The EMA has released an updated version of their guidance on the management of clinical trials during the COVID-19 pandemic. The newest guidance contains more detail on the use of remote source data verification (rSDV) as a monitoring tool in clinical trials.
The updated guidance details several scenarios in which trials can use rSDV. It includes trials:
- Involving COVID-19 treatment or prevention
- Investigating serious or life-threatening conditions
- Where the absence of SDV for critical data may likely pose unacceptable risks to participants’ safety or the reliability/integrity of trial results
- 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
- In pivotal trials.
Whilst rSDV is available to trial sponsors, the guidance notes that it can only be carried out in agreement with investigators who should make their own assessment as to whether or not it is feasible at their clinical trial site. It is imperative that rSDV is not carried out unless adequate data protection, including data security and protection of personal data even if pseudonymised, is ensured.
In addition, the guidance contains an annex detailing the protection of trial participants’ rights during rSDV. This annex states that the principal investigator, their institution and the sponsor may be jointly responsible as controllers for ensuring information is safeguarded. The annex then goes on to detail various procedures which should be completed such as a documented risk assessment on the risk to trial participants if no source data verification is conducted in the near future, consultation on the feasibility of rSDV with their data protection officer (DPO) and the training of site staff and monitors on the rSDV process.
By increasing the scope of rSDV, the EMA aims to minimise the disruption to clinical trials during the pandemic whilst simultaneously maintaining high quality trials that don’t infringe participants’ rights or risk their safety.
The full guidance can be found here.