniques  A/Prof Sue Skull 

8  May 15  Introduction to Adaptive Trials  Prof Tom Snelling 

9  May 22  Knowledge Translation Dr Fenella Gill  

Dr Tobias Schoep 

10  Jun 5 Introductory Biostatistics: Understanding and reporting research 

results including P‐Vales and Confidence Intervals Dr Julie Marsh 

11  Jun 12  Sample Size Calculations  Dr Julie Marsh 

12  Jun 26  Consumer and Community Involvement  Anne McKenzie AM 

13  Jul 31  Data Collection and Management  A/Prof Sue Skull 

14  Aug 14  Oral Presentation of Research Results  A/Prof Sue Skull 

15  Aug 28  Media and Communications in Research  Elizabeth Chester 

16  Sep 11  Conducting Systematic Reviews  Prof Sonya Girdler 

17  Sep 18  Involving the Aboriginal Community in Research Glenn Pearson  A/Prof Sue Skull 

18  Oct 16  Rapid Critical Appraisal of Scientific Literature  A/Prof Sue Skull 

19  Oct 23  Statistical Tips for Interpreting Scientific Claims  Dr Julie Marsh 

20  Nov 13  Grant Applications and Finding Funding  A/Prof Sue Skull 

21  Nov 27  Qualitative Research Methods  Dr Shirley McGough 

22  Dec 4  Ethics Processes for Clinical Research in WA  A/Prof Sue Skull 

Topics may be subject to change; email notice will be provided.

All seminars and corresponding handouts are regularly revised and updated.

Attendance certificates are available upon request.

E: ResearchEducationProgram@health.wa.gov.au W: CAHS Research Education Program (external site)

https://cahs.health.wa.gov.au/ResearchEducationProgram/