Copyright for articles used in CER (Clinical Evaluation Report)

Ronen E

Just a person
Staff member
Super Moderator
#11
Good morning,
here comes an awkward question :)
I am a medical devices CER writer and I am looking some (official, wishfully) guidelines on the extent of plagiarism we we "allowed" to practice when writing the State of the Art Section and when appraising clinical data on equivalent devices.
Does anyone have any examples where a Notified Body rejected a CER because plagiarism was detected in these two sections?
Do you think we should treat the CER as an original paper that will undergo peer-review, therefore all plagiarism rules apply, or we could be a bit more flexible given that this is a regulatory document that remains confidential throughout the process?
Any thoughts will be highly appreciated!
Quoting from a source isn't plagiarism if you reference/credit the original author, is it?
 
#12
Quoting from a source isn't plagiarism if you reference/credit the original author, is it?
My understanding of this subject was that if you reference an article then you can't commit plagiarism, but if you are taking verbatim then quote marks and reference makes it clear that these aren't your thoughts.
 
#14
Thank you both, this has been my understanding too but lately I was told by a client that neither quoting, no verbatim with quote marks is allowed in CERs and that we are not allowed to use not even one phrase from an article despite proper citation/reference.
So this has stricken me as sth very odd and I am trying to find out whether there is actually such (or a similar) guideline.
Why would CERs be any different than any other medical and regulatory paper? Good Publication Practice applies in CERs no?
 
#15
I'm not aware of anything that would preclude you from doing this. With a cynical hat on I suspect the reason for this is to make sure the report is written and explained, rather than copied from the paper. I had an experience of this recently whereby the person writing the report was copying the authors study conclusions and sometimes the authors were overselling their work.
 
#16
I'm not aware of anything that would preclude you from doing this. With a cynical hat on I suspect the reason for this is to make sure the report is written and explained, rather than copied from the paper. I had an experience of this recently whereby the person writing the report was copying the authors study conclusions and sometimes the authors were overselling their work.
Yes, this is my understanding of the situation as well but I thought I should make sure I am not missing any particular writing guidelines. In any case, to establish the state of the art related to a medical device, a critical interpretation of clinical data is required, so frankly I do not see how someone could pull it off by plagiarizing whole sections of text. But still someone saying that not even guidelines should be verbatimed along with quotation marks and proper reference of the original citation is a bit extreme
 

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