ANSM - Agence nationale de sécurité du médicament et des produits de santé

	Form 5

	
Clinical investigation involving a medical device or an in vitro
diagnostic medical device
Vigilance report : Initial report
		
Articles L. 1123-10 and R. 1123-39 to 1123- 44, R. 1123-48 and R. 1123-54 of the public health code

Suspected unexpected serious adverse effect		
Serious adverse event possibly related to the procedure for implementation of the  medical device 		
To be sent	
By email (preferred) to: 	EC.DM-COS@ansm.sante.fr
(in the subject line, type in “VIGILANCE” and the number assigned by the ANSM (French Health Product Safety Agency) during registration of the application for marketing authorization and opinion)	
By mail to:
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Direction des dispositifs médicaux thérapeutiques et des cosmétiques
Essais cliniques
143-147 Boulevard Anatole France
93285 Saint-Denis cedex
	
By fax to:	33 01.55.87.37.17
	(Send to the attention of ANSM/DMTCOS)	

This section for ANSM only

Date received  of the report :	     /     /     

Registration number: 	     /     /     /ei      

Clinical investigation identification 
Clinical investigation registration number from the ANSM:        	
Code number of the Clinical investigation assigned by the sponsor, version and date:      
Full title of the biomedical research:      	

Code number identifying the Clinical investigation participant:      

Patient initials:	Surname initial:        	First name initial:        

Gender:   F:        M:   Date of birth:      /     /      and/or Age:      years  
Medical device used: 
Common device name (for example: arterial stent):      
Trade name (if CE mark):      
Model:      	Version (including software):      
Serial no.:      	Batch no.:      
Reason for which the device was used in this patient:      
How the device was used:      

Starting date of this device utilization : 	     /     /     

Termination date of this device utilization : 	     /     /     
Was there “unblinding”? yes  	no  	N/A   
If yes, results:      
Other treatments:
Concomitant drug therapy and non-drug treatments (dosage, date treatment began, etc.):
______________________________________________________________________________

Information about the suspicion of serious adverse effects or events:
Complete description including signs and/or symptoms, organ affected, severity, and the criteria that qualifies the effect as serious; if necessary, explain the diagnosis:
     
Description of the adverse effect or event: 
Date of 1st onset      /     /     
End date      /     /      or duration (specify time period):      
What were the consequences when  the device was suspended and, if applicable, when the device was reintroduced:
     
Place of occurrence (research centre, hospital, day hospital, home, nursing home, etc.)
     

Follow-up will be mentioned (information related to recovery and possible after-effects (sequels), additional tests and if necessary, specific treatments required and their results).
Death  		give the cause:      
Any additional information about a possible cause/effect relationship, especially including any information resulting from an eventual autopsy or other post-mortem tests (including the medical examiner report) when they are available: 
     

Important details factors that can help in the evaluation of the case :  related pathologies (can have a causal relationship with the serious adverse event - SAE), Medical and family histories; results obtained through special investigations:
     
______________________________________________________________________________
Possible Cause/Effect Relationship

Imputability estimate 
 
•	by the sponsor: 
- to MD:	          certain	                    likely		       possible	 	
                            not likely	
•	to the procedure for implementation of the MD:
		certain: 		likely: 	possible:  	not likely: 

•	by the investigator (only in the case of a discrepancy between the sponsor and investigator): 
- to MD:	certain		likely		possible	 	
                 not likely	
•	to the procedure for implementation of  the DM:
		certain: 		likely: 	possible:  	not likely: 

Important comments:

     	

Identification of the reporter
-	Name of person to be contacted:     
-	Address:      
-	Telephone number:      

Administrative and sponsor information

Date of report by the sponsor:      /     /     
Origin of the effect/event:
a)	biomedical investigation :                              
b)	scientific literature (provide a copy): 
c)	spontaneous notifications :              
d)	other health/registry authority: 
Date on which the sponsor first became aware of the adverse event: 
     /     /     
Country in which the event occurred:      
Sponsor name:      
Sponsor address:
     	
Person delegated by the sponsor to submit the report 
-	Name of the person :     
-	Address:      
-	Telephone number:      
-	Fax number:      
Case ID number assigned by the sponsor:      	
Attach a copy of the Serious Adverse Event (SAE) report form filled out by the investigator.
Attach a copy of the hospital report if available 

Date:      /     /     		Sponsor signature:      

Name:      		Title :