Resource Modeling – What’s the Right Formula?

Gail Grant, RN, BEc Emeritus Research

Donna Campbell

Cardiology Research Unit Barwon Health - University Hospital Geelong

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Faculty Disclosure In  compliance  with  ANCC  Guidelines,  I/we  hereby  declare:  

 I/we  do  not  have  financial  or  other  rela>onships  with  the  

manufacturer(s)of  any  commercial  service(s)  discussed  in  this  educa>onal  ac>vity.  

 Gail Grant

Research Manager – Emeritus Research

Donna Campbell Research Manager (Senior Advisor) Geelong Cardiology Research Unit

Overview •  Site Models •  Brief History of ER & GCRU •  Resources and Allocation •  What We All Know… •  The Way Forward… •  “Right Formula” •  Discussion/Questions

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Site Models •  Site Management Organization (SMO) •  Investigative Site Network (ISN) •  Site Alliance or Consortium •  Freestanding Research Centre •  Hospital Based Research Unit

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Emeritus Research •  Established May 2000 •  Director - A/Professor Stephen Hall •  Freestanding research centre •  Evolved from a private practice

Rheumatology Research Setting •  Adopted a centralised model

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Establishing a Site

•  Resources – Human - Physical •  SOPS / Systems / Processes •  Training / Education / Mentoring •  Clinical Trials •  Recruitment

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Resource - Human THE TEAM:

  1 CRM – General Management, Study Allocation, Ethics, Finances/Budget, Feasibility, Contracts, SOPs, HR, Equipment Maintenance etc.   4 CRC - F/T; 1 CRC - P/T (4 Days) – Division 1 RN   1 Admin. - accounting, tracking study visits/payments,

software designed for this purpose   5 Investigators – 2 Rheumatologists and 3 GPs

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Human Resources  CRC (the most important study staff…..)  SKILLS  OCD (in moderation)

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Investigators (minor players, but essential☺)

Principal Investigator …the life he hopes for

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Perfect PI - the life we hope for!

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Resource Allocation •  Project Allocation List – assess workload CRC/

Protocol/Status/Enrolled/Back-up CRC •  Study Status Spread Sheet – primary CRC •  Each study is assigned a primary CRC and a back-

up CRC •  Others roles – IP, Independent Assessor •  Training/Mentoring/Education/QA – Janene Richards

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Resources •  SOPs •  Systems/Processes/Templates

•  Induction/Training »  ER Induction Manual New Staff

»  ER Training Manual For CRC & Investigators

•  Education – ongoing

•  GCP – all roads lead to…..

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GCP •  The next GCP session means you'll be

qualified •  You can rest assured you'll never be

disqualified •  Just nine times before? •  Please try not to snore. •  What is the problem? •  You seem not to be mollified. 13

Appreciation of the importance of their role

in advancing medical treatments and improving the QOL for the study participants.

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Engaging & Empowering Staff

Engaging & Empowering Staff

•  Ownership of The Study •  Culture Continuous Improvement •  Environment - Open Discussion •  Teamwork - Support Colleagues •  Encouraged to Contribute •  Weekly Staff Meetings •  Staff Presentations

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Annual ER Day – close the office Staff choose an activity

 Food tour/lunch  Cooking class/lunch Birthday’s Xmas Lunch

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Engaging & Empowering Staff

Clinical Trials

•  Site /Sponsor Relationship

•  Pfizer – “Inspire Site” •  Quintiles

•  Eli Lilly

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And In The Public System……?

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Geelong Cardiology Research Unit – A hospital-based research unit.

•  Background - RN, CCU, Epid & Biostats, Dip of Business -Clinical trials experience at the BMRI in Melbourne & in Industry as CRA

•  Hospital based Research Unit established June 2000 •  A/Prof John Amerena

-Key opinion leader /NCI, ext experience in AUS & USA

•  Global Phase II – IV clinical trials in cardiovascular disease, as well as registries, in-house research

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Basic Model A team of 2 has become a team of 15

HOW DID THIS EXPANSION OCCUR? •  Separation of clinical and administrative responsibilities •  As our department has grown, the basic model has stayed the same

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PRIMARY  STUDY  NURSES  Focus  on  recruitment  and  ‘hands  on’    

study  co-­‐ordina>on

ADMINISTRATIVE  NURSES  Focus  on  administra>ve  study  du>es  e.g..  

ethics/finance/reg/hosp  &  HR    

Underlying Philosophy •  Different people like different things & have different strengths & weaknesses •  Optimisation of these attributes within the dept. •  Facilitate expertise & efficiency through experience •  Deliberate part-time strategy to minimise liability •  Create a workable structure for future staff •  To set a benchmark for dept. standards

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Department  Structure  -­‐  Need  For  Flexibility While the basic model has stayed the same, changes in

our research team structure have occurred over time

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Primary  Study  Nurse  -­‐  Research  Manager  backup

Two  team  approach

Primary  nurse/  backup  nurse

Current Structure Primary Study Nurse/ Backup ROLE -6 PT RNs & casual Research Nurse Specialist x 2 PT RNs -Clinical & Administrative Research Manager position split -Daily Operations Manager -Senior Advisory Role

Administrative assistant x1 - PT plus casual Medical -PI, Research fellow FT, Sub-Is

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How & Why This Model Works For Us •  Primary Nurse empowered, take ownership & ‘drive’

Backup nurse trained but takes a secondary role •  Each nurse - mix of primary and back up studies •  Each nurse – PORTFOLIOS •  All staff work on same diary - all work Wednesday •  Flexible approach- ↑ recruitment = ↑ staff (b/c of part-time strategy able to ↑ staff ) •  Efficiency created through experience

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•  Nurses benefit from working with different team members

•  Always someone in the dept. to respond to queries •  Monthly meetings - staff feedback, education •  Nurses encouraged to make full use of admin help •  Nurses not interrupted by admin / hospital needs •  NB – Clinical nurses- exposed to admin role but not

pressurised

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How & Why This Model Works For Us

Systems in place to support structure & maximise efficiencies •  Numerous Templates and Tracking sheets •  Own system for Regulatory folders with index •  Standardised pt. folders with tabs – medical Hx crucial docs •  Source data worksheets & guidelines for completing •  Unblinding folder & SAE reporting folder •  ‘’PI’’ maintains a password folder •  SOPS & Unit work instructions folder •  Hospital involvement in NHMRC pilots, RGO booklet

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How & Why This Model Works For Us

Keeping Track •  Use of described systems •  RM CC’d on significant correspondence •  Staff present study/recruitment at monthly meetings •  Assess w/loads & identify study and training needs •  Expectations clear for study activities & timelines •  Nurse PORTFOLIOS –measureable outcomes •  Involved PI / NC - who asks too many questions!

     

 

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•  Regular & Open Communication with Open door policy - let staff verbalise needs and when ready to expand •  Support staff in practice – OK to ‘push back’ •  Performance RV at 3 mths & annually with objectives •  Consider the implications of what we do, & remain mindful

of the skill-set within dept. •  Loyalty & accountable staff - >75rs experience •  Culture of Trust, Enthusiasm, Progression  

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Keeping Track

Building & Training A Team

•  Begins with recruiting the right people •  Employing wrong person/inability to retain right

person - impact on resources •  Consider needs specific to unit –

- RNs Div 1, Post grad CV or Diabetes •  Our system - predominantly part-time •  MUST be able to work in team

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Challenges in the public system ….. •  Wage & contract length determined by hospital •  Attraction to the role hindered by uncertainty •  Speed of recruitment depends on administrators •  Space - where to put someone once approved •  Institutional demands / regulations unrelated to

research

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Building & Training A Team

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•  Welcome, support &educate but don’t bombard •  Provide rationale, repeat, relate to GCP in practice Initially, Principles of GCP more important than detail •  Establish trust & reassure ‘not trying to kill anyone! •  Hospital & Research orientation folders & checklists •  External– FTF GCP 6 mths, ARCS, SPONSOR •  Therapeutic area as needed •  IATA training •  Flexible ‘life-work balance’ •  Culture –special achievements, birthday club, footy tips

