Form Progress report
If the research has ended in the Netherlands, please fill in the form "Notification end of study"; In that case do not use the form "Progress report". Questions? Call Afdeling Toetsing Onderzoek (+31 88 7556376) or send an email to info@metcutrecht.nl.
1.	Sponsor of the trial/study: …………………………………………….…
Company/organisation: ……………………………………..……….
Department: ………………………………………………………….
Address: ………………………………………………………….…
ZIP code, city: ……………………………………………….
Name contact person: …………………………………………
Email contact person: ……………………………………
Telephone contact person: ………………………………………

2.	Study title: ………………………………………………

3.	Dossier number ToetsingOnline: NL…………………

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

5.	How many study subjects have been included so far?
	Netherlands: ………………
	International: ……………….

6.	How many study subjects should have been included according to planning?
Netherlands: ………………
	International: ……………….

7.	What is the total number of study subjects what should have been included according to protocol?
Netherlands: ………………
International: ……………….

8.	In case of multicenter research:

  not applicable

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

9.	How many study subjects in the Netherlands have completed the study according to protocol?
	……………………………

10.	How many study subjects stopped prematurely with the study?
	……………………………….
11.	How many study subjects stopped prematurely with the study for the following reasons?

  not applicable
  lack of efficacy: ……
  adverse effects: ……
  at own request: ……
  other, namely: ……

12.	Were there serious adverse event/side effects? 
  yes
  no

If yes, did you report these to the CCMO?
  yes
  no, please indicate why not?
………………………………………………………………………………
……………………………………………………………………………..
13.	Are (were) there unexpected problems that prevent progress of the study?  
  yes
  no
If yes, If yes, what kind of problems?
………………………………………………………………….
………………………………………………………………………

14.	Is there a Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee appointed? 
  yes
  no

If yes, did the committee give an advice?
  yes
  no

If yes, did the sponsor of the study follow this advice? 
  yes
  no, for what reason: …………………………………………….

15.	Were there amendments on the research protocol? 
  yes
  no

If yes, how many? ………………………………
Were these reviewed by the CCMO? 
  yes
  no

16.	What is the expected end date of the study worldwide? ……………………….

Name (contact person sponsor):………………………………………….

Signature:………………………….				Date:………………