Draft Proposal – Clinical Trials Programme

It is mandatory to follow the Draft Proposal Preparation Instructions (DFG form 17.03). 
Do not exceed a maximum of 8 pages including headings 1 to 15.

1	Trial Synopsis

Applicant(s) /
coordinating 
investigator(s)
		
Statistician		
Co-applicant(s)		
Title of trial (English)		
Title of trial
(German)		
Medical condition		
Hypothesis		
Participants / study population	
Key inclusion criteria:
Key exclusion criteria:
	
Trial type	
Interventional trial:  [   ]

Observational trial: [  ]

If you have chosen an observational trial, please justify your decision briefly: 

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Key elements: 
	
Treatments / procedures 	
Experimental intervention:
Control intervention:
Follow-up per patient:
Duration of intervention per patient: 
	
Endpoint(s) 	
Primary endpoint:
Secondary endpoint(s):
Assessment of safety:
	
Trial duration	
First patient in to last patient out (months): 
Duration of the entire trial (months):
Recruitment period (months):
	
Statistical analysis	
Statistical methods used to compare groups for primary and secondary outcomes:
Methods for additional analyses, such as subgroup analyses and adjusted analyses:
	
Sample size	
To be assessed for eligibility:                       (n =   )
To be assigned to the trial, i.e. recruited:    (n =   )
To be analysed:                                              (n =   )
	
Participating sites 	
No. of cities to be involved:  
No. of centres to be involved: 
Names of cities and centres: 
	
Previous DFG project number		

Submission of proposal elsewhere

2	Proposal History / Project History

[Text]

3	Trial Design

[Diagram]

4	Medical Problem and Relevance

[Text]

5	Patient Involvement

[Text]

6	Evidence

6.1	Search Strategy

[Text]

6.2	Discussion of Evidence

[Text]

7	Justification of Design Aspects

7.1	Observational Trial
(if applicable)

[Text]

7.2	Control(s) / Comparator(s)

[Text]

7.3	Participants / Study Population

[Text]

7.4	Treatments / Procedures

[Text]

7.5	Outcome Measures

[Text]

7.6	Methods Against Bias

[Text]

7.7	Proposed Sample Size / Power Calculations

[Text]

7.8	Feasibility of Recruitment / Access to Study Population

[Text]

8	Statistical Analysis

[Text]

9	Ethical Considerations

[Text]

10	Budget Summary

Item	Amount for entire trial (€)	Amount for current funding period (€)	
Clinical project management			
Project management			
Case payments			
Data management			
Biostatistics			
Quality assurance			
Travel			
Materials			
Trial drugs			
Fees and insurance			
Other			
Total (€)			

11	Commercial Interest
Is the trial drug or the therapeutic, diagnostic or prognostic procedure that is the object of this trial under patent protection?

[   ] Yes, until [date]                                                        [   ] No 
	If yes, please specify.	

12	Co-Financing of the Trial by a Company or Other Third Party

[   ] Yes			                                              [   ] No 
	If yes, please specify.	

13	Researchers in Germany and abroad with whom you have agreed to cooperate on this project

[Text]

14	Researchers with whom you have collaborated scientifically within the past three years

[Text]

15	List of project- and subject-related publications
This list of publications is used for general reference. This list should only contain the works you cited. Please include DOI/URL if available. The font used for the publication list should not be less than Arial 9 point.
A maximum of ten of your own publications that are most relevant to the project can be highlighted in bold or some other way. Even if there are several applicants, the maximum of ten highlighted works may not be exceeded.

[Text]