Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
Agreements with OHRA Minimize

40. What items are necessary according to the EU GTP to have in agreements with OHRA or general conditions?

 

o

Costprice of tissues

o

Who to report SAE and/or SAR to = right answer

o

Who is the Responsible Person

o

Who arranges the transport of the tissues to the transplanting surgeon

 

41. Is it necessary according to the EU directive 2004/23 and both annexes to have agreements with third parties e.g. on storage conditions or transport?

 

o

Yes, because responsibilities have to be established because of the costs

o

Yes, because responsibilities have to be established in order to ensure the safety and quality of the tissues

o

Depends, every TE can decide this for itself

o

No, this is not at all necessary.

 

42. How long should donor data be recorded and kept on file?

 

o

15 years

o

Forever

o

30 years after clinical use

o

30 years

 

 

43. Is it permitted for the clients to send the tissues on to other parties?

 

o

No, this should be documented in the agreement or general conditions

o

Yes, if the client pays for the tissue, it is his property and the client can do with it as he thinks right.

o

Under certain circumstances if the client has permission from the contractor to do so.

o

Yes, if there is a medical necessity.

 

 

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