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Building & Training A Team

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What We All Know… •  FEASIBILITY – target population/resources •  HREC - avoid delays •  BUDGET – self-funding, need to cover costs •  STUDY START-UP – parallel with HREC •  RECRUITMENT – ready to screen post SIV, select

well, good PICF, welcome, respect •  Differences b/w public & private in sourcing

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SITE SURVIVAL – RETURN BUSINESS - MEET KPIs

 Micro level it is important for site sustainability  Macro level it is important for clinical research in Australia

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What We All Know…

Challenges •  FEASIBILITY- limited information - 24-hour timeline –

104 questions!! •  HREC - trickle effect of essential documents

- impact of ‘streamlined system’ •  BUDGET – line items, complex, negotiating •  STUDY START-UP – sponsor delays, impact

resources, opportunity cost •  RECRUITMENT – unforeseen = high screen failure

rate, reduced timelines

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•  EXTERNAL VENDORS – so many – advance warning!

•  TRAINING – On-line study specific; eCRF, IWRS, GCP, logs logs….

•  Electronic Devices – ePRO – time consuming……..incompatibility issues

•  Access and passwords…..++++

Challenges

Payments - Time Lag – Study Visits – Monitoring - Payment (Third Party Processing Payments)

Site Administration Costs – Chase Late Payments/Incorrect Invoices Etc.

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Challenges

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Challenges Budgets & Payments

The Public System ….. •  Department self funded, but in a system where most

depts are not - ‘What’s the rush’’ •  Can’t always see what’s in the bank •  Whose money is it anyway? Control over accounts? •  Timing of invoice generation, bill payments, recruitment

all depend on actions of another person / dept

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Challenges

When Reviewing Budget - Impact Of… •  prohibited meds •  footnote in the flow chart •  Impact of one little asterix •  ‘’Protocol not quite finalised’’ •  Lab manual •  Safety – SUSARS, SAE reporting, Endpoints •  Pre-screening •  Taxi fares aint what they used to be

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Challenges

Budgets & Payments

Considerations for all sites •  Fair budget •  Frequent & Reasonable payment intervals •  Appropriate funding for all costs incurred

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The Way Forward……

WORK SMART…... •  Formalise Site/Sponsor Relationships •  Corporate memory – Sponsor/CRO •  Central registry of sites •  Review Site metrics –

www.emeritusresearch.com

IMPLEMENT - SiteDocsPortal ,eArchive EMBRACE- Transcelerate CREATE- a central registry of sites CONSIDER- social media, GP collaboration FOSTER – Sponsor relationships

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The Way Forward……

•  Common theme - need to manage resources effectively •  Ongoing critical appraisal of our practices

•  We must be flexible, change with the times, & have an attitude that promotes ongoing improvement to remain competitive

•  Patient remains number one priority •  Expect the unexpected ………………… This happened to us!

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The Way Forward……

What Is The Right Formula?

60 MILLION DOLLAR QUESTION 46

Discussion How Do Sites Deal With……….. •  Challenges •  Peaks and Troughs •  Surges and Plateaus •  Start and Stop •  Annual Leave/Sick Leave

Discussion - What do you think? •  How do you know that someone has enough work

or not enough? •  How do you project out resource availability? •  At what point is a trial considered ‘go’ (i.e. definitely

going ahead that you would allocate work? •  Do you have a system for keeping on top of

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•  How do you deal with unforeseen issues that have a huge impact (i.e. over recruiting, backlog of data entry, etc.)?

•  How do you know who is looking after which trials/back ups, dealing with leave?

•  Issues from the Audience?

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Discussion - What do you think?