For Study Team
Use the links below for information on initiating a study with IDS, obtaining study drug doses during a patient visit, receiving IDS documents and guidance on monitor visits.
The Investigational Drug Service (IDS) is an integral part of clinical research at Emory University. IDS supports all Emory investigators in the conduct of industry and federally funded drug studies, and also provides support for many investigator-initiated studies.
University policy requires that investigators who conduct drug studies use IDS for the management and dispensing of research drugs. The policy applies to all investigational drugs as well as marketed drugs that are provided free of charge and used in clinical trials.
IDS has processes in place to ensure that study drugs are managed safely, accurately and effectively and that all accountability records are available for review by sponsors and auditors. Since 2007, IDS has used Vestigo, protocol management software, for all drug accountability, and IDS routinely provides access to sponsors and auditors for inventory review.
All drug studies reviewed by Emory University’s Office of Clinical Research (OCR) are submitted to IDS for protocol review and budget completion. IDS submits a budget, as requested, to OCR for inclusion in the overall study budget. IDS also completes a datasheet for all study drugs and submits the datasheet to OCR for inclusion in the Clinical Trials Packet.
Studies that are not reviewed by OCR should be submitted directly to IDS from the study team for review and budget completion @ ids@emory.edu.
Following IRB approval, the sponsor ships study drug directly to the correct IDS location. Once received, IDS reviews the inventory and sets up the new study in Vestigo. If the study requires that IDS obtain local supplies of study drug, IDS purchases the drug from the local wholesaler and directly bills the grant.
If the study is a Winship study, the drug orderset is created by the Winship Orders Committee and uploaded to ONCORE. If the study is a non-Winship study, IDS creates an order and submits the pdf to the study team.
While setting up the study, IDS obtains the SK# from ERMS and establishes billing based on the original budget. Vestigo then generates monthly invoices which are submitted through COMPASS to directly bill the study grant.
If a sponsored study utilizes an IXRS system for protocol management, IDS obtains access to the system, receives shipments and notifies the system of drug receipt.
If a study is managed by IXRS, research coordinators enroll patients in the system, register study visits and obtain study drug assignments to submit to IDS with the drug order. If a study is not managed by an IXRS system, IDS orders study drug from the sponsor or local wholesaler and maintains supplies in Vestigo.
To obtain study drug during an initial patient visit, the research coordinator submits a prescription signed by an authorized prescriber, along with the signature page of the consent, the ERMS enrollment form and any other supporting documentation such as IXRS assignments. IDS will not dispense the initial supply without the signed consent. For subsequent dosing, IDS requires a signed order and the IXRS inventory assignment, if applicable. All orders are submitted via efax to 404 727-0265 or via email to idsfax@emory.edu.
The research coordinator registers and maintains study visits in IXRS systems and enters patient returned inventory for oral drug studies for the majority of studies. For studies that are blinded and IDS is the unblinded third party, IDS maintains all inventory entries in IXRS to maintain the blind.
If study drug needs to be shipped to a patients’ home, IDS requires that the research coordinator obtain approval from the sponsor and submit the request to ship with the prescription as follows: Shipping to patients’ homes information
For studies involving oral outpatient drugs, returns from patients should be delivered to IDS for review and processing.
IDS routinely allows monitor review of pharmacy study records through Vestigo access. Prior to COVID-19, IDS conducted onsite visits on a daily basis. With the onset of COVID-19, IDS shifted to remote monitoring with extended access to Vestigo and the capability of conducting Webex reviews of existing inventory. For the near future, IDS plans to continue with remote monitoring.
Monitors can use the IDS calendar to schedule time with IDS. For site qualification visits (SQV) and site initiation visits (SIV), IDS is available to conduct meetings with sponsors via Zoom or Webex. For routine monitoring visits and closeout visits, IDS will continue providing access to Vestigo all day on the date selected by each monitor. IDS staff review the calendar daily and interact with monitors to insure availability of requested documentation for each monitor visit.
Below are links to IDS documents that you can email to sponsors, if requested
- The IDS Summary for Sponsors provides an overview of the IDS operation and is pertinent at the time of an SQV or SIV.
- The Blinding Plan is a summary of IDS procedures to insure that the blind is maintained on studies in which IDS is unblinded.
IDS has a certified compounding pharmacist on staff to compound capsules for investigator-initiated double-blind studies. All capsules are compounded according to USP795 requirements for nonsterile compounding. For guidance on capsule compounding or an estimate for capsule compounding, please contact cathy.crowley@emory.edu.
IDS contracts with Apple Courier to provide courier services to EUHM, Executive Park, ESJH and other locations in the Emory system. Each day, IDS schedules drivers to deliver prepared doses to patients enrolled in clinical trials and has two drivers available to insure timely deliveries.
