Interim Report Template – Clinical Trials Programme

Applicants must follow the Interim Report Preparation Instructions (DFG form 17.04). 
www.dfg.de/formulare/17_04
Do not exceed a maximum of 5 pages for headings 1 to 3.

1	General Information

1.1	Applicant/Coordinating investigator

[Text]

1.2	Title of trial

[Text]

1.3	Type of trial

	Interventional trial:  	Observational trial:   

1.4	DFG project number of the proposal

[Text]

1.5	Report date

[Text]

1.6	Reporting period

[Text]

2	Status Report

2.1	Trial registration 

[Text]
 
2.2	Trial protocol publication

[Text]
 
2.3	Dates of competent authority approval

[Text]

2.4	Approval by the ethics committee 

[Text]

2.5	Trial time flow

[Diagram]

2.6	Number of patients to be recruited 

[Text]

2.7	First patient in (date)

[Text]

2.8	Total number of patients in/Percentage of patients in

[Text]
 
2.9	 Number of patients in follow-up

[Text]

2.10	Last patient in (date)

[Text]

2.11	 Last patient out (date)

[Text]

2.12	 Recruitment of patients

2.12.1	Recruitment graph 

[Graph]

2.12.2	Recruitment table 

[Table]

2.12.3	Recruitment problems 

[Text]

2.12.4	Improvement of patient recruitment

[Text]

2.12.5	 Conclusion

[Text]

3	Changes in Trial Design Aspects and Statistical Analysis

3.1	Control(s)/Comparator(s)

[Text]

3.2	Dose, mode and scheme of intervention

[Text]

3.3	Additional treatments

[Text]

3.4	Inclusion and exclusion criteria

[Text]

3.5	Determination of primary and secondary measures

[Text]

3.6	Methods against bias

[Text]

3.7	Proposed sample size/Power calculations

[Text]

3.8	Originality and quality of the study

[Text]

3.9	Statistical analysis

[Text]

4	Quality Assurance and Safety

4.1	Declaration by the DSMB 
•	Please provide a recent declaration by the Data and Safety Monitoring Board (DSMB) stating that no concerns exist regarding the continuation of the trial. Please attach this statement as an addendum to this report.