FAQs
General Information
Do I need to use IDS for my med-related protocol
Any agent or drug (potentially including supplements) used on the study could be considered investigational, and will therefore require IDS services. If the drug is the primary intervention and its efficacy or safety is being studied, it will be considered investigational. If an IND is required, it is classified as investigational. If an IND is not required, it could still be considered investigational and will be decided on a case by case basis. If you are unsure if your med-related protocol is investigational, please reach out to us at uncids@unchealth.unc.edu.
How do I initiate a request for IDS services?
Utilizing the Clinical Research Management System (CRMS), submit a request for IDS services. The embedded worksheet will estimate the complexity of the protocol and estimate the billing. The IDS team will review and send a confirmation memo.
When should I request for IDS services?
Request for IDS services in CRMS should be submitted simultaneously with contract negotiation (OCT) and request for IRB approval, or earlier.
When should I request assignment of an IDS pharmacist?
As soon as you know the trial will move forward to opening and enrollment, submit a request for a pharmacist assignment. The request for a pharmacist is the signal to IDS that your study will be moving forward. This triggers a specific pharmacist to be assigned to work up the protocol and get it ready for dispensing out of IDS. Once a pharmacist is requested, we will have the study ready to dispense from IDS in 6 to 8 weeks.
What services does UNC Health IDS offer?
All IDS staff will be involved in dispensing investigational product, managing inventory, monitoring storage and temperature conditions, maintaining accountability and data records through Vestigo, receiving monitor visits and audits, and responding to questions from study teams and sponsors.
What services do Lead Pharmacists provide?
Each protocol is assigned a lead pharmacist to be the primary driver of the protocol in IDS. The lead pharmacist will be responsible to work up new protocols to distill pharmacy processes, create information sheets for every protocol, train IDS staff and ancillary pharmacy staff as needed on new protocols, revise protocols as required by amendments or study updates, and communicate with study teams regarding protocols
How are Investigational Products (IP) dispensed?
A valid order (either paper or Epic order entry) must be received by IDS. if utilizing a paper prescription, IDS needs the original signed prescription before dispensing. The IP must be picked up from IDS on the same day as the patient visit, unless otherwise arranged in advance (contact IDS if you wish to pursue this). Verbal notification is not sufficient for dispensing to begin.
After-Hours
If there is an emergency outside of normal business hours, how do I get into contact with an IDS pharmacist?
The IDS pharmacist on-call can be paged at 919-216-9727. They can also be paged through WebExchange at “INVESTIGATIONAL DRUG SERVICE ON CALL”
What can the on-call IDS pharmacist help out with outside of normal business hours?
The on-call IDS pharmacist can assist with individual drug or research questions, the breaking of a treatment blind, and provide support for inpatient or IV room pharmacy staff who may be unfamiliar with a particular research protocol
Does IDS dispense after-hours?
Yes. If a research protocol requires after-hour dispensing, this must be arranged prior to opening a trial to enrollment. After-hours dispensing will increase complexity score, may lead to higher fees, and may lengthen the time it takes to open the trial with IDS.
Compounding
Can non-sterile products be compounded by IDS?
IDS can do minimal compounding for blinding solid oral dosage forms. More complex compounding such as mixing powders, filing capsules with powders, creating suspensions, and creating creams cannot, in the most cases, be done by IDS. If you wish to inquire about IDS creating a non-sterile compounded product, please reach out to us at uncids@unchealth.unc.edu