How to handle remote monitoring?

EFGCP audit working party discussed the questions regarding to the remote monitoring.

Dr. Beat Widler, Managing Partner at Widler & Schiemann LTD, provided his insights on some questions regarding to the remote monitoring. First, especially BfArM (Bundesinstitut für Arzneilmittel und Medizinprodukte, German Authority) inspectors do not approve such approach, i.e., monitoring and Source Data Verification (SDV) in this context done remotely with the site staff verifying the source data. Such approach blurs the roles and responsibilities between clinical trial center and sponsor (monitor). Site staff should focus on running the trial and manage / support the patients, while the monitor verifies that the protocol is properly implemented and data in the Case Report Form (CRF) are ALCOAC (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).

Q: Is it OK with webex together with the Study Coordinator to confirm certain data points remote before an interim analysis?

A: If it’s an isolated spot-check to confirm some few data points, e.g., data that raised a flag upon centralized data review - then it’s OK.

Q: How do you protect patient integrity?

A: Resolving a few queries over the phone while the monitor queries some data points and the coordinator checking the medical records and then making the required changes in the CRF / completing a query is OK. But if you want to replace monitors visit with off-line sessions where the coordinator in fact is performing the monitor’s task, some inspectors may not consider this to be an acceptable practice.

Q: Could it be other staff from the sponsor viewing the medical records?

A: BfArM in a public event was adamant that even sharing of images of medical records with the sponsor is a violation of data protection as the sponsor could take screen shots and the clinical trial center has no way to ensure this doesn’t happen (and trusting this doesn’t happen is not good enough)

Q: Do you expect the CRA to re-confirm these data-points afterwards during normal monitoring at site?

A: In the scenario - i.e., talking about the verification of some few data points over the phone – there is no need for a reconfirmation by the monitor.

Centralized monitoring has little if nothing to do with remote data verification or remove SDV. Centralized monitoring means a holistic approach of monitoring your clinical data by means of prospectively defined KPIs and KRIs and associated Quality Tolerance Limits (QTLs) plus applying smart statistical tools to identify "data outlier hotspots”. The Tufts paper - to which TransCelerate makes reference - makes clear statements about the value of SDV: SDV doesn’t get any more valuable when it’s done remotely rather than on site. On the contrary, with on-site SDV one waste time of 1 person with remote SDV the same time but of TWO! people.

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