Comprehensive Cancer Center, Pharmaceutical Research Services Records, 1985-2004

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Collection Number: AR.0081
Comprehensive Cancer Center Pharmaceutical Research Services Records, 1985 - 2004

This is a finding aid. It is a description of archival material held in the Duke Medical Center Archives in Durham, N.C. Unless otherwise noted, the materials described below are physically available in our reading room, and not digitally available through the World Wide Web. See the FAQ section for more information.


Collection Overview

Size: 23.0 linear feet 14 record storage boxes
Abstract: Pharmaceutical Research Services, part of Duke Comprehensive Cancer Center, consists of an Investigational Chemotherapy Service and a Cancer Clinical Pharmacology Laboratory and provides a broad range of services to support the conduct of clinical hematology/oncology research. Types of materials include laboratory notebooks, data, correspondence, clnical trials materials, and research materials from both academic and clinical research. Materials were created by academic and clinical research staff members of the following departments: Dept. of Medicine, Dept. of Pathology, and Dept. of Pharmacology and Cancer Biology.
Creator: Duke University. Comprehensive Cancer Center. Pharmaceutical Research Services.
Language: English
Repository Duke University Medical Center Archives
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Information for Users

Access Restrictions
This collection contains personal health information. Contact the Archivist for information about access. Contains University Administrative records. These include records of the officers of the University, as defined in the Bylaws, the deans of schools and colleges, and departments, institutes, and other offices as designated by the President. For a period of twenty-five years from the origin of the material, permission in writing from the director of the office of record and the University Archivist is required for use. After twenty-five years, records that have been processed may be consulted with the permission of the University Archivist. (Issued by the Office of the Chancellor, December 1, 1975).
This collection may contain material with sensitive or confidential information that is protected under federal or state right to privacy laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA). Researchers are advised that the disclosure of certain information pertaining to identifiable individuals represented in this collection without the consent of those individuals or IRB approval may have legal ramifications (e.g., a cause of action under common law for invasion of privacy may arise if facts concerning an individual's private life are published that would be deemed highly offensive to a reasonable person) for which Duke University assumes no responsibility.
Copyright Notice
Copyright for Official University records is held by Duke University; all other copyright is retained by the authors of items in these papers, or their descendants, as stipulated by United States copyright law.
Preferred Citation
[Identification of item],Pharmaceutical Research Services records, Duke University Medical Center Archives.
Acquisitions Information
Transfer; A2005-027; 2005.
Sensitive Materials Statement
Collections may contain Medical Center Administrative records. These include records of the officers of the University, as defined in the Bylaws, the deans of schools and colleges, and departments, institutes, and other offices as designated by the President. For a period of twenty-five years from the origin of the material, permission in writing from the director of the office of record and the Medical Center Archivist is required for use. After twenty-five years, records that have been processed may be consulted with the permission of the Medical Center Archivist.
Collection may contain Records of the Board of Trustees of the Duke University Medical Center. These include minutes and supporting documentation of the Board, its Executive Committee, and standing and ad hoc committees, and reports, studies, and the like presented solely to the Board. Records which have been existence for at least fifty years are available for scholarly research with the permission of the Medical Center Archivist. Access to records which have been in existence for less than fifty years shall be granted only by special permission, in writing, of the Medical Center Board of Trustees.
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Subject Headings

The following terms from Library of Congress Subject Headings and Medical Subject Headings suggest topics, persons, geography, etc. interspersed through the entire collection; the terms do not usually represent discrete and easily identifiable portions of the collectionsuch as folders or items.

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Related Collections


Historical Info

The Pharmaceutical Research Services, consisting of an Investigational Chemotherapy Service and a Cancer Clinical Pharmacology Laboratory, provides a broad range of services to support the conduct of clinical hematology/oncology research. The Investigational Chemotherapy Service, primarily located in the Morris Clinical Cancer Building, is available to all Cancer Center investigators for the purpose of maintaining drug accountability records and investigational drug inventories according to FDA and CTEP guidelines. In addition, this resource provides design consultation, professional staff education, implementation and report completion services for all clinical research studies. Adverse drug reaction reports from clinical trials are submitted to the service and evaluated to ensure compliance with regulatory agencies.

