ANNEX C.1: Ethics application form (template)

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Ethical application Form template to be submitted to Local Ethical Committee/Bodies, etc. and communicated to responsible partner.

Submitted at:

Title:

.......................................................................................................................................

Ethical application form status:
 Submitted
 Passed
 Re-submitted

Ethics Site Responsible

Name:

Function:

Address:

Tel.:

Fax:

E-Mail:

Description of the Pilot/Test/Study

.......................................................................................................................................

.......................................................................................................................................

.......................................................................................................................................

.......................................................................................................................................

Ethical Considerations/ Benefit and burden of the Pilot/Test/Study

.......................................................................................................................................

Number of participants: __N

Participation of participants who need special protection?

€       No

€       yes

€       healthy subjects

€       Underage

€       patients

€       people unable to give valid consent

€       emergency patients

€       patients who are in the process of dying

€       others: 

Multicenter study

Name of the other countries who take part in the study:

 

Duration:

 

Approval of the Local Research Ethics Committee  

      yes, please attach approval                            

      no

      pendent

Protocol: (short description)

 

Insurance: (short description)

……………………………………………………………………………..…………………………………………………………………………………………………..

 

 

Date:                                               

Name of the Ethics Site Responsible/ Signature:

 

 

                                                        

Will be filled in by the Ethics Secretary

 

The Ethics Secretary confirms that the application has been approved by the

NAME(S):  ....................................................................................

 

Date:   Signature: