Reporting of adverse events
ADVERSE EVENTS, RSI
The collection and reporting of adverse events (AEs) will be in accordance with Regulation (EU) No. 536/2014 (Clinical Trial Safety Reporting requirements), the Medicines for Human Use Clinical Trials Regulations (2004) and its subsequent amendments, the UK Policy Framework for Health and Social Care (2017), and the requirements of the Health Research Authority (HRA).As per routine practice AEs will be recorded in the patient’s medical notes including the documentation of the assessment of severity, seriousness and causality (relatedness) in relation to the intervention(s) in accordance with the protocol. The assessment of causality should be made with regard to the Reference Safety Information (RSI) for the GH + arm.The reporting timeframe for adverse events will be from the date of randomisation until the participant reaches near final height or otherwise exits the study. The reporting timeframe for serious adverse events will be from the date of randomisation until the GH stimulation test is conducted at near FH. This will provide a minimum 6-week wash out period for any participants that have been receiving GH therapy.