The Clinical Pharmacology Lab is located in the Morris Clinical Cancer Building of Duke South Hospital. It functions as both a clinical research and clinical reference lab for cytokines and cytotoxic drugs. The lab routinely collaborates with a variety of Duke Cancer Center members in addition to functioning as a core facility for several investigators outside of Duke. The lab also provides both consultative and analytic services regarding clinical pharmacokinetic studies of anticancer compounds and recombinant proteins.

As of 2005, the Pharmaceutical Research Services is under the co-directorship of Dr. David Adams and Dr. Ashley Morris.

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Scope and Content

Organized into the following series: Records, 1985-2004.

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Contents list

Series Quick Links

Records, 1985-2004


Box 1
GCSF Biological Assays
AA Pt results, BMTP
AA Pt results, Trump - Total Pt, 1992
AA Pt results, Trump - Urine Pt, Urine/UF Pt runs, carboplat adducts, 1991-1993
Requisitions, 1992
Protocol for treatment of metastatic melanoma using BCNU and CSFs
GCSF slides

Box 2
AA Pt results, Trump - UF Pt, 1991-1992
AA Pt results, Trump - total Pt, 1992, BMTP, 1992-1993
Requisitions, 1991
LMS study, phagocytes and H2O2 assays, 1990
Summer project, Caroline Gupton, 1992
CGH, 1995

Box 3
AA Pt results, BMTP, 1993
Requisitisons, 1993
Requisitisons, 1995
Endogenous factor assays
GMCSF, 1992
Freezer (data), circa 1990
GCSF EIA assays, 1990
Erythhroprotein assay developemnt

Box 4
GMCSF studies
IL - 1, 1990
Diagnostic Immunology and Syphilis Serology inspection manual, 1992
IL - 3 patients, 1992
Requisitions, 1994
TNF alpha, 1990
GMCSF ELISA, 1990

Box 5
Statistics
EIA assasys, 1991
AA Pt results, DNA adducts, Carboplat, 1993
Alopeda, 1994
EIA procedures, 1992
AA Pt results, BMTP, 1993-1994
IL - 1, 1991

Box 6
Procedures, 1990
Molecular Devices Corporation
Participant dose data, 1985-1989
CTX data for 8782 study, 1991

Box 7
Pediatrics CNS: Carboplatin MTSE, 1995-1996
Pediatrics CNS 14
ABT-538 Ritonavir investigator brochure
Correspondence and publications, 1997-1999

Box 8
ICAM, M - Z
Posters, CSFs and Endogenous Cytokines I
ICAM, A - L
CNS 14
Loose files

Box 9
Investigators meeting, protocols RC749J101-00 and RC749J102-00, 1999
Banyu Phase I Compound J107088, multiple dose study, 1999
Banyu Phase I Compound J107088, multiple dose study, clinical sample tracking log book, 1999
Banyu Phase I Compound J107088, single dose study, clinical sample tracking log book, no. 1-12, 1999
Banyu Phase I Compound J107088, single dose study, clinical sample tracking log book, no. 13-29, 1999

Box 10
Banyu J107088 studies, HPLC (plasma) use and maintenance log
Banyu J107088 valudation study, book 1
Banyu J107088 valudation study, book 1, urine
Banyu loose files
Banyu J107088 plasma samples, book 1
Banyu J107088 urine samples, book 1

Box 11
Banyu J107088 plasma Valid relation study chromotograms
Banyu J107088 urine files
Banyu J107088 studies, urine files
LPAM standard curve, 2002
Melphan perfusion study

Box 12
LPAM standard curve, 2002
Melphan perfusion study
Lung study, 9531
MGSF sample collection, 951002
Thalidomide study
Doxil hyperthermia study
ABX-EG-9901
OCT-43IL - 1b, endogenous cytokines
Mouthwash, ASH, 1993
Cartee thesis, 1993

Box 13
GM-CSF mouthwash study
Modlin, 1993
GM-CSF mouthwash study
Cyclophosphamide GC/MS, results for Johns Hopkins samples
Pediatric CNS: Carboplatin MTSE

Box 14
EPO, 1993-1995
Pediatric CNS 14 records, book 2
Pediatric CNS: Carboplatin MTSE
Tetraplatin I

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