“Services and products in support of this research project were generated by the Tisch Cancer Institute Biostatistics and Clinical Informatics Shared Resource Facility, supported, in part, with funding from NIH-NCI Cancer Center Support Grant P30 CA0196521.\u201d<\/span><\/i>\u00a0<\/span><\/p>\n In addition, publications that acknowledge the CCSG\u202fmust also comply with the\u202f<\/span><\/b>NIH Public Access Policy<\/span><\/b><\/a> which states that a PubMed Central ID (PMCID) is\u202f<\/span><\/b>required<\/span><\/b>\u202fwhen you publish research that was supported by any NIH funds.<\/span><\/b><\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Authorship” _builder_version=”4.9.0″ _module_preset=”default” open=”off”]<\/p>\n Criteria for authorship for statisticians in medical papers (mssm.edu)<\/span><\/a>\u200b<\/p>\n The mechanism used to provide support does not alter the collaborative atmosphere that the TCI-BCI-SRF<\/span><\/span> has <\/span>fostered over the years. The contribution of each person needs to be evaluated as a manuscript is\u00a0<\/span>prepared. Consideration for authorship should be based on the accepted criteria for most medical journals.\u00a0<\/span>These criteria generally cite both study design and statistical analysis as intellectual input sufficient for\u00a0<\/span>authorship. It is impossible to define every situation in advance; however, it should be clear that\u00a0<\/span>reimbursement for time does not preclude or replace authorship. Please refer to some helpful guidelines\u00a0<\/span>below:\u00a0<\/span><\/p>\n https:\/\/cinj.org\/research\/biostatistics-authorship-policy<\/span><\/a>\u00a0<\/span><\/p>\n Collaborating statisticians qualify for authorship on manuscripts and abstracts if the criteria listed below are met. These criteria are derived from the\u202f<\/span>International Council of Medical Journal Editors Requirements<\/span><\/a>\u202fand from\u202f<\/span>Criteria for Authorship For Statisticians in Medical Papers, by Parker and Bergman, Stat. Med. 17, 2289\u20132299 (1998)<\/span><\/a>. Based on these references, examples of these criteria include, but are not limited to, the following:<\/span>\u00a0<\/span><\/p>\n Our policy is that MS and PhD statisticians should NOT be listed under acknowledgements if any of the above criteria have been met, but should instead be appropriately recognized as authors.<\/span>\u00a0<\/span><\/p>\n Authorship Order<\/span><\/b>\u00a0<\/span><\/p>\n It is recommended to discuss the authorship order at the initiation of the collaboration. The authorship order of the statisticians depends, as accurately as possible, upon their specific contributions. It is customary to list the faculty statistician as the second author if they have co-led the overall clinical study design, analysis, conduct, and manuscript preparation. If the clinical trial is led by another institution and the BSR faculty is not the lead statistician in the originating institution, then the BSR faculty should be listed as a middle author as long as they have contributed materially to the clinical study design, analysis, conduct, and manuscript preparation.<\/span>\u00a0<\/span><\/p>\n Payment and Authorship<\/span><\/b>\u00a0<\/span><\/p>\n Payment will not be accepted in lieu of authorship. Authorship is determined by intellectual and scientific contributions, as described earlier. Payment allows the collaborating statistician(s) to engage a project in accordance with NIH guidelines for effort reporting.<\/span>\u00a0<\/span><\/p>\n <\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Data Management” _builder_version=”4.9.0″ _module_preset=”default” open=”off”]<\/p>\n The TCI-BCI-SRF is not responsible for data management.<\/p>\n Here are some guidelines for data management:<\/p>\n Clinical data management is the process of collection, cleaning, and management of data in\u00a0<\/span><\/span>compliance with regulatory standards. It is an important part of any research study. Every\u00a0<\/span><\/span>interventional (I-IIT) should have a clinical data management plan and support of a research study\u00a0<\/span><\/span>assistant. Statisticians are available to assist in the development of the data management plan by\u00a0<\/span><\/span>offering guidance\u00a0<\/span>on:<\/span>\u00a0selecting the right electronic data capture system, the best data collection\u00a0<\/span><\/span>methods, data entry practices that ensure consistency with paper CRFs, data validation methods and\u00a0<\/span><\/span>proper transfer of data for statistical analysis. However, biostatisticians are not taking responsibility for\u00a0<\/span><\/span>data management.<\/span><\/span><\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Project Turnaround Timeline” _builder_version=”4.9.0″ _module_preset=”default” open=”off”]<\/p>\n All requests received through our <\/span><\/span>service\u00a0request form<\/span><\/span><\/a> will be assigned to a TCI-BCI-SRF statistician <\/span><\/span>within two business days. Once assigned, a statistician will respond to your inquiry within three business\u00a0<\/span><\/span>days to arrange for the first meeting. Timeline for the work to be done will be discussed in this meeting.\u00a0<\/span><\/span>For interventional\u00a0<\/span>investigator initiated<\/span>\u00a0protocols, movement to PRMC requires approval from the\u00a0<\/span><\/span>\u2018Biostatistics Design Workshop\u2019 (BDW), a committee of all statisticians in the TCI-BCI-SRF that meets weekly <\/span><\/span>on Thursdays from 2-3 pm. For grant applications, time for development of the statistical sections for a\u00a0<\/span><\/span>grant also ranges between 2-4 weeks depending on the readiness of the proposal in terms of having all\u00a0<\/span><\/span>information needed for writing the statistical sections.<\/span><\/span><\/p>\n <\/p>\n\n
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