Shared Facilities

Clinical Pharmacology Analytical Core

Policies & Procedures
Clinical Pharmacology Staff
Andi Masters, laboratory manager; David Jones, core director; Diana Ljuldjuraj, laboratory technician

If you are interested in using the Clinical Pharmacology Analytical Core, the first step is to fill out and submit a consultation form.

After the initial consultation, investigators may then provide the Clinical Pharmacology Analytical Core with drug (and/or metabolite), internal standard, biological samples and a high performance liquid chromatography column.

Initially, the core performs multiple tests to identify the optimum detector settings, chromatography system and purification procedures for quantification of compound. Biological samples will be assayed when a standard operating procedure has been resolved. Then, the results (in units of concentration) will be communicated to the investigator.

Chargeback Rates

Chargeback rates*, effective, July 1, 2013, for services of the Clinical Pharmacology Analytical Core are as follows:

Internal IU faculty rates External rates
Method development $209/hour $265/hour
Sample Standardization $74/sample $94/sample
Protein Binding $209/hour $265/hour
Sample Charges (plasma) $74/sample $94/sample
Sample Charges (tissue) $148/sample $188/sample
Data Development $209/hour $265/hour

*Prices are subject to change. Please work with the CPAC director for current process and pricing before including costs for internal and external budgets.

Misc.

Confidentiality: Data generated by the core is kept on a secure server with access to core personnel only. Data or information (verbal and/or electronic) are not shared with any outside parties. We treat all information received from our customers as confidential and privileged. Unless authorized by the customer, we will not disclose, copy, distribute or share data. Samples delivered to CPAC are required to be de-identified; however, if samples are not de-identified, they will be returned to the PI immediately. The PI will have ultimate control over any public disclosure of the scientific results generated in the shared resource.

Conflict resolution: If a resolution cannot be reached at the core director level, the issue will be taken to the core advisory committee for discussion and resolution.

Cost recovery/payment policy: If recovery of payment becomes an issue, the IUSCC business managers will contact the customer and/or their department to collect charges owed. If there is a dispute in charges, the conflict resolution policy above will be followed.

Prioritization of work: IU Simon Cancer Center and IU School of Medicine investigators have full access to services provided by the CPAC. Investigators planning to use the CPAC must fill out the consultation form. Projects enter the queue upon receipt of the consultation form. In the event that there is a back-log in activities, CPAC studies or services will be prioritized based on IU Simon Cancer Center and/or IU School of Medicine membership followed by non-members. Priority will be given to users with internal pilot or external peer reviewed grant funding.

Acknowledgement, authorship and collaboration: All research work performed by the CPAC should be acknowledged in all ensuing publications. Fees paid for services provided by the CPAC should not negate the potential of co-authorship by CPAC scientists. These acknowledgements and achievements are important for the existence and continued funding of the CPAC. Given that many validation procedures and CPAC offered services require advanced intellectual involvement by the CPAC scientists (see “Examples”), it is expected that this acknowledgement will be in the form of co-authorship according to the guidelines for authorship recommended by the International Committee of Medical Journal Editors.