Form Notification end of study

If the research will not start in the Netherlands / has never started in the Netherlands, please fill in the form "Progress report". In that case do not use the form "Notification end of study".  
Questions? Call Afdeling Toetsing Onderzoek (+31 88 7556376) or send an email to metc@nedmec.nl. 

A1.	Sponsor of the trial/study: …………………………………………….…
Company/organisation: ……………………………………..……….
Departement: ………………………………………………………….
Address: ………………………………………………………….…
ZIP code, city: ……………………………………………….
Name contactperson: …………………………………………
Email contactperson: ……………………………………
Telephone contactperson: ………………………………………

A2.	Title study: ………………………………………………

A3.	Dossiernumber ToetsingOnline: NL…………………

A4.	Number  included subjects per approved participating centre in the Netherlands
Centre/number of subjects
…………………./……………….
…………………./……………….
…………………./……………….
…………………./……………….
…………………./……………….

A5.	On which date was the first study subject included in the study?
……………………..

A6.	On which date did the study end in the Netherlands?
 ……………………

A7.	Did the study end worldwide? 
  yes 
  no
  na, study was only carried out in the Netherlands

A7a. If yes, on which date?: ……………..
A7b. If yes, how many subjects have been included worldwide?  ………………….

A8.	Was the study prematurely terminated?  
  yes
  no

A8a. If yes, give reason(s)? 
  safety
  lack of efficacy
  not enough subjects
  other, namely …………………………….

A8b. What was the justification of the early termination? ……………………..
………………………………………………………………………………………………..
………………………………………………………………………………………………..

A8c.  How many study subjects were still participating in the study when the study was prematurely terminated? ……………………………………………………………………………………………….
………………………………………………………………………………………………..
………………………………………………………………………………………………..

A8d. What procedure will be followed on how to inform and treat subjects who were still participating in the study at the time of early termination?
………………………………………………………………………………………………..
………………………………………………………………………………………………..
………………………..……………………………………………………………………..

A8e. What are the possible consequences for the processing of the study data?  ………………………………………………………………………………………………
………………………………………………………………………………………………..
………………………………………………………………………………………………..

Within one year after the end of the study a summary with results and conclusion of the study should be submitted to the reviewing committtee. This can be done  by using the button  "Make study results" in ToetsingOnline. Other publications about the study can also be uploaded in ToetsingOnline via the button “Make study results”.

Name (contactperson sponsor):………………………………………….

Signature:………………………….				Date:………………