A step by step approach for a intervention in clinical trials unit

1. SBS (Step by Step ) in Clinical Research Unit “From Idea to Publication” Version 1.0 09APRIL2013
Reproduction et utilisation interdite sans autorisation de l’auteur
2013GDepresseux©
Idea development Strengths Weakness To do
Objective(s) definition: Expert’s network / Translational research
integration / Partners / disease-specific state of the art knowledge /
Brainstorming / Hypotheses
Justification: Literature / Ethic / Fewer patients exposed / Avoid rejecting a
treatment for futility / Scientific / Treatment / Dose
Epidemiologic model: Access to Statistician / Literature / Blinding / Interim
analysis / Early Adaptive Design / Randomisation / Simulation report
Inclusion / exclusion criteria: Bias / Power / Recruitment / Retention
Recruitment: capacity to reach the number of patients needed
Indicators: Significant / Measurable / Realizable
Biological markers: correlated /capable of a net effect of the intervention
First drafts: First reviewers (disease specific experts / statistician)
Follow up: avoid early termination / major bottle necks / risks assess.
Partners: Objectives precision / Discussions / Authorship / DSMB / Financial &
confidentiality /Agreement / Conflict of interest / Feasibility / Drug supply
Final version 1.0
Case report form: paper / Web application
Informed patient consent form: Legal dispositions
Build the master file: Essential documents
Regulatory: Legal procedures / ICH-GCP / Internal procedures / Assistance
desk / Models / Risk based rules
Regulatory applications: Ethical committee / Competent authorities /
Internal / legal / National / European / Agreement / Insurance
Process installation Strengths Weakness To do
Timetable: Steps / Term / Simulation / Risks assessment
Patient accompaniment: Link person / Education / Quality of care
Study nurse: integration in the SOC
Appointments: Step by step patient’s progression
Medical: Flowchart / Physician exam / Medical file / SOC / Report / Time
Medico techniques: Imaging / Bio bank / Lab / Specific tools / Formation
Drug supply: In house Pharmacy / Pharma industry / Regulatory / Training
Coordination: Stakeholders / helpdesk / communication
Indicators: Pick up from the protocol
CRF: Training / Source documents /
Encoding: Real time / Queries / Corrective actions / Filters / Reliability
Database: DBC / Corrective actions / Data validation / Migration / Freezing
/ Protection / Sharing / Traceability / Statistician software
Regulatory continuum: Amendment / Annual reports / Master file /
Data analysis: Congruence with data base / Statistician
Descriptive stat: Patient’s recruitment / Retention
Biostatistics: Interim / Final analysis / Stat models / Interim analysis /
Conclusions / Report / Graphs
Data reporting: Coordination DBC-DAC-DSMB / End of protocol
Archives: Local and legal regulation
Quality of data Strengths Weakness To do
Supervision: Medical / Para medical / Functional / Relational
Study file: Essential documents / Amendments / Log sheets
Tools: t° log / quality indicators / calibration
SOP: Evaluation / Update / communication

