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Compliance In Focus
Posted by Stephani Hulec on Wed, Jun 17, 2015

Essential Document Review, What are you Looking For?

As monitors we spend a significant amount of time reviewing the essential documents at the site during a Essential_document_review_what_are_you_looking_formonitoring visit.  The essential documents are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator Binder.

Here are some tips and tricks while reviewing essential documents:

  1. Are all the pages there?  Many essential documents contain more than one page, when verifying a document is present make sure to also verify all the pages are there.  If the first page is labeled 1 of 20, double check all 20 pages are filed.
  2. 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. It is a good idea to do some prep work before your visit and make sure the correct version is on file and if there is more than one version, ensure those are also filed.
  3. Are there complete signatures where required?  Lots of essential documents require signatures, some from the Sponsor, some from the site, some are from the monitor.  Remember to not only look that the document is there, but if it requires a signature is that also on file.  Check with the Sponsor and SOP’s, some Sponsor’s may require original signatures to be housed internally, some maybe at the site.
  4. Do the IRB documents tell a complete story?  IRB correspondence can be lengthy, so it is helpful to review it at each visit.  It is important to very the correspondence tells a story, and that all items are indeed filed.   For example, do all the submissions have corresponding approvals? Has the site had to report any protocol deviations or adverse events, are those also filed in the correspondence? 
  5. CV’s, licenses, financial disclosure, delegation Log and training records.  First know what the Sponsor requires.   Then make a chart, this will help you organize who needs what and if any items need to be collected from the site or added to their binder.  You can cross reference the chart with the delegation log.  This is very helpful to ensure all applicable staff have been added the log and in addition they are trained and qualified to participate in the study. 

What are some of your tips and tricks when reviewing essential documents? 

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Topics: Monitor, Regulatory Binder, Essential Documents, Sites


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