Sponsors
Resources available to study monitors, auditors or other sponsor representatives are presented below. Use the links to obtain information about IDS services, sponsor-specific documents or to schedule a visit with IDS.
The Investigational Drug Service (IDS) is an integral component of clinical research at Emory. IDS manages all investigational drug studies conducted by Emory investigators, ensuring that study subjects receive protocol-specific dosing as they participate in clinical trials, and that research drugs are handled safely and effectively.
IDS has systems and procedures in place to meet requirements of sponsors, the FDA, Georgia Board of Pharmacy and other regulatory agencies. Systems include Vestigo for protocol management, patient enrollment and drug accountability, VIZZIA for temperature monitoring and control, and PharmacyKeeper for IV compounding documentation. IDS maintains a USP797 cleanroom for compounding nonhazardous IV drugs, and a USP800 cleanroom for compounding hazardous IV drugs. In addition, all hazardous drugs are stored in a separate USP800 storage room.
IDS has transitioned to a completely paperless system, and all protocol-specific pharmacy documentation is maintained electronically in Vestigo. This allows for remote review by monitors who are routinely given Vestigo access to review pharmacy records.
In 2007, IDS was one of the first sites to purchase WebIDS which later became Vestigo. Vestigo is now the standard for protocol management by IDS operations around the country, and has contributed to the rapid and sustained growth of the Emory IDS operation. All pharmacy records, including drug accountability, shipping and temperature monitoring documentation, correspondence, protocols, pharmacy manuals and training documentation are maintained in Vestigo for monitors to review.
Vestigo has established the VestigoVerify module for monitors to review IDS study documents. IDS builds a profile for each monitor in Vestigo and provides access to studies at the time of monitor visits. Each time IDS provides access, the monitor receives an email from Vestigo with login information.
Once access is granted, the monitor can review the following by clicking on the “View Protocol link” to the right of the visit notification:
- Protocol – protocol overview
- Inventory – overall inventory and add visit notes if needed
- Returns – patient returns and authorize destruction or return to sponsor
- Documents – shipping invoices, protocols, pharmacy manuals, training documentation, correspondence from sponsor
- Accountability – obtain accountability logs (IDARs)
- Visit Notes – add notes specific to the visit
- Monitor Review – review transactions related to each drug item
- Audit Log – IDS audit trail for review
- Temperature documents – Temperature logs and calibration certificates for each drug storage location
- Reports – protocol-specific reports available for monitor review
Following review of Vestigo, email IDS if more time is needed in the system or if there are any questions @ dolores.anderson@emory.edu.
The Emory IDS system is paperless, and all protocol-specific documents are available in Vestigo. For this reason, the majority of monitor visits can be conducted remotely.
IDS has always asked monitors to schedule visits according to their schedule. To accommodate scheduling, IDS has maintained a calendar for monitors on the IDS webpage (Monitor Calendar).
In an effort to streamline the scheduling process, IDS has begun to offer monitor scheduling through Vestigo, and effective January 1, 2024, IDS will require monitors to schedule through Vestigo. IDS staff set availability for monitor visits on the Vestigo calendar, and monitors can request a visit through the Vestigo Verify portal.
The capacity for onsite visits is limited, but monitors can request an onsite visit, and IDS staff will determine if a visit can be scheduled. Please email Dee Anderson, Pharmacy Technician III, at dolores.anderson@emory.edu for general questions about scheduling or for onsite visits.
IDS ensures that research drugs are stored securely, and that temperature is monitored and documented in all drug storage areas. IDS uses an electronic system, VIZZIA, for temperature monitoring and maintains all temperature logs and calibration certificates in Vestigo for sponsor review.
A VIZZIA temperature monitoring probe is maintained in each drug storage area. The probe records temperatures every 15 minutes for each storage area and presents the data in a report format. Temperature probes are calibrated annually. IDS maintains temperature logs and calibration certificates in Vestigo, and monitors can review the protocol-specific logs and certificates under the Temperature Documents tab through VestigoVerify.
IDS also maintains a backup manual system which includes a daily check of digital thermometers located in all drug storage areas. All temperatures are recorded in SIMPLIFI where reports can be generated for each storage location.
In 2021, IDS implemented PharmacyKeeper, a photo-based medication system that allows documentation of IV compounding. IDS technicians take images of the setup and final product for each dose, documenting the volume of drug and diluent as well as supplies used to compound. Pharmacists verify the dose and save the image by the Rx# listed in Vestigo. Specific images can be pulled on demand if needed for review.
