The principal of having IRB / IEC approved documents as well as the documents themselves is unmanageable as a concept – version 1 will be finalised at a trial level, then maybe at a country level, then maybe at a site level. They will all be masters, they could all need EC approval. Approval would be an ongoing process, so documents would have to be copied from the master location to the approved location as they are approved. What happens if a trial master is approved at half the sites but not all sites? Does it go in the approved artifact? If it is stored at site level, you could have multiple copies of a single document being stored.
Karen
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