Research PharmacyDirector: Susan Goodin, Pharm.D. The Research Pharmacy Shared Resource provides support for CINJ members who conduct research with investigational agents, which includes all study agents used in human subjects. Objectives The overall goal of this shared resource is to support scientifically rigorous research by providing an efficient, centralized service of extraordinary quality to CINJ members. Additionally, the Research Pharmacy provides critically important services that ensure the quality and safety of human subjects research. The specific goals of this shared resource are:
Specific Services Preparation and Handling for all Investigational Agents: The Research Pharmacy developed methods for the preparation and delivery of investigational agents. Policies and procedures are in place that ensure:
Drug Accountability, Dosing, and Administration: Research Pharmacy reviews all protocols before submission to the UMDNJ Institutional Review Board (IRB) to ensure that drug accountability, preparation, dosing, and administration are clearly defined. This helps to minimize the risk of medication errors. Procurement: Research Pharmacy works with principal investigators and sponsoring organizations to coordinate the procurement of investigational drugs. Upon receipt of the investigational agent, all shipping documents are verified against materials received, lot numbers, and expiration dates. The Research Pharmacy also obtains, tracks, and supplies commercial agents for clinical trials and for in-vitro use by CINJ members. Storage and Security: The Research Pharmacy, wherein all investigational agents are stored, is double-locked at all times and is accessible only by Research Pharmacy staff. There is adequate room-temperature storage space, refrigeration, and freezers (a -30°C and a -86°C). Monitoring of these temperatures occurs hourly and is documented with Temp Trak™, a wireless remote temperature monitoring system with daily back up to the CINJ server. Additionally, the refrigerators and freezers are programmed to trigger a designee’s pager alarm if the temperature is out of range. Dispensing and Record Keeping: The Research Pharmacy ensures that all investigational agents are used in accordance with FDA and NCI guidelines for investigational drug use. Research Pharmacists directly oversee the handling of all investigational agents and ensure that preparation of agents is performed according to the respective protocol. The Research Pharmacy staff is responsible for verifying that all study agents are dispensed only for patients on IRB-approved clinical trials, that the most up-to-date informed consent is signed by both the patient and an approved investigator, that the patient is eligible, and that the patient has been enrolled by the OHRS. A chemotherapy order form, which includes the IRB protocol number, must be completed and signed by an approved investigator. All orders are cross-referenced to the protocol for verification of dosing and administration. The Phase I Group uses an integrated electronic medical ordering and medical record system. The Research Pharmacy provides further quality assurance by verifying that the medication orders translated into the system conform to those specified in the protocol Drug Accountability: Drug accountability is performed as outlined in the NCI Drug Accountability guidelines. Verification of inventory for quality assurance is performed monthly and each time a drug is dispensed by the Research Pharmacy. Monthly verification of inventory includes comparison of the quantity of investigational agents in stock compared to the quantity at the time of the last monthly verification, cross-checked with the amounts recorded on the Drug Accountability Forms. Each time a drug is dispensed, there is a check of the expiration date and a cross-check of the patient registration list with the Drug Accountability Forms to verify that patient initials and study numbers match, and to ensure that all patients scheduled to receive an investigational drug are registered on the protocol. For CINJOG trials conducted at affiliated institutions, the Research Pharmacy is responsible for training the staff and for inspecting the pharmacy at these sites. Patient enrollment is verified through the OHRS and a facsimile copy of the signed informed consent is forwarded to the Research Pharmacy. Investigational agents managed by the CINJ Research Pharmacy are distributed to these institutions as outlined in standard operating policies developed by this shared resource. CINJ investigational agents dispensed at Robert Wood Johnson University Hospital (RWJUH) are also under the direction of the CINJ Research Pharmacy. Pharmacists at RWJUH are in-serviced for each trial on drug accountability by a CINJ Research Pharmacist, and the Research Pharmacy performs monthly audits on active studies involving investigational/study agents. Adverse Event Report Filing: Reportable adverse events are defined for each clinical trial according to NCI recommended guidelines. The Research Pharmacy and the OHRS staff, in concert with the principal investigator, assist in the reporting of toxicities. A Research Nurse ensures that toxicities are documented in the clinical chart and that the Toxicity are included as part of the CINJ clinical research record. Expert Consultation for Clinical Trial Development: The Research Pharmacy provides expert consultation during the development of clinical trials. The staff focuses on the development of exclusion criteria for concomitant medications that may interact with the protocol agent, exclusion criteria for renal, pulmonary, liver or cardiac function based on the preclinical toxicity profile of a new agent for a phase I trial, and collaborate on the sequence of administration of protocol agents in the treatment plan. This shared resource takes part in the weekly Phase I Group weekly meetings, the OHRS weekly meetings, and in protocol activation meetings to continuously and prospectively address these issues. Drug Formulation: The Research Pharmacy has the capacity to formulate new agents including biologicals (e.g., fowlpox vaccines), natural products (e.g., croton oil), and foods (e.g. green tea lozenges). The staff work with members and sponsoring regulatory agencies to achieve approval of new formulations. IND Submissions: The Research Pharmacy works actively with CINJ investigators in the submission of IND applications. Quality Assurance: The Research Pharmacy staff are responsible for ensuring that all study agents are dispensed only for patients on IRB-approved clinical trials and only after the most recently IRB-approved consent form has been signed by both the patient and an approved investigator. The OHRS Regulatory Affairs Division provides the Research Pharmacy with copies of the most recent protocols, amendments, and consent forms. Investigators and research nurses obtain consent forms from the Research Pharmacy after signing, dating and noting the name of the patient being evaluated in the consent form log. This system provides a mechanism to track patients evaluated for each clinical trial. The Research Pharmacy verifies that a signed and dated consent form is in the chart, re-verifies patient eligibility and confirms with the OHRS that the patient is enrolled onto a study before dispensing a protocol agent. Additionally, a pharmacist obtains a comprehensive medication history from the patient to minimize the risk of drug interactions. For randomized investigator-initiated clinical trials, the Research Pharmacy obtains the randomization schema from the Biometrics Shared Resource. The Research Pharmacy performs the randomization and maintains the randomization codes for possible decoding in the event of a medical emergency. Contact: Director: Susan Goodin, Pharm.D.
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Shared Resources
Analytical Cytometry / Image Analysis Office of Human Research Services Centralized Education & Training Services Protein Structure Analysis and Modeling Pharmacokinetics / Pharmacodynamics New Jersey Family Medicine Research Network Survey Research and Qualitative Methods All the above Facilities are supported by CINJ’s Cancer Center Support Grant (CCSG)
Additional Shared Resources
Rutgers Center for Operations Research Rutgers University Cell & DNA Repository The Environmental and Occupational Health Sciences Institute (EOHSI) Center for Advanced Biotechnology and Medicine (CABM) Laboratory for Cancer Research Biotechnology Center for Agriculture and the Environment Institute for Advance Studies (IAS)
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