Home Forums Where do I file…. ? Source Document Templates Reply To: Source Document Templates

#5097
Ashley Perez
Participant

We have Sponsor-provided source documents that we file in 05.04.11 (Source Data artifact) if that is helpful to you!

However, I have a similar question: Is it a requirement to file the source templates or just a recommendation? We are filing the Sponsor-provided source templates that have been provided to all sites, but a small handful of sites chose to create and use their own source templates. We are trying to determine if we need to collect their templates to file them in the eTMF, or if it is okay not to.