- On this site
- Across the Global Health Network
-
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
-
19
Funding proposal
-
7
Identify source of funding
-
2
What is the intervention?
-
25
Register Clinical Trial
-
21
Secure Funding
-
16
Develop Trial Management System
-
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
|