14 Mar Five vital points to prepare before site monitoring
What is Site Monitoring?
According to the Food and Drug Administration aka FDA, a clinical site monitoring visit typically involves a handful of objectives. These objectives can be identifying data entry errors and other discrepancies, or assessing compliance and the clinical site’s staff’s understanding of the given protocol and other procedures. During an on-site monitoring visit, the monitors typically review the given clinical site along with other documents to ensure that it meets the given requirements and best practices.
How to prepare for a site monitoring visit?
A site monitoring visit is an important step. It’s to ensure that a clinical operation is maintaining quality and compliance throughout the entire process. Conducting a well-prepared site monitoring visit can help a lot in maintaining the quality and efficiency of a clinical trial. A site monitor should follow these following five vital steps to make sure that the entire process of a given clinical operation is going on as required –
- Review Data Entry – A site monitor should ensure that the data regarding subject enrollment and their follow-ups should be complete, original, and validated.
- Review Data from the Last Clinical Monitoring Visit – A site monitor should make sure that the data acquired from the last monitoring visit is complete before starting a new visit data entry.
- Review the Regulatory Binder – A site monitor should review the regulatory binder before starting a new data entry to ensure that the licenses for various equipment used haven’t expired.
- Invite the Principal investigator to the Monitoring Visit – It is always a good choice for a site monitor to call the principal investigator at the beginning of a clinical trial because there’s a possibility that the PI is absent or busy, and this may hinder the entire process.
- Check Meeting Times and Locations – Reviewing meeting times and locations before starting a clinical trial is a good choice because this avoids wastage of time for the site monitor.