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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
resource? 48
• 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?