The Pharmacotherapy Research Center (PRC) is a collaborative hub for the School of Pharmacy and Pharmaceutical Sciences

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Involvement from Concept to Presentation

The knowledge base and skills found at the PRC CAL allow registered PRC investigators to involve the PRC CAL's personnel from the hypothesis of a project to the final presentation of a project's findings. Registered investigators submit proposals through the PRC CAL registered PI site domain. PRC CAL managers receive this proposal and a meeting is scheduled to begin assessment of the project's feasibility.

Managers can assist in researching the analytical means required: developing analytical concepts, providing documentation of validated methods, budgeting analytical requirements, and drafting proposal methods sections. In addition, proposed clinical study conduct details can be formulated for specimen data collection, specimen collection, specimen processing and storage, specimen labeling, and specimen shipments.

Once a project is funded, it will move through its life-cycle in several phases: pre-initiation, initiation, conduct, reporting, closure and archival. Quality assurance is ongoing throughout all processes.

During pre-initiation, the PRC CAL may develop and validate the analytical method(s), prepare study forms and instructions, and create a study specific data base. The method of analysis identified is tailored for the standardization and sensitivity required by the study. Correspondence between the investigator and clinical research unit and/or the PRC CAL are required during this phase to accurately and specifically prepare the study sample forms and create the necessary corresponding fields in the study database. The forms and instructions are prepared to assure that the samples and sample information received by the PRC CAL for analysis will be of the best integrity, HIPAA compliant, suitable for analysis and uniquely identifiable. The database is designed so that the investigator receives the final data files with the specific identifiers s/he requires for data analysis.

Once a project is initiated, the PRC Cal personnel will work with the investigator and/or clinical site(s) to receive and analyze the samples, communicate ongoing inventories and results and provide reports as needed. Billing for sample analysis will occur as agreed upon with the project investigator.

At the completion of the analytical project, an analytical report is issued. The report contains the raw data results, an overview of the project conduct at the PRC CAL, and standardization and quality control summaries. Manuscript sections for methods can also be provided as needed. In the event that a new analytical method was developed for the project, the PRC CAL will prepare a method manuscript for submission to an appropriate journal; co-authorship of PRC CAL is required.

During project closure, samples are moved to long-term storage or shipped back to the investigator. The shipment records, analytical records and other records are moved to archival for storage. The database and other electronic records are archived to electronic storage media and stored.

Samples and records are kept in archival for at least five years and are only discarded with investigator approval.

Investigator Options

Some investigators may not require all the assistance that the PRC CAL provides. Investigators may also require elements that are not standard to the PRC CAL operations. In either case, the PRC CAL will strive to provide the elements of service that the investigator requires. When additional elements are required the PRC CAL managers will investigate the feasibility of meeting the investigator's needs.

Previous examples of meeting investigator specific needs are:

NYDOH certification for a method
Creation of interactive laboratory specific website
Active involvement on study specific conference calls or attendance to off-site meetings
Development of multi-analyte assays
Preparation and shipping of sample collection kits

Project Driven

PRC CAL activities are driven by the projects that they are conducting. As such, the availability of a method and its supporting laboratory structures (study forms and instructions, analytical equipment, databases, etc) are subject to change. While making a validated method available is not nearly as involved as developing and validating a new method, the PRC CAL requires that the time and resources be planned prior to sample analyses. In addition, the prior dedication of the laboratory resources to earlier contracted work may sometimes necessitate that a waiting period occurs.

Electronic Management with back-up

PRC CAL data management strives to ensure that all transcriptions of data are electronic whenever feasible. The PRC CAL has its own secure server system(s) that are copied nightly for data rescue purposes. All chromatography equipment is managed by electronic acquisition stations driven by manufacturer specific software. The same software packages allow for the collection of the method analysis data, calibration and calculation of results. Results are electronically exported to excel data files and imported into the access databases. ALL MANUALLY transcribed data are checked for accuracy by 100% audit of the entry. A peer review process is utilized to verify the data entry accuracy.