Hi everyone, I’m newer to the industry and had a general question-I’m looking at the DIA TMF Reference Model, which looks great, but I’m wondering if it’s ok to modify it to fit particular needs, such as deleting certain artifact numbers or changing certain things in the naming convention. Can I change things to fit my needs, basically.
This topic was modified 8 months, 2 weeks ago by Leanna Ross.
The CDISC Reference Model is not a mandatory standard so you can adapt it to suit your needs. However, most of this community would likely advise against. The model has been developed by hundreds of practitioners to reflect best practice and inspector expectations. If you make changes, you’ll likely be out of line with what the rest of industry is doing. Inspectors might struggle to find things. Other partners (eg CROs) will have similar problems. I’d advise keeping as close to the model as possible.
I am adapting it to suit the needs of the CRO I work with. To do this I am keeping the same structure and adding a line next to to artifact names to state what our equivalent named document would be.
There are always going to be a zone/section/sub-section that wont be required in a particular study so adapting it to the study should be a discussion with the sponsor too. In my opinion I don’t agree with having empty sections with a file note to say it is not in use for this study – if you will never use it don’t put it in.