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2.0.0 CMAP™ Checklist:
for Cannabis Research in Human Subjects (Appendix A)

2.1.0 Purpose of the Study Exploratory To prove a hypothesis

2.2.0 Sponsor Institution Private study Not indicated

2.3.0 Bias Sources of funding National Institutes of Health (NIH) National Institute of Drug Abuse Pharmaceutical company Private funding and organizations Not for profit Other: Affiliations academic commercial non-profit governmental Potential undisclosed bias based on: personal public statements interpretation and conclusions of published and unpublished studies sources of funding professional or academic affiliations

2.4.0 Institutional Review Board (IRB) approval IRB run by the organization (academic or commercial) conducting independent research IRB run by a company in the business of providing independent IRB services

2.5.0 Abstract

2.6.0 Protocol

2.7.0 Methodology

2.7.1 Subject Selection Sampling technique Controlled sampling Subjects randomly assigned to a control or test group Subjects self-selected Single-blind Double-blind Exclusionary criteria in sampling age gender ethnicity use or history of use of prescription drugs over the counter drugs recreational drugs tobacco nicotine vape (see Method of Administration, Sections and nicotine transdermal patch alcohol other exclusionary criteria Psychophysiological considerations Set mental state expectation effect double blind Setting physical environment social environment double blind Examples: informal by subject’s choice formal by protocol “mood” of the setting experience (history of cannabis use) subject’s circadian rhythm other herbal supplements, over-the-counter and prescription drugs) other active and “inert” ingredients in topicals, et al.    New cultivar effect    Typical rotation/use sequence of cultivar re tolerance not just to THC, but “entourage” or “integration” effect as well

2.7.2 Cannabis Selection Plant Profile Botanical identification (Cannabis Sativa L.) Hybrids – bred into thousands of cultivars from variations grown from these 4 sub-species) Sativa Indica Ruderalis Afghanica Cultivar name (e.g., “Super Lemon Haze”) Cultivar’s genetic lineage: (e.g., Lemon Skunk x Super Silver Haze) validation of cultivar Characterization of effects of cultivar studied Cultivation Growth conditions Grower-producer Phenotype seed genetics verified genetics not verified clone genetics verified genetics not verified indoor type of lighting LEDs (specific spectrum) high pressure sodium (HPS) metal halide (MH) outdoor sungrown greenhouse hydroponic soil nutrients water quality tap water alkaline/ph balance bottled hard soft organic not organic pesticides used wash-out period (flush) Living Plant Testing Harvest harvest time readiness of trichomes days into flowering time of day of actual harvest Testing at harvest Post-harvest Fresh raw cooked Trim Drying moisture content Cure testing Storage oxygen light heat time humidity biological sterilty Processing Whole Plant Flower Trim Extraction Solvent CO2 ice water butane purge type of purge test of purge results Solution for extraction of fat soluble molecules butter, oil, or fats plant saturated unsaturated animal saturated unsaturated food grade ethanol alcohol content/evaporated alcohol content/not evaporated food grade glycerin glycemic load food grade propylene glycol Laboratory Analysis Cannabinoid profile (partial) – see Glossary and Other Resources, Section   CBG-A (Cannabigerol-acid)   CBG    (Cannabigerol)   THC-A (tetrahydrocannabinol-acid)   THC (tetrahydrocannabinol, THC, Δ9 , Delta-9- after decarboxylation)   THC 11 (tetrahydrocannabinol – 11)   THCV (Tetrahydrocannabivarin)   CBD-A (Cannabidiol)   CBD (Cannabidiol – after decarboxylation)   CBC-A (Cannabichromene-acid) CBC (Cannabichromene – after decarboxylation) CBN-A (Cannabinol-acid) CBN (Cannabinol – primarily found as a result of THC breakdown during storage, not from CBN-A oxidation) Other cannabinoids Terpene profile (partial)  There are more than 100 terpenes with a range of effects — many well studied in other plants; they are a major driver of the “entourage effect” and many terpenes cross the blood-brain barrier.  The following list includes some of the major terpenes, other plants in which they are found, and some of their reported effects. Monoterpenoids (highly volatile and likely to be lost or diminished during drying and early storage)   Borneol (camphor, rosemary, and mint) – anesthetic, anti-inflammatory, analgesic   Cineole (eucalyptus) – analgesic for topical uses, stimulant   cis-Ocimene (variety of plants and fruit) – used in perfumery   Limonene (orange peel) – hypothermogenic   Linalool (lavender) – relaxant, anesthetic, anti-convulsant, analgesic, anxiolytic, burn therapeutic agent, anti-depressant (via seratonin-receptor transmission amplification)   Myrcene (hops) – sedative for sleepiness, analgesic, muscle relaxant   a-Pinene (pine) – bronchodilator, memory retention aid, anti-bacterial, anti-inflammatory; crosses the blood-brain barrier easily.   Pulegone (rosemary) – may prevent short-term memory loss (acetylcholinesterase protein inhibitor)   Terpinolene (cumin, lilac, apple, tea-tree and conifers) – anti-septic, anti-bacterial, anti-fungal, preservative, treats insomnia in a blend of lilac and lavender. Terpineol (lilac, apple blossoms) – used in perfumes, cosmetics, and flavorings. Others Sesquiterpenoids (less volatile) a-Caryophyllene or Humulene (hops, pine) – anti-inflammatory b-Caryophyllene (black pepper) – anti-inflammatory, analgesic, protects cells lining the digestive tract, binds to CB2 receptors Caryophyllene oxide (oxidated Caryophylene) – anti-fungal, anti-bacterial b-Eudesmol (Chinese herb) – anti-convulsive trans-Nerolidol (ginger, jasmine, lavender, tea tree, lemon grass) – flavoring, perfumery, and may enhance skin penetration for transdermal delivery of therapeutic drugs Other Cannabis Terpenes Flavinoid profile Flavones Flavanols Vanilloid profile Vanilloids Contaminants Lab QA Program and Testing (per Washington State Liquor Control Board – WSLCB)
Washington State Liquor Control Board (to become WS Liquor and Cannabis Control Board), WAC 314-55-103 “Good Laboratory Practice Checklist.” (for certification of I-502 products), PDF, pp 7-9. Sampling/sample protocols adequate chain of custody tracking sample preparation, extraction and dilution (SOP) demonstration of recovery for samples in various matrices (SOP): plant material/flower edibles (solid and liquid meant to be consumed orally) topicals concentrates tincture spray Whole plant sampling method (cannabis selection) Location of sample Specific location (bud, leaves, high, low) Several locations averaged Homogenization Weighing Labeling Sample identifier (source, lot) Date Tracking Condition of sample macroscopic inspection foreign matter microscopic inspection microbial contaminants nutrients and fertilizers pesticides moisture analysis residual solvent metabolite analysis beginning of testing during testing end of testing sample potency beginning of testing during testing end of testing chemical assay procedure/method method LC HPLC uHPLC (aka UPLC) GC Headspace GC next generation advances data protocols followed Calculations for quantification of bioactive compound content in various matrices – SOPs Determination of the range for reporting the quantity (LOD/LOQ) data review or generation Reporting of data: certificates of analysis (CA-clear and standardized format Documentation that value reported in CA is within range/limits of the analytical method Documentation that qualitative results (below LOQ but above LOD) are reported as “trace” Documentation that method has specificity for degree of quantitation reported Use of appropriate controls: Documentatoin of daily use of positive and neg controls that Level II validation of methodology used for quantification of bioactive compounds single lab validation parameters are demonstrated for GC, HPLC data review:* linearity of reference standards use of daily standard curve accuracy precision recovery (5 determinations not less than 90%) reproducibility over time within a relative standard deviation of 5%

