Corona virus - extraordinary measures for clinical trials
On 24 April 2020, the Danish Medicines Agency updated their guidance on extraordinary measures for clinical trials due to COVID-19.
The main updates to the guidance are:
- Opportunity to establish remote access to source data under certain conditions (item 3); and
- Deadlines are postponed to 1 September 2020.
The COVID-19 pandemic still entails a restrictive access to clinical trial sites, which disrupts on-site monitoring. In order to counteract serious consequences to data validity, the opportunity to establish remote access to source data has been opened. In dialogue with the Danish Data Protection Agency, the Danish Medicines Agency has laid down general terms and a number of specific terms that must be met in connection with remote access to source data.
The guidance contains the following general terms:
- Establishing remote access must be in accordance with the principles of necessity and proportionality and must always be done in a way that protects the rights of the participants and does not place unnecessary burden on site staff. The sponsor must never put pressure on the investigator to establish remote access to source data;
- Remote access to Danish source data may only take place from a location within EU/EEA;
- Access must be established under secure conditions. The location must ensure that outsiders cannot overlook the process. This includes a secure connection on a machine protected from unauthorized access;
- Monitor and involved site staff must be trained in the process; and
- The principal investigator and the institutions data officer must assess the necessity for sponsor/monitors to sign specific contracts, e.g. a confidentiality agreement and monitors committing not to make any additional copies (or recording in the case of video access) of any non-pseudonymised document, etc.
The specific terms relate to the below methods:
- Electronic remote access to patient records and other source data;
- Video conference where source data is reviewed with help of site staff; and
- Transfer of pseudo-anonymised copies of source documents.
The remote access must comply with GDPR. In this connection, a separate risk assessment must be prepared regarding data protection for the established procedures.
A substantial amendment must be submitted to the Danish Medicines Agency if sponsor wishes to introduce remote access to source data. Restoring normal practice and notification is postponed to 1 September 2020.
Furthermore, the Danish Medicines Agency recommends, in a newsletter of 27 April 2020, that sponsors of clinical trials regularly reconsider the risk assessment of the study, including whether the level of activity should be tightened or relaxed under the concerned conditions, for instance whether the recruitment for clinical trials should stopped temporarily or resumed.
The entire guidance can be found here.
The newsletter of 27 April 2020 can be found here (in Danish).