CATEGORIES: Clinical trial; Compliance; Investigator meeting; Regulatory; Virtual interactive
Sponsors of clinical trials and/or contract research organisations (CROs) are responsible for ensuring that they are compliant with local and international regulations. It is of the utmost importance for the correct documentation to be in place before a clinical study is initiated and for all investigators to be fully conversant with their own responsibilities. Investigator meetings therefore play an important role in ensuring that key guidance, recommendations and legislation are fully communicated to study site teams.
Regulatory information is typically reinforced during the large face-to-face principal investigator meetings that take place shortly before the study drug is distributed to participating study sites. A dedicated session on Good Clinical Practice (GCP) is often built into the agenda to ensure that all sites are familiar with the expected ethical and quality standards (e.g. the correct approach to informed consent).
Virtual investigator meetings are becoming more common in the period after study initiation, primarily due to benefits regarding travel, accommodation, time and convenience. However, there is no practical reason why face-to-face principal investigator meetings could not also be replaced with a virtual alternative over the long term – virtual meetings allow delivery of training and presentations online, with the added potential for simultaneous online learning and assessment. Therefore, there are no differences in the regulatory requirements involved with conducting virtual investigator or virtual interactive (Vi) investigator meetings, compared with the face-to-face equivalent.
Despite the fact that the majority of virtual investigator meetings are taking place after study initiation (when many of the regulatory requirements should have already been fulfilled, e.g. GCP training, development of a monitoring plan, etc), there are still situations in which it is important for study sponsors and their respective agencies to be conversant with the regulatory environment; for instance, some sites may enter the study late, there may be changes to the study protocol or CRF that may need to be communicated, or sites might experience challenges with institutional review boards/ethics committees. In addition to local and international guidance, the main requirements for a well-conducted virtual investigator meeting are to be professional, engaging, educational (non-promotional), scientifically accurate and help the sponsor keep the study plan on track.