Global Health Research
Step-by-step guidance for planning successful global health research projects. A comprehensive, interactive resource providing: eLearning, questions and answers, expert guidance, links and tools. Free, open access, and applicable to all health research settings. Enabling high quality health research, with extra support for clinical trials. Read more
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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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