Dear Forum,
I am studying clinical research management in my 5th semester. For my current term paper I am looking for design history files. I can't find an example anywhere to get an idea of this document. In this forum I have already read that it can be between 100 and 10000 pages. I also realize that no one will give me their original DHF. But is there somewhere the possibility to find examples at least for some sections?
For my term paper I need especially the verification, the design review and design changes. Theoretically I know from the FDA guidelines what belongs there, but it is hard to write about it without ever having seen a DHF.
Please help me.
Best regards Katrin
I am studying clinical research management in my 5th semester. For my current term paper I am looking for design history files. I can't find an example anywhere to get an idea of this document. In this forum I have already read that it can be between 100 and 10000 pages. I also realize that no one will give me their original DHF. But is there somewhere the possibility to find examples at least for some sections?
For my term paper I need especially the verification, the design review and design changes. Theoretically I know from the FDA guidelines what belongs there, but it is hard to write about it without ever having seen a DHF.
Please help me.
Best regards Katrin