My mission is to draft a procedure related to ISO 14155 - Good Clinical Investigation Practices

Y
#1
Hello,

I'm new to the field of regulatory affairs and as part of my internship, one of my mission is to draft a procedure related to the ISO 14155 standard.

Currently, there is no procedure for this standard (it is a young medical device compagny and we want to put our first MD (class III) on the EU market).

But by reading ISO 14155, I do not clearly understand the sponsor's roles during a clinical investigation.

When I started, I first wrote a "Clinical Investigation Plan" work form and an informed consent document.
But they explained to me that these documents will be written and used by our CRO (a subcontractor).

My questions are : Does anyone have an example of a procedure related to the use of ISO 14155 in a company?

And in relation to this norm, what is clearly the role of the sponsor (the company and the sponsor are they identical?), the CRO and the investigator? Especially in a documentary way.

Do we (the company) simply have to say that we want our CRO to have all the documents mentioned in the ISO?

Thank you very much for your time!!
 
Elsmar Forum Sponsor
Y
#2
Well after some researches, I approximately know the obligations of the compagny (the sponsor).

But, according to the standard, all these responsabilities can be transfer to a contractor (like a CRO). So, what should absolutly be under the control of the compagny? If we assume that everything that can be done by a subcontractor will be.

Thank you!
 
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