Case Study: Ensuring Continuity of Phase 1 Study During COVID-19 Outbreak

With the COVID-19 outbreak preventing on-site monitoring during a Phase 1 study, SGS quickly implemented an alternative solution.

A multi-center Phase 1 study in participants with chronic hepatitis B was interrupted by the global pandemic, preventing on-site monitoring.

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Key Challenge: Unable to Conduct On-Site Monitoring

With primary analysis upcoming, the COVID-19 outbreak prevented on-site monitoring at several UK sites.

Solutions and Outcome Finding an Alternative Monitoring Method

Since MHRA supports remote source data verification (SDV) where appropriate, SGS implemented remote SDV across several UK sites. The SGS team updated the monitoring plan to document the process and submitted a protocol amendment for an Informed Consent update, required by the MHRA.

After approval from the principal investigator (PI), the involved sites were asked to provide the source documents to the clinical research associate (CRA). These source documents were pseudonymized and sent by email solely to the CRA, who performed SDV by checking the source documents with the electronic case report form (eCRF).

The remote SDV was followed by a phone call with the site, during which the CRA verified whether the documents received by email were complete and discussed the remote SDV findings.

The remote SDV and the phone call were documented in a monitoring visit report and a follow-up letter was sent to the site. Next, the pseudonymized source documents were destroyed and this destruction was documented on a Note-to-File.

During the next on-site visit, prior to final analysis, the CRA will verify that the provided pseudonymized (coded) data is date related to the trial participant with the provided code.