As monitors we spend a significant amount of time reviewing the essential clinical investigation documents at the site during a monitoring visit. These ‘essential documents’ are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator File.
Here are some tips and tricks while reviewing essential documents:
- Are all of 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.
- Are all the versions filed? As you know there can be multiple versions of various essential documents. Sometimes there are several 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 to understand what the site should have filed. During the visit, make sure the correct version is on file and any other previous versions.
- Are there complete signatures where required? Lots of essential documents require signatures, some from the sponsor, some from the site, and some from the monitor. Remember to not only look that the document is there, but whether any required signatures are present. Check with the sponsor’s SOPs; some sponsors may require original signatures to be housed internally, some maybe at the site.
- Do the IRB documents tell a complete story? IRB correspondence can be lengthy, so it is helpful to review it at each visit for recent updates. It is important to verify the correspondence tells a complete story. For example, do all of the submissions have corresponding approvals? Did the IRB respond with questions or require additional documents to be submitted? If the site had to report any protocol deviations or adverse events, are those also filed in the correspondence? Providing submissions, approvals and correspondence provides “evidence that a qualified, independent IRB/EC has reviewed the clinical investigation,” as required by the standards of Good Clinical Practice (ISO 14155 E1.9 and ICH E6).
- CV’s, licenses, financial disclosure, delegation Log and training records. Again it is important to know what the sponsor requires. Then make a chart, this will help you organize who needs to file which documents (site, sponsor, or both), 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 of responsibilities log. This is very helpful to ensure all applicable staff have been added the log, and proof of their training and qualifications to participate in the study are provided.
What are some of your tips and tricks when reviewing essential documents?
Photo Credit: Sean MacEntee