This is a no-brainer! You can ensure early in the enrolment phase that procedures are being done correctly. If not, a CAPA can be implemented sooner. The recently issued FDA draft guidance on Risk Based Monitoring (RBM) extols the benefit of an early monitoring visit or other early monitoring activities when determining the timing, types, frequency and extent of monitoring activities. ‘Inadequate monitoring’ remains the most common Sponsor/Monitor/CRO inspection deficiency identified in FDA Form 483 issued at close of CDER inspections. Knowing that, why wouldn’t you do that first monitoring visit soon after the first patient is enrolled to make sure everything is being done correctly? Be proactive in managing risk rather than reactive. I recall asking one CRO PM when they expected to visit a site that enrolled many subjects in a short period of time. I was informed that ‘we are doing risk-based monitoring’ and they would [...]

Location where subjects will be seen: a factor to consider in monitoring activities The recently issued draft guidance recommends that the location where subjects will be seen (and how the data will be collected) relative to where sponsor oversight activities will be conducted, should be a factor you consider when determining the timing, types, frequency and extent of monitoring activities. The guidance was issued in response to questions. It is likely that inspectors have identified this as an issue. Why the location matters The more complex the setting (in-patient vs outpatient) and the more health care providers (HCPs) interacting with the study participant, the more likely a protocol deviation will occur. If it is a protocol for subjects with a long-standing chronic condition, they might be seen at a doctor’s office once a month. Interactions may be limited to the receptionist checking the patient in, the practice nurse, the [...]

The recently issued draft guidance on A Risk Based Approach to Monitoring of Clinical Investigations recommends that turnover at the clinical investigator site or among monitoring staff be one factor you consider when determining the timing, types, frequency and extent of monitoring activities. Turnover at the site Historically a change in personnel at the investigative site warranted an onsite visit by the CRA to ensure that the new research coordinator was trained on the protocol and had been added to the Delegation of Authority log. Depending on the resources at the site, a new coordinator may be able to shadow the RC who is leaving the project. Perhaps they may have been the back-up coordinator and are now taking over primary responsibility for the study. Each situation is unique and should be evaluated accordingly. Setting aside a pool of visits to cover such eventualities makes sense. An on-site visit [...]