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Investigational Drug Supply Form
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Contact Information
Sponsor Organization
Sponsor Email
Lead Contact
Lead Contact Phone
Principal Investigator Contact Information
Principal Investigator Name
Principal Investigator Email
Street Address
City
State/Province/Region
Zip/Postal Code
Country
Institution Information
Institution Name
Phone
Street Address
City
State/Province/Region
Zip/Postal Code
Country
Study Information
Study Title
Study Phase
Preclinical
Clinical
Study Type
Investigator Initiated
Commercial
Investigator Initiated with Commercial Funding
Clinical Phase
If applicable
Funding Sources
Indication
Anticipated Start Date
Regulatory Submission Type
Research
Commercial
Study Design
Open-label
Single-blind
Double-blind
Filing under which regulatory agency?
(ex: FDA, EMA)
Do you intend to publish your study results?
Yes
No
Anticipated Investigational Drug and Material Needs - Capsules
5mg Capsule Psilocybin (cGMP)
Number of capsules
25mg Capsule Psilocybin (cGMP)
Number of capsules
100mg Capsule Niacin (cGMP)
Number of capsules
25mg Capsule MCC Inert Placebo
Number of capsules
Anticipated Investigational Drug and Material Needs - Bulk
Bulk Psilocybin (cGMP)
Quantity
Bulk Psilocybin (cGMP)
Unit
mg
g
Bulk Psilocybin (non-cGMP)
Quantity
Bulk Psilocybin (non-cGMP)
Unit
mg
g
Requesting unlisted drug
If requesting an investigational drug or material not listed, please identify the material, quantity, and intended purpose
Material Shipping
Do you plan to utilize a distributor for shipment of product?
Yes
No
Product Labeling
Are there any country-specific or unique product labeling requirements that you are aware of?
File Upload
We require a summary of your study to proceed. Please submit your study summary here. Max. file size: 5 MB, Max. files: 10.
Drag and drop files here or click to upload
Supporting documentation types
Select the types of any additional supporting documents your are uploading. This additional documentation is not required at the time of request but may be submitted for review.
Final, IRB approved protocol
Copy of the Informed Consent Form
IRB Approval Letter
Appropriate Controlled Substances Licensure for study site
Appropriate Controlled Substances Licensure for shipping site (if different from study site)
Copy of regulatory approval to proceed with clinical trial
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