2.7.3 Methods of Extraction (MOE); Method of Administration (MOA); Timing of Administration (TOA)

Note: Cannabis may be pre-activated (heated) or cold-extracted and activated during consumption Heated plant – heated sufficiently to activate cannabinoids (decarboxylated) examples: combust, vape, dab, edible, tincture Partially heated plant – not heated sufficiently to activate (tincture, other low temperature extracts) Raw Plant examples: juicing, fresh greens in salad Extracts/Concentrates
solvent (if any) may be pharmaceutical grade (PH), food grade (F), Commercial ( C), Industrial (I), organic (O), plant-based (PL), or animal-based (A) kief – solventless mechanical extraction hash – solventless, ice water, mechanical extraction hash oil – solvent extraction butane CO2 fats/oils alcohol/ethanol Ingredients in Edibles and other MOAs
Note: pharmaceutical grade (PH), food grade (F), Commercial ( C), Industrial (I), organic (O), plant-based (PL), or animal-based (A) fats (butter, oil, etc.) alcohol/ethanol (e.g., Everclear) propylene glycol glycerin Bio-Pharma Pharmaceutical extracts (e.g., Sativex) Synthesized Cannabinoids (e.g., WIN-55) Inhalation Oral inhalation Flowers (aka “bud”), hash, or other concentrates are combusted or vaporized (aka “vaped”) to decarboxylate (activate) with heat during consumption Oils can also be pre-decarboxylated (activated) and delivered as a mist from a heated atomizer (vape pen) Oral/heated and nasal/unheated combined inhalation
(e.g., Terpz inhalation system) Oral or nasal inhalation of terpenes oral nasal Edibles – Infused Products
(Note: may be pre-activated (A), heated before consumption; or inactive (I)
) Raw plant edible juiced salad greens fresh (same day harvest) storage period Food and drinks infused liquids infused solids Capsule or pill Sublingual Spray Tincture Candy Topical oil lotion cream spray (e.g., for topical relief of neuropathy, arthritis) Transdermal patch Vaginal suppository Rectal suppository Intravenous injection Timing of Administration time-released capsule or caplet when administered same time each day in circadian rhythm with meal before meal after meal interaction with other medicines and supplements interaction with types of food and drink MOA, MOE, and TOA are matched to subject’s medical condition and purpose of study Method of Administration Method of Extraction Timing of Administration

2.7.4 Data collection and metrics (examples): Qualitative data Self-reporting survey (with open-ended questions) In-depth subject interviews Field research Search of relevant anecdotal literature Quantitative data Self-reporting survey (with quantitative questions) Physician reporting Medical records search Data analysis from other studies Epidemiological Meta-analysis Search of relevant peer-reviewed published studies Serum metabolites measured

2.8.0 Data analysis

2.8.1 Qualitative Data
2.8.2 Quantitative Data
2.8.3 Statistical analysis
2.8.3. Common statistical tests and procedures (per Wiki) include: Analysis of variance (ANOVA) Chi-squared test Correlation Factor analysis Mann–Whitney U Mean square weighted deviation (MSWD) Pearson product-moment correlation coefficient Regression analysis Spearman’s rank correlation coefficient Student’s t-test Time series analysis

2.9.0 Discussion
2.9.1 Discussion should reflect an understanding of the complexities of cannabis research

2.10.0 Findings
2.10.1 Findings noted should be supported by the data

2.11.0 Interpretation
2.11.1 Interpretation should be supported by the data

2.12.0 Conclusion
2.12.1 Conclusions should be supported by the data


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