Annex 2 provides “additional GCP considerations, focusing on trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD)”. Although ICH-GCP’s focus is on clinical trials with medicinal products, the new guidance specifically the ones on RWD can be relevant for medical devices Post-Market Clinical Followup studies. These considerations include but are not limited to:
Ethics – the need for IRB/ EC involvement in accordance with applicable regulatory requirements and appropriate Informed Consent processes,
Privacy and Confidentiality – in line with EU Regulation 2016/679 (“GDPR”), study sponsors must ensure that security safeguards are in place to protect the privacy and confidentiality of the personal information of trial participants,
Data collected – study sponsor should ensure the fit for purpose of RWD , data sources, access to and use of RWD, and in case of remote data collection ensure attention for adequate cybersecurity and data privacy,
Safety Assessment and Reporting – management of safety information is an essential part of clinical trials to protect trial participants’ safety through early detection and management of potential adverse drug or device reactions and should be in line with the applicable regulations, i.e. EU Regulation 2017/ 745 (“MDR”) for medical devices.