Clinical Trial Study Reports - SOP

S

Schultzey

#1
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.
 
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Stijloor

Staff member
Super Moderator
#2
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.
Comments?

Thanks.

Stijloor.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
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.
Hi,

Have you tried this resource?

http://www.ghtf.org/sg5/sg5-final.html

Cheers,
Ronen.
 
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