Investigational Drug Services (IDS)
The investigational pharmacy at VCU Health provides services to clinical studies that include investigational medications. IDS offers a wide menu of services, such as inventory control, storage, accountability, packaging, labeling, preparation of medications, sterile and non-sterile compounding, hazardous compounding, blinding plans and randomization. IDS is also able to provide services for after-hours enrollment if study logistics permit; this need must be communicated during set up so that IDS can review for feasibility and draft charge estimates appropriately.
IDS has extensive experience in complying with applicable government regulations, accreditation standards of the Joint Commission and the Association for the Accreditation of Human Research Protection Programs, and institutional policies for investigational drug control. Utilization of IDS for investigational drug control aids principal investigators in protecting human research subjects through improved drug security, safety and accountability. The VCU Institutional Review Board (IRB) requires use of the IDS pharmacy for studies which utilize investigational drugs and/or biologics, regardless of whether the study involves inpatient or outpatient visits. There may be minor exceptions to this requirement if using IDS is not logistically feasible, such as at off-site locations where IDS are unavailable. For such scenarios, a drug management plan (DMP) must be submitted for IDS approval and that approval must be forwarded to the IRB. The IRB will not approve a protocol requiring a DMP without verification that IDS has approved the plan. All VCU studies involving human use of an investigational drug, including drugs used at off-site locations and drugs used through emergency use, compassionate use, or expanded/managed access pathways, must be submitted to IDS for review by using the new study intake form. See internal guidance documents below for additional information on individual or multiple patient access investigational drug use.
Remote monitoring
Currently, IDS is only allowing remote monitoring access via Vestigo. Vestigo is the electronic accountability platform IDS uses to track, dispense and bill for investigational medications. Additionally, we have all SOPs, temperature records, and calibration certificates posted in Vestigo. Monitors can request remote visit appointments within Vestigo. To grant Vestigo access, IDS requires monitors complete and email the Vestigo e-signature form to investigational.drug@vcuhealth.org. Once the form is received, IDS will associate the monitor with the protocol in Vestigo, which allows future self-requesting of remote appointments. See the Vestigo resource document for details regarding the Vestigo remote visit appointment request process.
Pharmacy locations, hours and shipping addresses
- Key information guide: details including pharmacy locations, hours, shipping addresses and contact information
- Observed holidays memo: pharmacy closures
Emergency use and expanded access assistance
- Internal guidance for expanded access in intermediate-size patient populations or widespread treatment use
- Internal guidance for individual patient expanded access investigational drug use
For more internal resources related to IDS and how to contact IDS after hours, please refer to the VCU Health IDS intranet webpage (VCU Health credentials are required to log in).
Pharmacy virtual tours
Main IDS
AOP IDS