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Hi all,
I tried searching around a bit and could not find clear answers to what I am looking for. Here is a little background on what I am doing.
I work for a medical device company and I am writing an SOP on Clinical Trial Study Reports. We only do business in the US right now but I would like to include in the SOP EU and OUS requirements in case things change.
So far I have found ICH E3 to be helpful in writing this document. I want to know if there are any other documents applicable to clinical study reports(CSR) I am overlooking?
Also, it is unclear in ICH E3 who is responsible for completing the CSR and who it must be submitted to. Could anyone clear this up for me? Thanks in advance.
I tried searching around a bit and could not find clear answers to what I am looking for. Here is a little background on what I am doing.
I work for a medical device company and I am writing an SOP on Clinical Trial Study Reports. We only do business in the US right now but I would like to include in the SOP EU and OUS requirements in case things change.
So far I have found ICH E3 to be helpful in writing this document. I want to know if there are any other documents applicable to clinical study reports(CSR) I am overlooking?
Also, it is unclear in ICH E3 who is responsible for completing the CSR and who it must be submitted to. Could anyone clear this up for me? Thanks in advance.