By: Felicia Ford-Rice, Director, Strategic Compliance
Following on from part 1, I addressed how to maintain patient privacy in the COVID-19 pandemic. In this blog, I’ll take a deeper look at the use of Remote (Central) Monitoring.
Remote (or central) monitoring can be an acceptable solution to deal with the lack of access to a clinical investigator site as well as to ensure timely communication of critical information from the investigator site to the clinical trial sponsor. Sponsors use remote monitoring to a certain extent for particular studies where it may not be time and cost-effective to schedule on-site monitoring. To support the pharmaceutical industry during a global pandemic with major impact on clinical trials, threatening the health and well-being of patients, health care providers and sponsor representatives, both the US and EU Health authorities have provided guidance for industry related to remote monitoring and patient data privacy. For example:
To conduct remote monitoring the site is required to upload source data and regulatory documents (i.e., laboratory results, medical history, physical exams, vital signs, physician notes, informed consent, case report forms) to a secure portal of virtual workspace accessible to the sponsor for SDV and SDR. In 2019, the US FDA issued a draft Risk Based Monitoring guideline1, which states the following: “A risk-based approach to monitoring should focus sponsor oversight activities on preventing or mitigating important and likely risks to investigation quality, including risks to human subject protection and data integrity. While this was not written specifically for the scenario of a global pandemic, the key elements related to risk planning can be applied.
According to the 2013 US FDA guideline, Electronic Source Data in Clinical Investigations2, source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) which are the principles of data integrity, and must meet the regulatory requirements for recordkeeping. Additionally, it states that capturing source data electronically and transmitting it to the eCRF should amongst other things, facilitate remote monitoring of data. The recently issued US FDA guideline Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic3 states sponsors should “consider optimizing use of central and remote monitoring programs to maintain oversight of clinical sites” with the expectation that trial integrity will be maintained.
The EU Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic4 issued on 20-Mar-2020 is a harmonized set of recommendations for changes in ongoing trials and sponsor risk assessment considerations including, but not limited to, “Conversion of physical visits into phone or video visits, postponement or complete cancellation of visits to ensure that only strictly necessary visits are performed at sites”, supportive of remote monitoring, SDV and SDR.
Moreover, the ICH E6 Good Clinical Practices1 describes the acceptability of centralized monitoring described as “remote evaluation of ongoing and/or cumulative data collected from trial sites in a timely manner.” Prior to the transfer of data from a clinical trial site to the sponsor for the purpose of remote monitoring, it is important to ensure the following: (1) All changes to the monitoring plan required to put remote monitoring into effect (i.e., use of technology - secure portals, Skype or WebEx, scanned documents, cloud-based systems; increased or decreased frequency of monitoring; certified copies vs original records); (2) training of monitors; (3) risk assessment conducted to implement effective restricted access controls so that original data may not be modified, shared or stored; (4) procedural and system controls to ensure source data traceability and data integrity and (5) where authorization has not been approved, that patient identifiers be removed or redacted.
1 A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry, draft, March 2019
2 Guidance for Industry, Electronic Source Data in Clinical Investigations, September 2013
3 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Guidance for Industry, Investigators, and Institutional Review Boards, March 2020
4 Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 1, (20/03/2020)