As monitors we spend a significant amount of time reviewing the Investigator File and the essential documents filed with in it at a site visit. There are many things we look for; here are just a few:
- Are all the pages there? This of course can vary from document to document. Some will consist of one page but many have multiple pages to the document. If the first page is labeled 1 of 20, are all 20 pages filed?
- Are all the versions filed? As you know there can be multiple versions of various essential documents. Sometimes there are multiple protocol versions, informed consents, and investigator brochures, just to name a few. Are all the pages contained the correct version? And are all versions filed?
- Have there been any updates? Did the Sponsor send a new protocol to the site but it hasn’t been filed? Do they have the IRB documentation? Would there be a new informed consent? Has the site been trained? How is it documented?
- Are there complete signatures where required? Lots of essential documents have signatures, some from the Sponsor, some from the site, some are from the monitor. Are all the signatures present and complete? Now is the signature a “wet ink” version?
Let’s discuss wet ink signatures. How important are they? Should the site only keep copies in the Investigator File except for ongoing documents, i.e. a delegation log or a site visit sign in sheet? Should then all other wet ink versions be stored with the Sponsor? And what about monitoring reports and letters to the site, who should file those wet ink versions?
With so many essential documents, and so many of those that requiring signatures, how do Sponsors determine who files the wet ink and who files the copy? Especially in today’s world, when so many documents are scanned and submitted? Are copies as good as wet ink versions?
In our experience we find generally Sponsors are keeping some items in house and some filed at the site, and oftentimes whether the signature is wet ink or a copy is irrelevant. Other Sponsors opt to keep all wet ink versions in house, only allowing the site to temporarily keep documents that are on going with wet ink signatures and then collecting those at the closure of the study.
What do you think? For Sponsors, are copies as good as wet ink signatures? How do you decide when an original signature is required, and when a copy is sufficient?
Photo Credit: Robert Burdock