Why must both CRO and a client company have a subscription to MedDRA?
It is the intent of the ICH , the creators of MedDRA, and the IFPMA, the holders of the property rights to MedDRA, that all pharmaceutical companies have a current MedDRA license in order to code, analyze, report, or hold MedDRA coded data. CROs who code, report, or hold MedDRA coded data must also have a current license to MedDRA. Otherwise the sharing of data violates the MedDRA licensing agreement created by the IFPMA regarding the distribution of MedDRA to another party.
Related Questions
- My corporation has purchased a subscription to MedDRA. Can copies be made of MedDRA or can MedDRA be shared with other parts of the company or corporation?
- What are the principal client/customer benefits of the new company organization? Any negatives?
- Why must both CRO and a client company have a subscription to MedDRA?
