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Standard Operating Procedures

Chao Family Comprehensive Cancer Center at UC Irvine School of Medicine has established the Biostatistics Shared Resource (BSR) to assist investigators associated with the Cancer Center to conduct and communicate research of the highest possible quality. The primary activities of the Biostatistics Shared Resource include:

  • Statistical and design issues for new studies
  • Statistical analysis of data and consultation
  • Development of clinical research protocols

The BSR has been involved in the data analysis of a wide variety of projects, including genetic epidemiology studies, cancer etiology research, clinical studies to evaluate biological markers, assessment of diagnostic methods and treatment modalities, cancer prevention clinical trials and in vitro studies. Priority will be given to cancer center members and cancer-related studies. This document describes the standard operating procedures for statistical consulting and for recharge policies. You can conveniently download a copy of these operating procedures here: Standard Operating Procedures. For information regarding administration of recharge fees, contact Jacqueline Orozco, Assistant Director for finance and operations.

Cancer-Related Studies
Grant preparation: A primary function of the BSR is to provide assistance to all funded Cancer Center members and their co-investigators with grant preparation for cancer-related studies. The effort for assistance with grant preparation for cancer-related studies will be free-of-charge to funded Cancer Center members and their co-investigators. The following policies and guidelines for new grant preparation will apply:

  1. Submitted grant budgets should include the following for future statistical services: (1) percent effort for one or more named statisticians from the BSR, or (2) a budget allocation for statistical service to be paid on the basis of recharge.
  2. The BSR biostatistician will be given adequate time to work on the submission prior to its due date and will be involved in all aspects of study development, including, but not limited to, study design, determining measures and outcomes, sample size calculations and data analysis.
  3. The BSR biostatistician will review the final grant application prior to submission to ensure consistency in the design, analysis and sample size consideration sections as well as ensuring that reasonable funds for statistical support are allocated in the event of funding.

This effort is partially supported through the Cancer Center’s shared resource grant and provision of assistance will depend upon the current workload of the Resource as determined by the Director and faculty of the BSR.

Data analysis and abstract, manuscript, and presentation preparation: The BSR also will assist cancer center members and their affiliates and non-cancer center members with data analyses and preparation of abstracts, papers, and presentations. A recharge will be made for these services and standard hourly rates will apply. The applicable rates may be found here: Consultation Rates. The cancer center will pay for the first hour of service for all funded members and their co-authors for any cancer-related activity. The following policies and guidelines will apply: 

  1. The biostatistician performing the analysis will be a co-author on the publication to acknowledge the intellectual contribution to the work.
  2. Statistician co-authors will use their primary appointment affiliation on manuscripts and abstracts.
  3. Co-authorship will not be considered as compensation.
  4. The biostatistician will be given adequate time to review any abstract or publication prior to submission and resubmission in order to ensure study and statistical integrity.

Non-Cancer Related Studies
The BSR can also assist with grant development, data analysis, and preparation of abstracts, papers, and presentations for non-cancer related studies. Provision of statistical help will depend upon the current workload of the Resource as determined by the Director and faculty of the BSR. A recharge will be made for statistical services. The potential of grant funding will not be considered as compensation. Grant budgets for non-cancer related studies should include the following for future statistical services (1) percent effort for one or more named statisticians from the BSR, or (2) a budget allocation for statistical service to be paid on the basis of recharge. Non-Cancer Center members will be encouraged to meet with Jacqueline Tidball, Research Administration, regarding application for Cancer Center membership. Regardless of membership any publications resulting from assistance by the BSR should acknowledge that biostatistical collaboration was provided by the BSR. One example of an appropriate acknowledgment is:“Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number P30CA062203. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Biostatistics collaboration was provided by the Biostatistics Shared Resource within the Chao Family Comprehensive Cancer Center at the University of California, Irvine.”

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