Clinical trials - Generic "parent" procedure vs. study-specific "child" versions

N

ngoodall

#1
Hello,
This is my first post -- I have found a lot of great information on this site.

I am in the process of formalizing our procedures and was wondering whether someone has a suggestion about how to handle "parent"/"child" procedures, forms, etc. We are involved in clinical trials and work with a number of sponsors, who obviously mustn't see information and procedures related to other sponsors. I have our more general procedures covered, and am now getting into documenting more specific procedures that vary from study to study and sponsor to sponsor. I feel what we need to do is create a "parent" document that is vaguely written, or with placeholders like [SPONSOR] or [STUDY], etc., and have that approved via the usual methods. Once that has been approved, I was thinking about modifying that for each applicable study, as the general procedures would be the same. The information that would change from document to document would be sponsor name, study name, shared drive folder locations and names, etc., and the "child" documents would be kept with study-specific documentation.

Does anyone have a suggestion about how to handle this? Are there better descriptors than "parent" and "child"? Would each "child" document need to be approved as well? We are a small group and I want to do this as efficiently and sensibly as possible, without being accused of overcomplicating things!!

Thanks so much!
 
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