You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
I had an interesting question come up today from a research manager whose site has recently switched to an EPIC EMR system. She asked if copies of data that she had printed out of EPIC for source document verification for an upcoming visit would be adequate for purposes of source document verification.
Topics: Electronic Source Data, EMR, SDV, Direct Access
As technology evolves, it is only natural that there will new ways to consider doing the same task. FDA is catching this wave of the future with the new FDA Draft guidance titled, “Electronic Source Data in Clinical Investigations.” As this draft guidance promotes the electronic age we’re evolving into, FDA hopes this will assist source data overall in clinical research.
Topics: Electronic Source Data, FDA Draft Guidance, Federal Register