Research Protocol Template

GeNext MedEd Foundation
Research Protocol Template
Document code: GMEF-RES-PROT-001  
Version: 1.0  
Status: Controlled academic template

Project identification
Project title:  
Research Connect ID:  
Protocol version/date:  
Principal / lead investigator:  
Responsible institution(s):  
Academic community / working group:  

1. Background and rationale
Summarise the problem, existing evidence, knowledge gap and why the project matters.

2. Research question and objectives
Primary question:  
Primary objective:  
Secondary objectives:  
Hypothesis, where relevant:  

3. Study design and setting
Design:  
Study setting/site(s):  
Population:  
Inclusion criteria:  
Exclusion criteria:  
Sampling / recruitment approach:  
Sample-size rationale:  

4. Variables and outcomes
Primary outcome(s):  
Secondary outcome(s):  
Exposure/intervention variables:  
Potential confounders:  
Definitions / data dictionary reference:  

5. Procedures and data flow
Source of data:  
Data collection method:  
Timeline:  
Site responsibilities:  
Quality checks:  

6. Analysis plan
Statistical / qualitative methods:  
Missing-data approach:  
Planned subgroup/sensitivity analyses:  
Methodology/statistics reviewer:  

7. Governance and ethics
IEC/IRB determination/approval required:  
Approval/reference/status:  
Consent framework:  
Trial/registry registration where applicable:  
Institutional permissions:  
Safety/adverse-event route where applicable:  

8. Privacy and data governance
Identifiable data involved:  
De-identification/pseudonymisation:  
Access roles:  
Storage system:  
Data-sharing agreement/reference:  
Retention/closure plan:  

9. Contributors, funding and conflicts
Investigator/collaborator roles:  
Funding/support:  
Conflicts/disclosures:  
Expected authorship/contribution approach:  

10. Outputs and dissemination
Planned abstract/presentation/manuscript/report:  
Target audience/journal where known:  
Archive plan:  

11. Version control
Material protocol amendments should receive a new version/date and follow the approvals required by the responsible institution and governance pathway.