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Compliance In Focus
Posted by Brandy Chittester on Fri, Jul 8, 2016

5 Questions for Coordinators Preparing for a Monitoring Visit

Preparing_for_a_Monitoring_Visit.jpgAs monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself. Before your next monitoring visit, consider asking yourself these five questions:

  1. Has all data been entered? First and foremost, ensure all data has been entered and submitted to the CRO/Sponsor. If not, the monitor has nothing to review and the whole purpose of the visit is defeated. The monitor will then have to sit and wait for data to be entered during the visit, which increases the amount of time on-site as well as the need for further visits.
  2. Have all issues been addressed from the last visit? Take a look at the last monitoring follow-up letter. Are there still open action items? Try to have all outstanding items addressed by the next monitoring visit. If this isn’t possible, at least being aware of the issues and the steps being taken to remedy them will show the item is being addressed.
  3. How is the regulatory binder looking? Perform a quick sweep of the regulatory binder. Has the latest correspondence been filed? Is Dr. Smith’s updated license present? Spending a little time reviewing the binder before the visit will result in decreased time and queries while the monitor reviews it during the visit. Reviewing regulatory items prior to the visit can also result in less follow-up items as missing/expired articles can be corrected beforehand.
  4. Is the PI available for the visit? When possible, schedule an appointment to have the PI meet with the monitor during the visit. It tends to work out better than waiting to grab them as they run between the OR, clinic, and rounds. Additionally, any questions brought up by the monitor can be addressed during the visit, again leading to less follow-up items. 
  5. Have I coordinated meeting times and locations with the monitor? A quick introduction email to the monitor prior to the visit that includes any directions or need-to-know information is always greatly appreciated. Making sure the monitor knows where they’re going reduces the amount of “waiting around” time. Monitors are a flexible bunch, but letting them know any site specifics beforehand (such as only working until 3pm, or that medical records are stored at another location) ensures they can adjust their schedule to get the maximum amount done during the visit.

Do you prepare before a monitoring visit? Let us know in the comments below.

Elements of a Regulatory Inspection | IMARC Research

photo credit: IMGP7646 via photopin (license)

Topics: Research Coordinators, Clinical Monitors


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