Schrems II Update

VeraSafe is closely monitoring the Schrems II decision of the European Union Court of Justice. Please contact VeraSafe if you are relying on the Privacy Shield Framework.

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Changes to Clinical Trials due to Covid-19

Due to the impact of the COVID-19 pandemic on clinical trials, the European Medicines Agency (EMA) along with several other European medical bodies have drafted the EMA Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic (the “EMA Guidance”). The EMA Guidance informs clinical trial sponsors about suggested changes to clinical trials necessary to limit the spread of the pandemic and ensure clinical trial participant safety. It also attempts to codify current EU Member State guidance on this topic into a unified approach for the EU. 

This article (1) summarizes the advice of the EMA on suggested modifications for your clinical trial processes in the time of COVID-19, (2) provides further practical steps you can take to improve your processes, and (3) examines additional data privacy considerations.

The EMA’s Recommended Modifications to Clinical Trial Processes

Conduct Continual COVID-19 Risk Assessment

  • You should conduct a continual risk assessment, balancing clinical trial participant safety against the benefit of the study and data validity when considering whether to start new clinical trials, continue existing clinical trials, or change the clinical trial process in existing clinical trials. This risk assessment exercise should be documented in a formal, written instrument and be kept available in the event of regulatory audit or inspection.
  • You should ensure that clinical trial participant safety is paramount in any decisions taken.
  • Any changes to the clinical trial process should be made in consultation with all relevant stakeholders and properly documented (for example, in the study protocol, monitoring reports, clinical study reports, and informed consent forms (ICF)).
  • You should ensure that this continual risk assessment and consideration of participant safety encompasses all aspects of the clinical trial, including data privacy concerns.

Communicate with Authorities

  • In the case that any event related to the pandemic (for example, a local change in circumstance caused by the pandemic) changes the continual risk-benefit analysis mentioned above, and urgent measures are needed to mitigate these risks, you may implement these measures without prior consultation with the relevant authorities.
  • You should record these urgent changes as part of the clinical trial process in the study protocol and inform the relevant National Competent Authorities (NCA) or Ethics Committees (EC) for the relevant EU Member States of these changes or measures as soon as reasonably possible once implemented. You should describe the cause of the risk, measures taken to mitigate the risk, and plans for future action related to the risk.
  • If any event would cause a significant safety risk to clinical trial participants or a risk to the scientific value of the trial, but would not require immediate action from the sponsor or investigator, you may make a substantial amendment application to the study submission, to be approved by the relevant NCA or EC before the implementation of any changes to the clinical trial process.  

Accord Changes to the Clinical Trial Process with Study Sites and Communicate Changes to Clinical Trial Participants

  • You should clearly communicate all changes made to the clinical trial process to study sites and accord such changes by way of redline to the relevant agreements with the study sites. Study sites should also, in time, inform clinical trial participants of changes to their processes (for example, cancellation of visits, or changes in laboratory testing or delivery of IMP).

 Implement Changes to the Informed Consent Process

  • You should consider avoiding physically delivering written ICFs to or from clinical trial participants, and you should ensure that ICFs do not leave quarantined rooms containing potentially COVID-19 infected clinical trial participants, for safety reasons. This presents difficulties with obtaining signed ICFs for record and submission purposes, however the EMA Guidance proposes solutions to these problems.
  • You may alternatively, in order to prioritize clinical trial participant safety, collect consent from clinical trial participants orally, however such consent must be given in the presence of at least one impartial witness, who must sign an ICF (it is assumed that this witnessing could be conducted electronically, such as by teleconference).
  • You may facilitate signature of separate ICFs by clinical trial participants and impartial witnesses, and collect the participant’s ICF to be filed at a later stage. The investigator should include a record of how the impartial witness was selected along with the ICF.
  • Where a clinical trial participant is too ill to consent or where there is no time to obtain consent due to the participant’s critical condition, you may obtain such consent at a later stage, or obtain consent from the participant’s legal representative, as applicable.
  • You should obtain renewed consent from clinical trial participants in the event of any changes to the study to account for the COVID-19 pandemic, if relevant. You should obtain this renewed consent remotely, should update existing ICFs accordingly, and redistribute ICFs to clinical trial participants.

Implement Changes to Sponsor/ CRO Clinical Trial Monitoring to Limit On-Site Monitoring

  • You should consider changes to remote monitoring processes by yourself or your CRO, for example, implementing centralized telephone or video monitoring in order to limit physical on-site monitoring. You should only make these changes in consultation with relevant local legislation and guidance, as well as specific guidance from the relevant local authorities.
  • The CRO should record any changes to monitoring processes in the monitoring report to the sponsor and you should record these changes in the clinical study report. You should implement robust follow-up measures such as increasing on-site follow up once the COVID-19 restrictions in each EU Member State are loosened and considering continual COVID-19 risk assessment.
  • The EMA suggests that remote data verification by the sponsor (such as sharing anonymized clinical trial participant medical files directly with the sponsor, or providing the sponsor with electronic access to these medical files) should be considered by the relevant Ethics Committees and National Competent Authorities in each Member State, however the EMA makes it clear that these measures are not currently allowed in most EU Member States. You should only consider implementing these measures in consultation with relevant local legislation and guidance, as well as specific guidance from the relevant local authorities.

Further Practical Changes to Your Clinical Trial Processes

  1. You should implement continual risk assessment when considering the feasibility of starting new clinical trials, in light of the COVID-19 pandemic.
  2. You should consider implementing:
    • conversion of physical visits to clinical trial participants to telephone or video call;
    • a temporary halt on some or all study sites;
    • suspension or slow-down of recruitment of new clinical trial participants;
    • postponement of clinical trials not already started;
    • extension of clinical trial duration;
    • closing of study sites;
    • transfer of clinical trial participants to study sites in lower-risk zones (if unavoidable); and
    • critical laboratory testing and diagnostics for clinical trial participant safety (including conducting such tests and diagnostics at laboratories local to the participant).
  3. You should continue adverse event reporting, including collection of adverse event information via alternate methods (for example by telephone).
  4. You should implement changes to the distribution of IMP, including distributing a larger volume of IMP to clinical trial participants, direct delivery of IMP to participants (where allowed in accordance with relevant local legislation and guidance), as well as implement measures in case of IMP shortage at study sites.
  5. You should consider postponement of audits or conduct remote audits.
  6. You should escalate to the relevant authorities and manage the inevitable increase of study protocol deviations.
  7. You should compensate participants for unexpected expenses arising out of any changes to the clinical trial process.

Additional Data Privacy Considerations – VeraSafe Can Help

The good news is that, should you have a robust and comprehensive data privacy program in place, the EMA Guidance does not require significant changes to your clinical trial privacy program. While some of the suggestions in the EMA Guidance may necessitate the engagement of new vendors and the implementation of new systems, the engagement and implementation process would follow the same vendor onboarding processes. VeraSafe can assist your organization in implementing a robust and comprehensive clinical trial privacy program. Contact us today for a consultation.

Contact VeraSafe to discuss your data security management and privacy program today.