Source Data Verification expectations during COVID-19

May 4, 2020

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

 

Remote monitoring SDV and SDR expectation highlights

FDA1

If planned on-site monitoring visits (MVs) are no longer possible, sponsors should consider optimizing use of central and remote monitoring programs to maintain oversight of clinical sites.

EMA2

If on-site is no longer feasible, alternative methods to be considered: postpone SDV and SDR, phone and video visits, centralized monitoring and centralized review of data. Remote SDV not allowed in most member states, also provision of redacted SD from sites not allowed as puts disproportionate burden to site staff. any option of remote access deemed nevertheless possible to be used will need to be clarified with the relevant authority (Ethics Committee (EC), data protection agency etc.) and hence not allowed unless specific approval given

MHRA3

Remote monitoring can be considered, to consider use of direct access to electronic health records (must maintain confidentiality, consent from participants needed). Do not overburden sites with scanning requests.  OK to reduce monitoring visits without substantial amendment but needs risk assessment.

Health Canada4

Monitoring activities may need to be re-assessed and should prioritize critical activities to ensure participant safety.  It is advisable to document any changes and their impact. Processes may need to be changed: for example, an electronic alternative may have to be considered in place of a wet ink signature.

Australian Department of Health5

Remote MVs are encouraged as the first option in all cases and sponsors and institutions should ensure that these are facilitated, taking into account the need to avoid undue burden on hospital or institutional resources. These arrangements must adhere to patient confidentiality protocols already in place. Remote SDV may be done electronically as long as appropriate security arrangements either are or can be put in place.

 

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:

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

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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