Investigational New Drug (IND)

Out of date information:

For REW22 and the Trauma grant, we use a drug called Amisulpride which is not FDA approved in the US. Because of this, we have an IND from the FDA that allows us to use the drug. Both of these studies are covered under the same IND. Information on the IND is located at: common\Reg_Binders\Shared\Drug_and_Safety_documentation\IND_107564_Amisulpride

• There are two main forms that we have for the IND: the 1571 (application) and the 1572 (for study staff)
• For any amendment and annual report, you will need to submit the 1571. Track the number of the application through the serial number section on the IND.
• At the anniversary of the IND approval, you need to submit an annual review of the study protocol. This will include a progress report, and a cover letter, and also the drug information
• During the annual review, you can also submit any changes to the protocol, and changes in study staff
• You mail hard copies of the review to the FDA. You will not hear back about the review unless something is wrong with it.
• To find the questions you need to answer on the annual review, copy and paste from the previous year review

Pharmacy

Find additional information at common\admin\pharmacy. The process for amisulpride order/supply is subject to change. Be sure to always check with Laura Godfrey.

Setting up a study with the Pharmacy

• When you are designing a study for the first time (in the protocol writing stage) you should contact the research pharmacy to discuss study design and manufacturing the drug. Laura Godfrey x2777 is who you want to be in touch with. She only works M-Th in the mornings.
• She will then start the process and will review the protocol, and then set up a meeting with you and the PI to discuss specifics on the randomization and the manufacturing.
• She will be able to provide you prices for services as well
• Laura will make an order form for the study which we will fill-out, have signed by the study doctor, and then bring to the pharmacy. Of note, Laura generally needs 1 week notice for dispensing (organizing pills and putting in blister packs) and 1 month notice to make a supply of pills.
• Laura needs a signed letter from Diego authorizing her to dispense the drug for and also noting who is authorized to pick up the study drug. RAs can be authorized for this.

Ordering new drug for a study

• Plan ahead! One month notice is required for the manufacturing of new pills and one week is required for dispensing new blister packs
• During the study, the randomized drug will expire and you will have to order new drug.
• You do this through the pharmacy order form, also email Laura to let her know you will be coming by. Remember, Laura is only in Monday-Thursday in the mornings.
• Note which subject number you would like the new drug to start on, and how many pills you would like.
• You will need to have the study doctor sign the form and then you will need to drop the form at the pharmacy

What happens if a participant takes a pill but does not complete the scan?

(e.g., subject discomfort/claustrophobia, adverse event, scanner malfunction)

• Alert Laura, she will move this participant’s randomization code to the bottom of the group’s list
• If the subject is re-scheduled, use the next pill/randomization for him/her