Draft Proposal – Clinical Trial	
1.	Trial Synopsis

Applicant/
Coordinating 
investigator		
Title of trial		
Research Field	☐ A – Difficult-to-treat infections
☐ B – Novel strategies for antimicrobial treatment
☐ C – Targeted strategies in organ failure
☐ D – Outcome Research
☐ Others	
Medical condition		
Objective(s)		
Intervention(s)	Experimental intervention/index test:
Control intervention/reference test:
Follow-up per patient:
Duration of intervention per patient:	
Key inclusion and exclusion criteria	Key inclusion criteria:
Key exclusion criteria:	
Outcome(s)	Primary efficacy endpoint:
Key secondary endpoint(s):
Assessment of safety:	
Study type / design	☐ interventional
☐ Drug (AMG)/Medical Device (MPG)  ☐ Medical / Nursing Act (Non-AMG/-MPG)
☐ non-Interventional
☐ observational      ☐ epidemiological      ☐ other   
Allocation
☐single-group   ☐controlled, non-randomized    ☐controlled-randomized   ☐other 
Masking
☐ open-label     ☐ single-blind       ☐ double-blind   ☐ other
Purpose
☐  Therapy              ☐ Prevention  ☐ Diagnostic               ☐ Prognostic 
☐ Supportive Care    ☐ Screening   ☐ Healthcare Research ☐ Health economics
☐ other: 
	
Statistical analysis	Efficacy/test accuracy:
Description of the primary efficacy/test accuracy analysis and population:
Safety:
Secondary endpoints:	
Sample size	To be assessed for eligibility: (n =           )
To be assigned to the trial:    (n =           )
To be analysed:                    (n =           )	
Trial duration	First patient in to last patient out (months): 
Duration of the entire trial (months):
Recruitment period (months):	
Participating centres	n =	

2.	The Medical Problem – need for a trial

3.	Justification of Design Aspects

3.1	Control(s)/Comparator(s)

3.2	Inclusion and exclusion criteria

3.3	Outcome measures 

3.4	Methods against bias

3.5	Proposed sample size/Power calculations

3.6	Feasibility of recruitment

4.	Statistical Analysis

5.	Ethical Considerations

6.	Trial Management

6.1	Key participants

#	Name	Affiliation	Responsibilty / Role	
1			Principal investigator	
2			Co-investigator	
3			Trial statistician	
4			Data Management	
5			Documentation / Study Nurse	

6.2	Time-schedule and milestones

6.3	Trial expertise (your own project-specific publications)

6.4	Supporting facilities

7.	Budget

7.1	Budget Summary 

Item	Total funding period (1 – 3 years / EUR)	
Clinical project management		
Project management		
Case payments		
Data management		
Biostatistics		
Quality assurance		
Materials		
Trial drugs		
Fees and insurance		
Other		
Total		

7.2	Co-financing of the trial (e.g. by a company)  (if applicable)

8.	Bibliography

Do not exceed the maximum of 6 pages at all.

Attachment:

Previous work of the applicant within the CSCC in the 1st funding period
•	Project, funding structure 
•	results, publications