Medicinal Cannabis Clinical Trials (eMCCA113)
Course duration: Allow 2 to 3 hours to complete this training course.
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Medicinal Cannabis Clinical Trials Training to help researchers conducting studies on investigational Medicinal Cannabis products and other herbal medicines
The clinical study training course agenda (listed above) for Medicinal Cannabis Clinical Trials provides examples of key points covered in this online training module for investigational medical cannabis products.
What’s covered in this Medicinal Cannabis Clinical Trials online training module:
- Medical uses of cannabis
- Access to medical cannabis (medical marijuana) through clinical trials or SAS (Special Access Schemes)
- Clinical trial regulations (AUS, EU, USA)
- Regulatory bodies
- Clinical trial design considerations for cannabis and cannabidiol products
- Regulatory compliance guidelines in relation to cannabis/controlled substances
- Australia (TGA guidelines re medicinal cannabis trials)
- European Union (EU, EMA medicinal cannabis guidelines)
- UK (MHRA)
- United States (US FDA cannabis regulations)
- Responsibilities of the Sponsor, Independent Investigator(s), and Sponsor-importer/manufacturer of medicinal cannabis used in clinical trials
- Drug development processes
- Phases of Clinical Trials
- Ethics Committee roles and responsibilities
- Protocol approval processes
- Submission requirements (IND, IMPD, CTA, CTN Schemes and CTX Schemes)
- ICH – Good Clinical Practice (GCP)
- Clinical trial design considerations
- Investigational medicinal cannabis products – handling/storage and distribution
- Documentation requirements
- Clinical trial record retention
Information covered in this training module is explicitly for educational purposes only. Cannabis research regulations, including supply considerations and licencing requirements for medicinal cannabis products for research purposes:
- may vary from region to region
- may change over time with expanding regulations for cannabis use
This eLearning module is an excellent certificate training resource for cannabis industry employees, pharmaceutical quality managers, healthcare personnel, and clinical research assistants involved in the conduct (and ethics) of cannabis research and clinical trials, including reporting of serious adverse events and unexpected adverse drug reactions.
A quick synopsis of what will be covered in this course
Medicinal cannabis clinical trials are designed to:
- Collect data that can be used to address key clinical endpoints regarding the safety and efficacy of the investigational medicinal cannabis product
- Provide information for regulatory authorities to consider approving cannabis medicines for use by patients
- Determine dosing and administration routes and collecting and analysing adverse reactions and adverse events (AEs, SAEs, SUSARs)
GMP compliance and documentation requirements for clinical trials
Regulatory requirements to conduct medicinal cannabis clinical trials using plant-based pharmaceutical products (herbal medicines) and/or synthetic cannabinoids (and related pharmaceutical cannabis products) can vary between different regions.
This course explores some of the Ethics Committee and Regulatory Authority applications for clinical trials (such as the IND applications, CTA (Clinical Trial Applications), IMPD forms and more).
An excellent resource for clinical trial investigators and personnel involved with cannabis research.
This course provides an overview of requirements for conducting medicinal cannabis clinical trials. It includes an overview of design considerations, regulatory approval processes, regulatory compliance, safety reporting guidelines, and product assessment considerations (including mandatory reporting guidelines for adverse drug reactions (ADRs) or serious adverse events (SAEs) related to medicinal cannabis product use.
Regulatory examples are listed for Australia (TGA), the European Union (EU), the UK (MHRA) and the USA (TGA).
Disclaimer: This training course on clinical trials is for educational purposes only.
Licencing and permit data for a clinical trial researching outcomes of pharmaceutical cannabis treatments (medical marijuana) is also subject to change in the rapidly evolving medical cannabis sector. (C) All rights are reserved.
What you’ll learn in the Medicinal Cannabis Clinical Trials online learning module.
Clinical trial designs
How does the clinical trial sponsor (licence holder, importer or pharmaceutical manufacturer of medical cannabis in Australia), go about conducting a clinical trial?
- There are two potential regulatory pathways in Australia to conduct a clinical trial using medicinal cannabis.
- These are the Clinical Trial Notification (CTN) and the Clinical Trial Exemption (CTX) scheme.
CTN vs CTX Schemes – Medicinal Cannabis, HREC and the TGA
The most commonly used scheme for clinical trials for investigating cannabis medicines is the CTN. With the CTN scheme, the clinical trial Sponsor notifies the TGA of its intention to conduct a clinical trial after the trial is first approved by the relevant Human Research Ethics Committee (HREC).
This scheme is a unique regulatory mechanism available in Australia, as the TGA is not involved in reviewing and evaluating the safety of the tested product in clinical trials.
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FDA and EU approvals for clinical trials of medicinal cannabis products
In contrast, for medicinal cannabis clinical trials being administered in Europe or the United States, pre-clinical trial approvals are required from BOTH the relevant Regulatory Authority AND an Ethics Committee.
Clinical trial documentation requirements
- Documentation requirements for review and approval of medicinal cannabis clinical trials also differ between countries and regions
- However, there are many similarities in submission requirements for clinical trials using new cannabis products
Read more on best practices for record-keeping (Good Documentation Practice or GDocP).
Licences and permits to conduct medicinal cannabis clinical trials
- Because medicinal cannabis products involve controlled substances, depending on the region, additional cannabis licences and permits may also be required.
- These approvals must be gained to be able to obtain, and/or store and distribute, medicinal cannabis products to be used in the clinical trial.
Medicinal Cannabis Clinical Trial Design Considerations
Clinical trial designs/considerations for research involving investigational medicinal cannabis products will need to address the following:
- Inclusion and exclusion criteria of volunteers for medicinal cannabis clinical trials
- Dose/formulation of the product
- Volunteers confinement and monitoring requirements
- Secure storage of the medicinal cannabis products
- Supply chains
- Records on transactions, disposal and/or destruction of the investigational medicinal cannabis product
- Trial endpoints and justification for proposed product and dosing regimes
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This course is ideal for professionals who will work in clinical research roles involving investigational medicinal cannabis products, and for manufacturers or cannabis supply groups considering supplying cannabis for use in clinical trials.
The online training courses for medicinal cannabis cultivation are at the links below, and are a great resource for business owners, cannabis industry investors, cannabis clinical researchers, botanists, and clinical trial cannabis suppliers.
Medicinal Cannabis Cultivation training
- Medicinal Cannabis Industry training courses – Series 1 – MCCA101-106
- Medicinal Cannabis Industry training courses – Series 2 – MCCA107-112
Clinical Trials for medicinal cannabis (you’re on the right page – scroll up to order by ‘adding to cart’)
Pharmacovigilance of clinical trials – coming soon to our online GMP compliance training courses page (Certificate GMP courses)