When an adverse event (AE) occurs, the member of the study team who first becomes aware of the AE will assess whether the event is serious. If they are unsure of whether the event should be classified as serious, the team member will consult the local PI. All AEs assessed as non-serious, whether expected or not, will be recorded in the participant’s medical notes (if applicable) and recorded on the study database within 7 days. If it is apparent to any member of the study team that a number of AEs have been reported for one participant, they will refer this to the local PI who will review and escalate to the Trial Manager and Chief Investigator (CI), if necessary.

All serious adverse events (SAE) will be notified to the Trial Manager within one working day and an SAE form completed. This completed and signed SAE form should be emailed to the Trial Manager (or delegated person in the absence of the Trial Manager). The Trial Manager will review the SAE form and disseminate to the CI, PI, local R&D, the sponsor, and the appointed clinician who provides clinical oversight for the trial within 72 h of being informed. The DMEC and REC will be informed by the Trial Manager of SAEs periodically unless the CI or sponsor escalates the SAE or deems necessary. If an SAE is considered to be related to the trial intervention (based on a 5-point causality likelihood system: unrelated; unlikely to be related; possibly related; probably related; definitely related), and the intervention is discontinued or interrupted for that participant as a result, this will be recorded in the appropriate sections of the database. At the baseline visit, all participants, parents, and carers will be given information about accessing help locally (e.g. crisis team) should the mental health status of the young person deteriorate.

Note: The content above has been extracted from a research article, so it may not display correctly.

Please log in to submit your questions online.
Your question will be posted on the Bio-101 website. We will send your questions to the authors of this protocol and Bio-protocol community members who are experienced with this method. you will be informed using the email address associated with your Bio-protocol account.

We use cookies on this site to enhance your user experience. By using our website, you are agreeing to allow the storage of cookies on your computer.