Proposal Template – Clinical Trials Programme

It is mandatory to follow the Proposal Preparation Instructions (DFG form 17.02).
Do not exceed the maximum of 25 pages including headings 1 to 20.
Sections 1-15 must not exceed 19 pages in total and for sections 16 to 20 up to 6 pages.

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	
Feasibility study (interventional design only):   

Interventional trial:   

Observational trial:   

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

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Key elements:
	
Is the approval of a competent federal authority necessary	
No     

Yes   

Give reasons for your answer and briefly explain which federal authority’s approval is to be obtained.
	
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

[schematic Diagram or table]

4	Frequency and Scope of Trial Visits

[Table]

5	Medical Problem and Relevance

[Text]

6	Patient Involvement

[Text]

7	Evidence

7.1	Search strategy and search results

[Text]

7.2	Discussion of evidence 

[Text]

8	Justification of Design Aspects

8.1	Feasibility study
	(if applicable)

[Text]

8.2	Observational trials
	(if applicable)

[Text]

8.3	Control(s) / comparator(s)

[Text]

8.4	Participants / study population

[Text]

8.5	Treatments / procedures 

[Text]

8.6	Additional treatments

[Text]

8.7	Outcome measures 

[Text]

8.8	Methods against bias

[Text]

8.9	Proposed sample size / power calculations

[Text]

8.9.1	Compliance / rate of loss to follow-up

[Text]

8.10	Feasibility of recruitment / access to study population

[Text]

8.10.1	Recruitment table

Full name of Investigator 	City and name of institution 	No. of patients with relevant condition seen in the last 12 months fulfilling inclusion/exclusion criteria	Approx. no. of these patients who would agree to participate in the trial per year	Approx. no. of these patients who would be recruited during the entire trial	

					
Sum of all patients expected to be recruited for the entire trial		

For renewal proposals use the table below:
Full name of Investigator 	City and name of institution 	No. of patients already included 	Approx. no. of patients included per months in this site	Expected no. of patients to be recruited until end of trial	

					
	Total:		Total:		

8.11	International trials
	(if applicable)

[Text]

9	Statistical Analysis

[Text]

10	Ethical Considerations

[Text]

11	Quality Assurance and Safety

11.1	Monitoring and data reviewing 

[Text]

11.2	Intensity and Amount of Monitoring Required for Your Trial 

Prediction for the intensity and amount of monitoring required for your trial	
No. of patients assigned to the trial		
No. of recruiting centres 		
Average no. of patients per trial site		
Average no. of monitoring visits per trial site (site selection and close-out visits are excluded) 		
No. of doctor’s visits per patient during the course of the whole trial		
Expected number of AEs and SAEs	Please comment briefly:	
Complexity of inclusion and exclusion criteria	Please comment briefly:	

11.3	Involvement of independent experts

Independent experts	
#	Name	Name of institution and city	
1			
2			
3			

11.3.1	Role of independent experts

[Text]

12	Trial Infrastructure

[Text]

13	Trial Time Flow

[Diagram]

14	Strategies for Data Handling and the Dissemination of Results

[Text]

15	Project- and Subject-Related List of 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]

Sections 16-20 must not exceed 6 pages in total.

16	List of Other Trial Participants

Name of trial sponsor	
	
Supporting facilities (central laboratories, pharmacies, etc.)	
Name	Name of institution and city	Responsibility/role	
			
Other participating groups/bodies	
Name	Name of institution and city	Responsibility/role	
			
Review of trial protocol 	
Name	Name of institution and city	

17	Cooperation with Other Researchers

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

[Text]

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

[Text]

18	Commercial Interest 

[Text]

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. 

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

 Yes				 No

If yes, please specify. 

20	Financial Details of the Trial

Amount for entire trial (€)		
Entire duration of the trial (months)		
		
Amount for the current funding period (€)		
Duration of the current funding period (months)		

20.1	Budget summary (for the current funding period)
(Fill in the relevant white fields, only. You may delete headings that are not applicable and the examples in italic font.)

20.2.1. Funding for staff
	DFG staff category1 (e.g. postdoctoral researcher)	
Amount	Percentage of full-time position	Duration             (in months)	costs €	
a. Clinical Project Management	
e.g. clinical project manager						
e.g. study nurse						
b. Project Management	
e.g. project manager						
c. Data Management	
e.g. data manager						
d. Biometry	
e.g. biometrician						
e. Monitoring/ Quality Assurance	
e.g. monitor						
f. Pharmacovigilance	
e.g. regulatory affair manager						
g. Other Staff	
…						
Total costs funding for staff		
20.2.2. Direct project costs	
Specification	costs €	
a. Equipment up to €10,000 and consumables	
			
Total costs for a.		
b. Travel expenses	
e.g. for scientific meetings			
e.g. travel expenses for monitoring			
Total costs for b.		
c. Visiting researchers 

Total costs for c.		
d. Other costs:

	
e.g. third-party contract	e.g. contract KKS		
e.g. case payments			
e.g. fees			
e.g. trial medication			
…			
Total costs d.		
e. Project-related publication expenses	
			
Total costs e.			
20.2.3. Instrumentation	
Specification	costs €
	
e.g. Equipment exceeding €10,000 			
e.g. Major instrumentation exceeding €50,000 			
20.2.4. Replacements	
Specification		costs €	
			
20.2.5 Temporary substitutes
 for clinicians	Specification	
Percentage of full-time position	Duration             (in months)	costs €	
					
20.2.6. Mercator Fellows	
Specification	costs €	
			
20.2.7 Project-specific workshops	
Specification	costs €	
			
20.2.8. Public relations 	
Specification	costs €	
			
Total amount for current funding period €		

20.2	Detailed budget plan (for the current funding period)

20.2.1	Funding for staff

a.	Clinical Project Management

[Text]

b.	Project Management

[Text]

c.	Data Management

[Text]

d.	Biometry

[Text]

e.	Monitoring/Quality Assurance

[Text]

f.	Pharmacovigilance

[Text]

g.	Other Staff

[Text]

20.2.2	Funding for direct project costs

a.	Equipment up to €10,000, software and consumables

[Text]

b.	Travel expenses

[Text]

c.	Visiting researchers (excluding Mercator Fellows)

[Text]

d.	Other costs

[Text]

e.	Project-related publication expenses

[Text]

20.2.3	Instrumentation

a.	Equipment exceeding €10,000

[Text]

b.	Major instrumentation exceeding €50,000 

[Text]
S
20.2.4	Replacements

[Text]

20.2.5	Temporary substitutes for clinicians

[Text]

20.2.6	Mercator Fellows

[Text]

20.2.7	Project-specific workshops

[Text]

20.2.8	Public relations

[Text]

20.3	Additional funding

[Text]

20.4	Contribution by the institution regarding staff and consumables (Core Support)

[Text]

21	Considerations on aspects of ecological sustainability in the planning and implementation of the project

[Text]