Clinical Pharmacology Analytical CorePolicies & Procedures
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 Analytical 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, effective, Sept. 1, 2012, for services of the Clinical Pharmacology Analytical Core are as follows:
|IU School of Medicine||Commercial/Outside Vendor|
|Sample Charges (plasma)||$47/sample||$60/sample|
|Sample Charges (tissue)||$92/sample||$117/sample|
Acknowledgment, authorship and collaboration:
All research work performed by CPAC should be acknowledged in all ensuing publications. Fees paid for services provided by 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 CPAC. Given that many validation procedures and CPAC offered services require advanced intellectual involvement by the CPAC scientists, 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.
Conflict Resolution: If a potential conflict develops, the director of CPAC and customer will meet and attempt to resolve the dispute. If they fail to resolve the dispute, the disagreement shall be referred to the chair of the Clinical Pharmacology Analytical Core Advisory Committee (Mark R. Kelley, PhD) as an arbitration committee.
Confidentiality policy: 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. PI will have ultimate control over any public disclosure of the scientific results generated in the core.
Cost recovery/payment policy: If recovery of payment becomes an issue, the IUSCC business managers (Mike Darling and Elizabeth Parsons) will contact the customer and/or their department to collect charges owed to CPAC. If there is a dispute in charges, CPAC will follow the conflict resolution policy above.
Prioritization of work policy: Core studies or services will be prioritized based on IUSCC membership followed by IUSM and non-members. Investigators who would like to utilize the core are required to submit the consultation form. Priority will be given to users with peer-reviewed grant funding. When the requests are received by CPAC and if the work will be delayed for any reason, the director of the core will communicate to the customer.
Certification Status: Currently, CPAC is a non-CLIA, non-GLP certified lab and all data are used for research purposes only by the PI. Validated methods produced by CPAC could be transferred to the IU Health Pathology Laboratory if the PI wants to apply methods to modify patient therapy.