Routine or Interim Monitoring Visit describes any visit that occurs after the Research Site is initiated until the site is closed out. The objective of these visits is to assess the progress of the trial in terms of accuracy and completeness and verify reported trial data (SDV/Source Data Verification).
Each visit to the Research Site typically takes fours hours or longer. These lengthy visits can be limited when utilizing the full power of Remote Monitoring. First we are going to explore what a traditional Interim Monitoring Visit entails then we will cover what can be accomplished when using technology to enable Remote Monitoring.
Before a Traditional Interim Monitoring Visit
Timing is everything. Both the timing and frequency of Interim Monitoring Visit depends on a number of factors including but not limited to; complexity of the protocol(s) in question, disease being studied, rate of recruitment, Principal Investigator and/or staff experience, site performance and the Sponsor’s Standard Operation Procedures (SOP).
The frequency of IMVs is not dictated by FDA regulations, but the FDA will hold the Sponsor accountable for their SOPs.
Expectations During a Traditional Interim Monitoring Visit
Site Expectations of Monitor
Monitor will come prepared.
Be knowledgeable about the protocol.
Communicate honestly about findings.
Show cooperation, respect, and courtesy.
Appreciate the effort that went into the preparation.
Review study documentation.
Monitor Expectations of the Site
Site will have prepared for the visit.
Records will be organized so they can work efficiently and finish on-time.
Site Preparation for a Traditional IMV to be Successful
Prepare the Room and Records
Request medical records to be reviewed.
Arrange for a quiet room.
Inform pharmacy of visit and schedule appointment.
Make sure PI and AIs will be available for monitoring date.
If multiple monitoring visits occur simultaneously, make sure each sponsor has a separate room to ensure privacy and confidentiality.
Review Regulatory Binders
Make sure Regulatory Binder is complete and up-to-date:
All protocol versions and approvals.
All Investigator Brochure versions.
Lab certifications and normal ranges.
All versions of Form 1572.
CVs, licenses and financial disclosures for all Investigators – signed and dated.
All IRB correspondence.
All Sponsor correspondence.
Update Delegation of Responsibility/Signature Log as needed.
Assure IRB receipt of:
Assure all participant original consents are in the medical record, signed & dated.
Review Source Documents
Assure medical records contain
All laboratory reports.
X-ray, scan reports.
Physician notes, nursing notes.
Drug compliance/administration notes.
Procedures documenting study parameters reported in CRF’s.
Informed consent process documentation.
Obtain missing information or document why unobtainable.
Flag the medical record to assist monitor’s retrieval of information in a time-efficient manner.
Make sure laboratory reports and procedure reports are reviewed and signed by PI (if required per sponsor SOP).
Assure CRF’s are complete, accurate, up-to-date.
Review adverse events.
Assure attribution of events is documented.
Review concomitant medications.
Assure stop & start dates are recorded.
Review study medications.
Assure stop & start dates are recorded.
Review Pharmacy Records
Pharmacy should review drug dispensing records prior to visit.
Drug Accountability Record Forms (DARFs).
Assure drug count is accurate.
Disposal of returned medications.
Assure notes to file are written for any discrepancies.
Inform PI of discrepancies.
After a Traditional Interim Monitoring Visit
After the Monitor completes the IMV, they meet with the PI and/or RNto review all the information gathered and analyzed throughout the process. This information includes but is not limited to; all laboratory reports, findings, needed corrective actions (if applicable), and remedial training needs (if applicable). The Monitor and PI/RN also answer each others questions and set up the next visit.
The Monitor will sign the Visit Log, if they have not already done so, and site staff will initial. All medical records are returned to the correct area, rather that be Medical or Legal.
Within the agreed upon timeline, the site answers all queries or clarifications needed. These answers may address corrected CRF’s to be sent to the monitor or picked up at the next visit. The monitor sends the monitoring visit report, which is then placed in a Regulatory Binder by the research Site. A follow-up letter is also issued by the Monitor of thanks and confirmation of the next visit.
Interim Monitor Visits with Remote Monitoring Enabled
Fully-Remote Monitoring Visits to review regulatory documents, study data, consent forms, and source files is now possible when working with research sites that manage their studies in an eISF.
When sponsors or CROs use Florence eHub, the site eISF directly integrates with the eTMF for automated routing of documents.
Jordan Tapley, a Florence Senior Consultant explains, “The Interim Monitoring Visit (IMV) has the most to gain from Remote Monitoring capabilities. CRAs can now access the Research Site from anywhere, at any time, to review documents and source data – as well as assign tasks to Sites.”
A majority of the IMV can take place remotely. Anything related to document, data, and source review can be completed remotely by the Monitor. Tasks and notes can be attached to all files and documents for the site to review and follow-up.
Site Tips for Remote IMV with eISF
Grant Permissions to the eISF
Review permissions for the monitor and ensure monitors can only review appropriate documents during the visit.
Schedule the visit date and time with Access Dates.
Review Dashboard for Missing or Expired Documents
Look at Global Dashboard for indicators of missing or expired documents.
In Florence eBinders, automatic notifications will notify you of missing and expired documents in advance so you can assign tasks to complete the documents.
Interim Monitor Visits with Florence eHub
Monitoring through Florence eHub allows CRAs/ Monitors to generate automated monitoring reports that track documents reviewed, notes made on documents, follow-up and action items, and documents to review next visit.
Monitor study progress in real-time across all Research Sites with global dashboards and milestone reports.
Easily pick up where you left off in the last monitor visit by quickly identifying the documents new to the eISF since your last view, documents that were updated since your last view, and documents you flagged to review on the next visit.
Ensure compliance by reviewing automatic audit trails of all documents and folders in the study.
Review Source Documents (Source Data Verification) with direct eISF integrations into the EMR/EHR that eliminate the need for EMR credentialing and shadow charts.
Assign follow-up tasks to site staff during your visit that are automatically routed to the appropriate person and tracked for review.
Generate automatic monitoring reports of your visit, the documents you viewed, notes you made, and follow-up action items.
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