Comply With the New EMA CT-C19 Remote Source Data Verification (rSDV) Guidance
Jonathan Andrus
February 25, 2021
And Avoid Undue Burden on Patients and Sites
On February 4, 2021, the European Medicines Agency (EMA) issued CT-C19 guidance v4, an update on the management of clinical trials during the COVID-19 pandemic. Given the impact of COVID-19 on clinical trials and participants, the guidance acknowledges that standard clinical trial conduct may need to be adjusted to enable research to continue.
Accommodations must be made for trial participants entering self-isolation or quarantine with limited access to public spaces, including trial sites, to minimize the risk of spreading infection. Health care professionals prioritizing immediate, patient-care activities also need special consideration.
As a solution, the guidance introduces flexibility and procedural simplifications intended to preserve clinical trial integrity; protect the rights, safety, and wellbeing of trial participants; and safeguard clinical trial staff. Member states are encouraged to “mitigate and slow the disruption of clinical research in Europe during the public health crisis” by implementing the guidance to the maximum possible extent.
“Changes should be well balanced and proportionate, taking into account in particular the legitimate interest of trial sites in avoiding further burden in terms of time and staffing during the COVID-19 pandemic.”
EMA-Issued CT-C19 Guidance v4, Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Epidemic
CT-C19 Guidance for rSDV and Audits Is Nuanced and Specific
While the guidance addresses a variety of activities, such as the completion of trial assessments, the provision of investigational drugs, ongoing recruitment, reconsenting and so on, two sections stand out: modifications for remote source data verification (rSDV) processes and audits.
A risk-based approach is recommended to reassess sponsor oversight responsibilities, such as monitoring and quality assurance activities. Temporary, alternative and proportionate mechanisms of oversight should be instituted as required to balance appropriate oversight with the extra burden incurred for sites.
Sites are then responsible for reporting results of adjusted monitoring and review measures and their impact to sponsors. And once the pandemic abates, sponsors are responsible for robust follow-up monitoring to rectify and document the impact of the reduced monitoring.
“Data subject to remote source data verification are likely to require re-monitoring, in particular if it was based on pseudonymised documents, which cannot be considered as source documents, and considering that remote monitoring is expected to only have focused on the most critical information.”
EMA-Issued CT-C19 Guidance v4, Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Epidemic
Though the authors repeatedly admonish sponsors to avoid overburdening already stressed sites and PIs, the suggested adaptations for rSDV to ensure trial participant safety, data integrity, and personal data protection in the time of COVID seem complex and time- and labor-intensive. That is, if data is collected via standard EDC or on paper records.
An Integrated eSource Data Capture Solution Removes the Burden
An excellent alternative, in this situation, would be Clinical Ink’s Lunexis™ eSource Direct Data Capture Solution. With this system, unlike with standard EDC systems, 85% of clinical trial data is entered directly into the electronic record during the patient visit. The clean, digitized data is then uploaded to a portal in real time, ready to be reviewed remotely.
Such an approach to data collection eliminates time-consuming and error-prone transcription steps and edit checks. There is no paper and no transcription, so no source document verification (SDV) is needed. These major efficiencies eliminate quantities of work under normal circumstances, delivering better quality data for less labor, with reduced timelines. Under the above pandemic guidance, our eSource approach would make a highly fraught task relatively simple.
Consider the below comparison of possible activities to adjust for data collection and verification during the current health crisis using a standard paper or EDC system versus an eSource system, as developed and implemented by Clinical Ink.
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| With Standard Data Collection Methods, Such as EDC and Paper Records | With eSource Direct Data Capture |
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| How to accomplish rSDV, where justified under the new guidance: | |
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| Meet with investigators to determine feasibility of: | |
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✖ Not needed with eSource DDC. |
| Ensure (jointly with PI) the protection of trial data and patients’ personal data, even if pseudonymized: | |
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✖ Not needed with eSource DDC. |
| Describe remote monitoring process in new protocol applications or amendments: | |
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✖ Not needed with eSource DDC. |
| Where redaction is necessary: | |
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✖ Not needed with eSource DDC. |
| For video review of records, consider: | |
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✖ Not needed with eSource DDC. |
Why Stress Site Staff More? It’s Completely Unnecessary With eSource
Clinical Ink’s integrated eSource direct data capture solutions enable companies to largely avoid the issue of rSDV by minimizing the amount of data that needs to be reviewed in that way.
Rather than jumping through hoops to adjust or suspend and later revisit on-site monitoring, sponsors can implement our Lunexis™ eSource solution. Teams will enjoy a seamless transition to ongoing, remote, near-real-time review of electronically collected clinical trial data while protecting investigative sites from a myriad of extra hurdles that would be unwelcome at the best of times.
Industry and regulators are encouraging practical solutions to continue important research during the global crisis without placing any undue burden on site staff. With our eSource solution, sponsors and monitors can log in, look at most data remotely without ever having to bother sites, review it, and be done. It’s that simple.
