- On this site
- Across the Global Health Network
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39
Study Initiation visit – check all procedures in place
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41
Begin recruitment
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4
Develop Study Protocol
Click on a step to view information on it.
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Trial conception
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Design phase
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Agreements phase
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Approval phase
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Site(s) preparation phase
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| Oversight |
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Peer review - may be part of funding proposal. If not, peer review may be sought for further guidance and additional good practice20
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Submit to Institutional Review Board(s)27
Submit to Ethics Review28
Submit to Clinical Trial Authority Review29
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Set up oversight committees stated in QA plan31
DSMB?32
Steering Committee?33
End Point Review?34
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| Governance |
Characterise study and identify regulations3
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Identify source of funding7
Identify sponsor6
Set budget18
Identify insurance required17
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Funding proposal19
Organise appropriate legal cover22
Secure Funding21
Sponsor Approval of Protocol23
Contracts agreed24
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Register Clinical Trial25
Regulatory approvals submission26
Assemble Essential Documents in Study Master File30
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Study Initiation visit – check all procedures in place39
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| Operations |
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Study design5
Risk assessment14
Consider study population, sample size and trial statistics12
Consider data management requirements13
Develop Quality Assurance Plan15
Develop Trial Management System16
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Set up Clinical Data Management System35
Finalise SOPS36
Complete training in SOPS and GCP37
Information Sessions for study staff40
Begin recruitment41
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| Protocol |
Develop research question1
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Develop Study Protocol4
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Finalise Protocol. Send to Sponsor11
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| Intervention |
What is the intervention?2
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Intervention and Laboratory organisation, supply and logistics8
Develop Pharmacovigilance / Safety Reporting Plan9
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Finalise intervention and laboratory requirements10
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Are study supplies ready?38
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