Steps to getting started
link to CHIRP research protocol template- coming soon!
- Study team members need to complete Good Clinical Practice training
- What training for Psychedelic Assisted Therapy (PAT) does your team require?
- link to PAT resources- coming soon!
- List all critical steps for each part of the study
- Create Case Report Forms (CRFs) for each study visit
- CRFs specifically for research using psychedelics- coming soon!
- Create a REDCap project, if using, to store study data
- REDCap data dictionary for research using psychedelics- coming soon!
Learn more about IRB submissions by visiting the WashU Human Research Protection Office
Every researcher conducting research with Schedule 1 controlled substances much obtain a Research License with the DEA and the Bureau of Narcotics and Dangerous Drugs (BNDD). It takes only a few minutes to apply, but can take 4-6 weeks to receive the license, so plan ahead!
BNDD- Missouri
The BNDD registration must be approved prior to submitting the application to the DEA, and must be renewed annually.
To register for a Missouri BNDD:
DEA
DEA Form 223 is the researcher’s certificate of registration, and must be renewed annually.
- DEA Headquarters: 1-800-882-9539
- email the DEA at DEA.Registration.Help@dea.gov
To get a DEA Researcher License:
- NOTE: The person whose name is listed on the DEA license is legally responsible for all sites under that license number.
- NOTE: A separate registration must be obtained for each individual location where a controlled substance is stored, administered or dispensed.
DEA Application Checklist:
- Missouri State Research License to handle controlled substances
- Institutional authority to conduct research with Schedule 1 controlled substances
- Identify each study/project covered by the DEA application
- IRB approval letter for each study
- Submission of Notice of Claimed Investigational Exemption for a New Drug (IND)
- Study protocol
- CV for each investigator
- Statement of the security provisions for storing the controlled substances and for dispensing the controlled substances in accordance with 1301.75
example letter- coming soon!
Researchers apply for and must obtain an Investigational New Drug (IND) number prior to beginning research. The FDA must authorize a researcher to conduct research with an unapproved drug, or an approved drug being used for either a new indication or in a new patient population.
After submitting the IND application, researchers must wait 30 days before beginning the clinical trial allowing the FDA time to review the application.
The researcher will provide annual updates to the FDA. Additionally, the researcher must submit changes in the principal investigator or study protocol to the FDA.
Adverse events must be reported to the FDA through a safety report.
Helpful Links
- All studies, other than Phase 1 studies, that include a drug, device or biologic must report results of the trial on clinicaltrials.gov
- Results must be reported within 12 months of the primary completion date of the study. It is recommended that the PI or a statistician complete this task.