• 26
    Regulatory approvals submission
  • 29
    Submit to Clinical Trial Authority Review
  • 28
    Submit to Ethics Review
  • 27
    Submit to Institutional Review Board(s)
  • 11
    Finalise Protocol. Send to Sponsor
  • 3
    Characterise study and identify regulations
  • 18
    Set budget
  • 17
    Identify insurance required
  • 20
    Peer review - may be part of funding proposal. If not, peer review may be sought for further guidance and additional good practice
  • 14
    Risk assessment
  • 39
    Study Initiation visit – check all procedures in place
  • 4
    Develop Study Protocol
  • 7
    Identify source of funding
  • 19
    Funding proposal
  • 2
    What is the intervention?
  • 25
    Register Clinical Trial
  • 16
    Develop Trial Management System
  • 21
    Secure Funding
  • 24
    Contracts agreed
  • 40
    Information Sessions for study staff
  • 22
    Organise appropriate legal cover
  • 41
    Begin recruitment
  • 31
    Set up oversight committees stated in QA plan
  • 15
    Develop Quality Assurance Plan
  • 37
    Complete training in SOPS and GCP
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Trial conception
Design phase
Agreements phase
Approval phase
Site(s) preparation phase
Oversight
Peer review - may be part of funding proposal. If not, peer review may be sought for further guidance and additional good practice20
Submit to Institutional Review Board(s)27
Submit to Ethics Review28
Submit to Clinical Trial Authority Review29
Set up oversight committees stated in QA plan31
DSMB?32
Steering Committee?33
End Point Review?34
Governance
Characterise study and identify regulations3
Identify source of funding7
Identify sponsor6
Set budget18
Identify insurance required17
Funding proposal19
Organise appropriate legal cover22
Secure Funding21
Sponsor Approval of Protocol23
Contracts agreed24
Register Clinical Trial25
Regulatory approvals submission26
Assemble Essential Documents in Study Master File30
Study Initiation visit – check all procedures in place39
Operations
Study design5
Risk assessment14
Consider study population, sample size and trial statistics12
Consider data management requirements13
Develop Quality Assurance Plan15
Develop Trial Management System16
Set up Clinical Data Management System35
Finalise SOPS36
Complete training in SOPS and GCP37
Information Sessions for study staff40
Begin recruitment41
Protocol
Develop research question1
Develop Study Protocol4
Finalise Protocol. Send to Sponsor11
Intervention
What is the intervention?2
Intervention and Laboratory organisation, supply and logistics8
Develop Pharmacovigilance / Safety Reporting Plan9
Finalise intervention and laboratory requirements10
Are study supplies ready?38