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

Bulk Psilocybin (non-cGMP)

Quantity

Bulk Psilocybin (non-cGMP)

Unit

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

Investigational Drug Supply Form

Contact Information

Principal Investigator Contact Information

Institution Information

Study Information

Anticipated Investigational Drug and Material Needs - Capsules

Anticipated Investigational Drug and Material Needs - Bulk

Material Shipping