2. SBS (Step by Step ) in Clinical Research Unit “From Idea to Publication” Version 1.0 09APRIL2013
Reproduction et utilisation interdite sans autorisation de l’auteur
2013GDepresseux©
Safety: Physician / Sponsor / DSMB / Risks assessment
Physician: time / medical file continuum / training ICH-GCP
Monitoring (QC): agenda / centralized / on site / risk / independent /
pharma / medico technic dpt
Audit independent (QA): SOP / Quality system / CR Unit evaluation.
Quality accreditation: involvement of the top management
Publication Strengths Weakness To do
Mentoring: Choice of journal /Sharing experiences / Data club
Reviewers: Peer review process / internal / external
Publication policy: clinicaltrial.gov
Notoriety: Diffusion internal & external / Mobility / Updated CV
Valorisation: Spin off / Local integration / Protection
Partners: Coordination / Objectives precision / Authorship / DSMB
Support: Finance Strengths Weakness To do
Structural and conjectural resources / National /European / Public and
private / Grant and agreements / Drug supply / Marginal / Indirect
Info desk
Notoriety opens gates & attract partners
Administrative Support: Accounts / Agreements / Invoicing / Regular
reports / Frequentation reports
Support: Management Strengths Weakness To do
Multi Skills: Scientist, Physician and Manager
Dual responsibility: Sponsor and Investigator
Human management: Skills / Recruitment / Outsourcing / Training /
Function / Evaluation / Duties clarification
Atmosphere management: Membership / Wellness / Stress management /
Acknowledgement / Implication / Motivation / Self accomplishment
Business management: Scientific or medical knowledge and tools /
Administrative and logistic tools / Table of duties indicators
Quality spirit: Scientific rigor / SOP / Hierarchic example / Culture
Quantity: Recruitment & retention / Data entry / Timetable
Network: Opportunities for little units / Share tools & Experience
Trial coordination
Keep continuum and lessons /
Continuity: Sustainability of the organization / Strengths /
weakness / Competitiveness
Support: Communication Strengths Weakness To do
Communication: SOP / Participation / Implication
Federation: Keep the team on the target / objectives / Duties clarification
Regular brainstorming / network / SOP / corrective actions
Mailing / Meetings / External and internal actors / Partners /
Health authorities / IT system
PI involvement: Local assessment / Retention
Newsletters: FAQs / Frequentation / Caveat / Reminders
Support: Equipment Strengths Weakness To do
Workspace: Access / Cleaning / Security
Material purchases: Best quality / price / agenda
IT: network communication / helps manager & coordination / Core Business /
Archives
Centralisation: Tools / Equipment / Services

3. SBS (Step by Step ) in Clinical Research Unit “From Idea to Publication” Version 1.0 09APRIL2013
Reproduction et utilisation interdite sans autorisation de l’auteur
2013GDepresseux©
Bio bank: Multi skills
Maintenance / Technical agreements / Regular supervision /
Reports and files / Insurance / Calibration
Innovative process Strengths Weakness To do
Actors: Identifying / Assessing / Launching / Convincing / Focus on opportunities
/ Proactive / Facing risks
Leader: look for consensus, not groupthink / welcome new ideas /
new behaviors / stretch & no stress / indicators only for motivation
CEO: Strategy / Facilitate / Approved / Keep the good behaviors
Strategy: Mining or Hunting / Push or Pull
Atmosphere: combine discipline and efficiency / reactivity
and agility / Values / Autonomy
Structure: big gives more legitimacy more research
capacity but difficulties to change
Open innovation: Local regulatory and policy context /
Network, Collaboration, Clusters, Alumni,
Professional associations
Academic freedom: what to share and with who / negotiate
ex ante and share ex post / property rights
Networking and mobility: notoriety attract partners
Have something to be courted
Objectives (Clinical Research) Strengths Weakness To do
Health improvement: New findings / New treatments
Professional skills: Notoriety / Medical / Para medic / Medico-technic
Professional implication: Deontology / Ethic / Carrier / Achievement
Academic: Mentoring / Teaching / Research / Services
Training: Long term process to the master work
Fertilisation: nourishing the ground of research / Useful behaviours / plus
value
Public authorities: Health / Economy / Employment
Objectives (Manager) Strengths Weakness To do
Quality: Rigour / SOP
Quantity: Recruitment & retention / Data entry / Timetable
Atmospheres: HR / Skills / Training / Motivation / Self accomplishment /
Membership
Finance: Structural / Conjectural / Marginal / Indirect
Continuity: Sustainability of the organisation / Strengths / Competitiveness
Ground of research Strengths Weakness To do
Education / Scientific opportunities / Stimulating environment
Attractive career / Disease-related network / Initiatives support /
Excellence examples / Management & Recruitment / Mentoring /
Innovative organisation
Inside care providers: Study nurse / Pharmacy / Laboratory / Medico
technic / Ambulatory unit / Physicians
Outside care providers: General practitioner / network
Stakeholders : IMP owner / PI & partners / Coordinator / Administrative &
technical support / Translational research
Authorities: Institution & National authorities / Ethics committee /
Training: ICH-GCP