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We have to re-consent patients in an ongoing trial. How do we document this during pandemic?
Rita Purohit
Considering the safety of patients and risk of contracting Covid-19, a visit by clinical trial participant for the sole purpose of obtaining re-consent should be avoided. If re-consent is necessary for the implementation of new urgent changes in trial conduct e.g., reasons related to Covid-19 or important safety issues for non-Covid trials, alternative ways of obtaining re-consent would be by contacting the trial participants via phone or video-calls and obtaining oral consents. The consent process should be documented in the trial participants' medical records. Updated patient information sheet and consent form, approved by EC should be provided to trial participants by the investigator by e-mail, or courier before re-consent is obtained. Any consent obtained this way should be documented and confirmed by way of usual consent procedures - signed and dated paper copy - at the earliest opportunity when the trial participants are back at the regular sites.
In which situations during pandemic remote source data verification (SDV) is justifiable?
Dr Hemant Mavlankar
Remote source data verification is acceptable during covid-19 pandemic for the following clinical trials:
• For Covid-19 treatment or prevention
• For serious or life-threatening conditions
• When absence of source data verification for critical data is likely to pose unacceptable risks to participants’ safety or the reliability/integrity of trial results
• Involving vulnerable participants such as children or those temporarily (e.g., trials in emergency situations) or permanently (e.g., trials in patients with advanced dementia) incapable of giving their informed consent
• For pivotal trials.
What approaches are acceptable for remote source data verification? Ravindra Gupta
It is the investigator’s responsibility to allow any of the following approaches for remote source data verification:
• Providing anonymized or pseudonymized copies of source documents electronically to the monitor
• Controlled remote access to trial participants’ electronic health records
• Review of medical records by video.
In all situations, protection of the participant’s rights for privacy and confidentiality should be ensured by appropriate measures. The monitor should access the records securely, complete the monitoring task, securely destroy any copy made locally and provide a certificate of destruction to the trial site.
Do we need to conduct monitoring site visit physically after remote monitoring of the data during pandemic?
Poornima Mehta
European Medicines Agency’s 2021 Guidance on The Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic recommends:
The sponsor should plan robust follow-up measures ready to be implemented when the pandemic situation is normalised. This should include increased on-site monitoring for a period that is sufficient to ensure that the impact of the reduced monitoring can be rectified, and problems resolved or properly documented. Data subject to remote source data verification are likely to require re-monitoring, 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.
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