MRC Sleep Study - Distribution of IMP

Descriptions

Distribution of IMP to include the following activities: - Receipt of IMP from manufacturing company - Storage on IMP over the duration of the project under temperature controlled conditions - Receipt, check and confirm prescription - Suitable packaging of IMP/non IMP items - Delivery to participant home address (within 48hrs of receipt of prescription) at 5 timepoints - Maintain chain of custody and Accountability- IMPs must be traceable from the pharmacy to the participant, with temperature control, tamper-evident packaging, and delivery confirmation - Destruction of any left over IMP (or return to manufacturer) - Conducting such work as instructed, and in accordance with any relevant protocol / policy / work-instruction, for the duration of the contract. - Compliance with Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment to Regulations when they are applied in April 2026 plus any other applicable regulatory requirements