Source Data Verification expectations during COVID-19

It is hard to grasp the full extent of disruption brought on by COVID-19 across everything it touches, and clinical trials are no exception. Regulatory authorities have been issuing guidance over the past weeks on conduct of clinical trials during this pandemic. Most indicate that remote monitoring should be considered in cases where on-site monitoring is no longer feasible.

While central and remote monitoring have, to an extent, been used for a number of years, COVID-19 serves as a catalyst in its wide-spread adoption during the pandemic. And while some monitoring activities can relatively easily be performed remotely (e.g. consistency checks, data completeness, protocol deviations, etc.), Source Data Verification (SDV) and Source Data Review (SDR) pose a challenge due to their nature.

The table below summarizes the highlights on monitoring activities, underlining SDV and SDR guidance from some authorities, with the following commonalities:

• Remote monitoring is an acceptable alternative
• Remote monitoring including remote SDV and SDR must not place an added burden on sites (e.g. scanning, redacting, etc.)
• Pragmatically a near-term reduction in on-site SDV and SDR is expected, with an anticipated increase longer-term
• Remote SDV and SDR via direct medical records access possible with explicit approval from relevant authority

Of note, the table above summarizes the recent guidance by the key regulatory authorities, as the pandemic continues this will likely evolve. Additionally, it is advisable to always have a close look at the local requirements as well, as they may differ in their approach.

How can Parexel help?

Parexel can conduct GCP investigator site audits remotely in this global restricted access period. We provide an independent evaluation of trial conduct and compliance as well as independent feedback of the continued standards of quality of clinical trials at sites that can no longer accommodate physical visits. The audit scope supports maintaining an oversight of the clinical trial whilst ensuring the rights, safety and wellbeing of the participants. 

Additional information on how Parexel can assist with GCP as well as GMP remote audits can be found here:

• {CCM:BASE_URL}/solutions/consulting/regulatory/gmp-regulatory-compliance
• https://regulatory-access.parexel.com/brochures-and-factsheets

For more information please contact us. 

References

¹ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

² https://www.ema.europa.eu/en/documents/press-release/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic_en.pdf

^{3​​​​​​} https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19

⁴ https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html

^{5​​​​​​} https://www1.health.gov.au/internet/main/publishing.nsf/Content/EE207D978A44E4B8CA257FA90081B212/$File/CTPRG%20Statement%20on%20Clinical%20Trials%20during%20COVID-19%20at%20260320.pdf

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