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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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)30
Submit to Ethics Review31
Submit to Clinical Trial Authority Review32
Set up oversight committees stated in QA plan34
DSMB?37
Steering Committee?38
End Point Review?39
Governance
Characterise study and identify regulations3
Identify source of funding11
Identify sponsor12
Set budget15
Identify insurance required16
Funding proposal21
Organise appropriate legal cover22
Secure Funding25
Sponsor Approval of Protocol26
Contracts agreed27
Register Clinical Trial28
Regulatory approvals submission29
Assemble Essential Documents in Study Master File33
Study Initiation visit – check all procedures in place42
Operations
Study design8
Risk assessment9
Consider study population, sample size and trial statistics13
Consider data management requirements14
Develop Quality Assurance Plan17
Develop Trial Management System18
Set up Clinical Data Management System35
Finalise SOPS36
Complete training in SOPS and GCP40
Information Sessions for study staff43
Begin recruitment44
Protocol
Develop research question1
Develop Study Protocol7
Finalise Protocol. Send to Sponsor23
Intervention
What is the intervention?2
Intervention and Laboratory organisation, supply and logistics10
Develop Pharmacovigilance / Safety Reporting Plan19
Finalise intervention and laboratory requirements24
Are study supplies ready?41