Posted 08 February 2021 | By
The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.
Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivotal trials investigating serious or life-threatening conditions with no satisfactory treatment option.”
In the updated guidance, now in its fourth version, the regulators have dramatically expanded the types of trials that may use rSDV in addition to other established methods for trial monitoring, such as on-site, centralized and off-site monitoring, during the COVID-19 pandemic and in line with EU and national law.
Now, in addition to trials involving the treatment or prevention of COVID-19, the guidance allows for the use of rSDV in trials investigating serious or life-threatening conditions, regardless of trial phase or whether there are satisfactory alternatives on the market.
The guidance also allows the use of rSDV in all other pivotal trials, or in situations “where the absence of SDV for critical data may likely pose unacceptable risks to participants’ safety or the reliability/integrity of trial results” and in trials “involving particularly 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.”
“Taking into account the continuing nature of the COVID-19 pandemic and the need to ensure the quality of clinical trial data and to protect the rights, safety and well-being of the participants in the EU/EEA [European Economic Area], remote source data verification (rSDV) can be justified in clinical trials,” the guidance states.
Sponsors are warned that rSDV should only be used in agreement with investigators and “should not be carried out if adequate data protection, including data security and protection of personal data even if pseudonymised, is not ensured.”
Annex 1 of the guidance, which pertains to safeguarding participants during rSDV, has also been updated to clarify that the principal investigator (PI), the PI’s institution and the sponsor may be jointly responsible as controllers for ensuring that participants’ information is safeguarded.
The Annex also explains that rSDV of medical records of EU/EEA trial participants may now take place in third countries, where it had previously been limited only to remote monitoring locations within the EU/EEA.
“In case the data are transferred/processed outside the EU/EEA, one of the transfer tools under the General Data Protection Regulation (GDPR) needs to be in place; in practice, unless an adequacy decision adopted by the European Commission applies, it should be contractually ensured that a level of data protection essentially equivalent to Union data protection legislation will be applied,” the guidance explains.
Guidance
Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivotal trials investigating serious or life-threatening conditions with no satisfactory treatment option.”
In the updated guidance, now in its fourth version, the regulators have dramatically expanded the types of trials that may use rSDV in addition to other established methods for trial monitoring, such as on-site, centralized and off-site monitoring, during the COVID-19 pandemic and in line with EU and national law.
Now, in addition to trials involving the treatment or prevention of COVID-19, the guidance allows for the use of rSDV in trials investigating serious or life-threatening conditions, regardless of trial phase or whether there are satisfactory alternatives on the market.
The guidance also allows the use of rSDV in all other pivotal trials, or in situations “where the absence of SDV for critical data may likely pose unacceptable risks to participants’ safety or the reliability/integrity of trial results” and in trials “involving particularly 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.”
“Taking into account the continuing nature of the COVID-19 pandemic and the need to ensure the quality of clinical trial data and to protect the rights, safety and well-being of the participants in the EU/EEA [European Economic Area], remote source data verification (rSDV) can be justified in clinical trials,” the guidance states.
Sponsors are warned that rSDV should only be used in agreement with investigators and “should not be carried out if adequate data protection, including data security and protection of personal data even if pseudonymised, is not ensured.”
Annex 1 of the guidance, which pertains to safeguarding participants during rSDV, has also been updated to clarify that the principal investigator (PI), the PI’s institution and the sponsor may be jointly responsible as controllers for ensuring that participants’ information is safeguarded.
The Annex also explains that rSDV of medical records of EU/EEA trial participants may now take place in third countries, where it had previously been limited only to remote monitoring locations within the EU/EEA.
“In case the data are transferred/processed outside the EU/EEA, one of the transfer tools under the General Data Protection Regulation (GDPR) needs to be in place; in practice, unless an adequacy decision adopted by the European Commission applies, it should be contractually ensured that a level of data protection essentially equivalent to Union data protection legislation will be applied,” the guidance explains.
Guidance
"use" - Google News
February 09, 2021 at 06:01AM
https://ift.tt/2Lx85Ou
EU regulators expand use of remote source data verification in clinical trials - Regulatory Focus
"use" - Google News
https://ift.tt/2P05tHQ
https://ift.tt/2YCP29R
Bagikan Berita Ini
0 Response to "EU regulators expand use of remote source data verification in clinical trials - Regulatory Focus"
Post a Comment