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

	Form 6

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

Date of initial report to the ANSM: //	

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)	

Par courrier à :               
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

Par fax : 	01.55.87.37.17
	(Spécifier à l’attention de l’ANSM/DMTCOS)	

This section for ANSM only

Date additional report was received:	//

Registration number:                                         ///ei 

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

	
Date of the additional information report :                      //	

Code number identifying the investigation participant:             

Patient Initials : Surname initial:   First name initial:   
Gender:   F:        M: 	Birthday:	// and/or Age: years  

Follow-up of the previously reported serious adverse effect/event (the possible initiated treatments and the results will be listed):

Additional information obtained since the initial report:

______________________________________________________________________________
Do additional data change the assessment of the effect’s or event’s imputability to the device being studied? yes:        no:        
If yes, explain:

Comments:  

	

Attach a copy of the Serious Adverse Event (SAE) report form filled out by the investigator.
Attach a copy of the hospital report if necessary 

Date: //		Sponsor signature: 

Name: 		Quality: