Observational Study of the Safety, Tolerability and Efficacy of cannabis-based medicine

This is an observational, multicentre study conducted in Australia with patients who are about to start a therapy with MC-1019 and/or MC-1022 for the management of chronic pain. Patients are to be enrolled into the study no earlier than the Consenting Doctor’s decision to initiate treatment with MC-1019 and/or MC-1022. It is mandatory that the prescriber’s decision to start treatment with MC-1019 and/or MC-1022 was taken independently and before the decision to give the patient the option to participate in the study. Consenting Doctors' clinics will be asked to progressively enrol eligible patients until the maximum inclusion threshold is reached. Participants will be followed monthly for a maximum of 24 months from the signing of the informed consent or until death, withdrawal of consent, loss of follow-up/record, whichever comes first. During the follow-up visits (which will take approximately 15-20 minutes every 3 months) assessments will be performed according to routine local clinical practice. De-identified data collected at each visit and reported to the Sponsor. Follow-up de-identified patient reports detailing the required information will be electronically captured and sent to the Sponsor for a maximum of 24 months (Participant reports to be completed electronically each month and/or to coincide with patient visit for follow-up consultation and/or new MC-1019 and/or MC-1022 prescription). De-identified digital reports collected by the online digital platform, C-Trial, using HTTPS encryption and secure storage on an Amazon cloud service with multifactor authentication protected access. Each month participants will log in to C-Trial (a purpose-built electronic data capture platform) and complete online questionnaires. The participant will be provided with an electronic report to complete containing the following baseline information will be recorded by the participant before being supplied with the study treatment, history of smoking, alcohol, and drug use (including cannabis), current medicinal or recreational cannabis. Participant reports: monthly, the anticipated time needed to complete these reports each month is 20 minutes, no additional testing/ imaging is required of participants. The overall duration of participant observation is monthly from enrolment for up to 24 months post enrolment. Participating Doctor induction reports include the following baseline information, History of smoking, alcohol, and drug use (including cannabis), study product indication (chronic conditions and/or chronic pain), current and past medical history, including any mental health conditions, current medications including medicinal or recreational cannabis.