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RD-210 — Research & Development Compliance
Ethics, data integrity, and regulatory pathways for compliant cannabis-related research across academic, clinical, and product-development settings.
At-a-Glance
| Item | Details |
|---|---|
| Module Code | RD-210 |
| Title | Research & Development Compliance |
| Duration & Modality |
12 hours total — 100% online: 8h e-learning + 4h virtual workshop (live). Delivery: LMS + interactive webinar (recordings provided). |
| Prerequisites |
CC-101 (Cannabis Law & Compliance) recommended. Background in life sciences or related fields preferred (not mandatory). |
| Certificate Awarded | “R&D Ethics & Compliance” (validity: 2 years) |
| Target Audience | Academic researchers • Private-sector R&D teams • Universities & labs • Product developers seeking a CLA/NCRC Research License |
| Individual Fee |
XCD $780 per learner. Group rates available for universities, labs, and companies. A portion of each enrollment is remitted to the NCRC. Credit policy: Fee is fully credited toward CannLab or CannCare program tuition if enrolled within 12 months. |
Learning Outcomes
- Understand ethical principles for cannabis-related research (informed consent, risk/benefit, vulnerable populations).
- Apply data-integrity standards (GCP, GLP, ALCOA/ALCOA+, record-keeping, reproducibility).
- Design compliant protocols aligned with CLA/NCRC and international norms (Declaration of Helsinki, ICH-GCP).
- Identify regulatory pathways for preclinical, clinical, and product-development research.
- Meet requirements for secure handling, storage, and reporting of research samples.
Detailed Content
- Research ethics foundations: autonomy, beneficence, justice; informed consent frameworks.
- Protocol design: endpoints, risk mitigation, DSMB/oversight, inclusion/exclusion criteria.
- Data integrity: GCP/GLP principles, audit trails, ALCOA/ALCOA+, change control.
- Sample governance: chain-of-custody, blinding/randomization, secure storage & disposal.
- Privacy & confidentiality: de-identification, data sharing, cross-border transfers.
- Regulatory landscape: CLA/NCRC submissions, IRB/REC approvals, safety reporting (SAE/SUSAR).
- Preclinical to clinical pathway: toxicology, Phase I–III considerations, post-market surveillance.
- Device/formulation studies: stability, validation, method qualification, documentation.
- Quality management: CAPA, deviations, non-conformance, inspection readiness.
- Publication & transparency: trial registration, authorship ethics, conflict-of-interest.
Assessment
- Online quiz: 30 questions (mixed formats).
- Protocol assignment: 2–3 page research protocol draft including ethics/consent and a data-management plan.
Recognized by Industry & Government
CaribCanna – The Caribbean Academy of Cannabis Sciences – is the recognized training provider accredited to deliver the mandatory Licensing Programs in Dominica.
