Institute for Health Care Delivery Science

Services and Financial Model

The following are the areas of specialization for the TCI Biostatistics Shared Resource Facility.

Services provided

  • Grant Development and Review 
  • Investigator Initiated Trials (IIT) Protocol Development and Review

Related Information and Guidelines

  • Protocol Template to use for all Investigator Initiated Trials
  • Guidelines for Writing the research protocol by the World Health Organization (WHO)
  • Guidelines for Developing a protocol by Centers for Disease Control (CDC)
  • Guidelines for Completing a research protocol for observational studies
  • Guidelines for Designing a Research Study
  • Manuscript Development related to Investigator Initiated Trials (IIT)

Financial Model
We offer statistical collaboration for grant and IIT development free of charge to investigators supported by the NCI Center grant. Analysis directly related to IITs is something we also provide free of charge to such investigators. 

We provide a number of services

  • Data analysis for all existing projects
  • Study and experimental design for all projects
  • Assistance with all manuscripts
  • Priority work on grant proposals from this group
  • Assistance with journal clubs and paper review (from methodology perspective)
  • Assistance with research conferences (e.g., data analysis and pre-conference critiques of fellows' presentations)
  • Assistance with identification of research gaps to be able to initiate research
  • Teaching short courses in experimental design and analysis methodology catering to the particular disease system
  • K award mentoring

We recommend a collaboration plan in which the TCI Biostatistics Shared Facility and the collaborating basic science laboratories, clinical or population science units use your departmental/divisional operational funds or clinical revenues to support time for a specific team of biostatisticians to be involved in developing research programs in these facilities. View details on TCI long-term collaboration guidelines

Related Information and Guidelines

Please include one of the following acknowledgements in any and all publications using the services of the Biostatistics Shared Resource Facility:

"The authors wish to acknowledge the support of the Biostatistics Shared Resource Facility and NCI Cancer Center Support Grant P30 CA196521-01, Icahn School of Medicine at Mount Sinai, for ______________ (list services, e.g. study design and monitoring, analysis and interpretation of data, preparation of the manuscript or presentation).”

"The authors wish to acknowledge the support of ___________ (list names) of the Biostatistics Shared Resource Facility, Icahn School of Medicine at Mount Sinai, and NCI Cancer Center Support Grant P30 CA196521-01.”

To request any of the above services please submit a request form.

Expected Turnaround Time

  • Your request will be assigned to a BSRF statistician within two business days.
  • Once assigned, a statistician will respond to your inquiry within three business days for the first meeting. Timeline for the work to be done will be discussed in this meeting.
  • It takes two to four weeks for a protocol that has been submitted to a Disease-focus group (DFG), where the statistician generally gets the first draft of the study, to reach its submission to Protocol Review Monitoring Committee (PRMC). Movement to PRMC requires approval from the ‘Biostatistics Design Workshop’, a committee of all statisticians in the BSRF that meets weekly on Thursdays from 2-3pm.
  • Time for development of the statistical section for a grant also ranges between two and four weeks depending on the readiness of the proposal in terms of having all info needed for writing the statistical section.

The primary information we need to begin the process of developing the data management, sample size justification, and analysis plan for the proposed grant is a draft of the grant itself. The Specific Aims, Research Design and Methods sections are critical, but having the Background, Significance and Preliminary Studies sections are also important because they can provide valuable information for developing both the sample size justification and overall analysis plan. Biostatistics Shared Resource Facility (BSRF) statisticians provide support with grant writing to investigators, but it is highly recommended that the biostatistician be included in the proposal with percent FTE support.

Related Information and Guidelines

Prior to grant submission, the following information needs to be provided to the biostatistician involved at least 4 weeks before the deadline.

  • Funding agency
  • Submission date
  • Title of proposal
  • Proposed start and end date
  • Principal Investigator(s)
  • Our faculty’s role
  • % FTE over the proposed years
  • Annual direct costs
  • An updated version of the full application
  • Your department’s (financial) administrator’s name

Note to Biostatisticians: Please connect this administrator with Ms. Denise Williams at denise.williams1@mssm.edu.

Guidelines for Grant Support for Biostatisticians
Guidelines for Writing Grant Proposals for Clinical Research

Regulatory Services

For information on regulatory services including:

  • Support to obtain IACUC and IRB approvals
  • External regulatory support with IND/IDE submissions to the FDA
  • NIH grant applications
  • Guidance on protocol management and monitoring services

Visit the Office of Research Services (ORS).

Clinical data management is the process of collection, cleaning, and management of data in compliance with regulatory standards. It is an important part of any research study. Every investigator initiated trial (IIT) should have a clinical data management plan and support of a research study assistant. Statisticians are available to assist in the development of the data management plan by offering guidance on: selecting the right electronic data capture system, the best data collection methods, data entry practices that ensure consistency with paper CRFs, data validation methods and proper transfer of data for statistical analysis. However, biostatisticians are not taking responsibility for data management.

Related Information and Guidelines

Electronic Data Capture Systems (EDC)

  • RedCAP – a no-fee self-service web-based application that allows investigators to design your own database.

Case Report Form (CRF) Design

  • Here you will find CRF templates consistent with FDA standards. These forms serve only as templates and should be edited to meet study data collection needs as described in the protocol.

Data Entry

  • Single
  • Double – Double data entry ensures better consistency with paper CRFs.

Data Validation

  • Embed Range and Logic Checks in the EDC system to ensure data validity.
  • Please create queries and run routinely to ensure ongoing quality control.

Discrepancy Management

  • Discrepancies flagged during the data validation and/or double data entry processes need to be reviewed and resolved with documentary proof.

Medical Coding

  • Coding for Adverse Events should be done using the Medical Dictionary for Regulatory Activities (MedDRA). To request access to MedDRA email refdesk@mssm.edu.
  • Coding for Medications should be done using the WHO Drug Dictionary Enhanced (WHO-DDE)
  • Coding for Adverse Reactions should be done using WHO-ART

For clarification of any of the above data management activities please consult the NIH guidelines

Q: What information do I need to bring?

A: You are encouraged to contact the Biostatistics Core early in the development stage of your project, so that you can get advice on study design, data collection, and protocol management. Bring any information you feel will help you explain your project and its supporting science. If you have already collected data, you can bring it with you in electronic form, such as an Excel spreadsheet.

Q: How far in advance should I contact the Biostatistics Core?

A: Please use the following guidelines. You should contact the biostatistics core:

  • At least 1 month before a meeting abstract is due
  • At least 1 month before a RO1 grant is due
  • At least 6 months before a P01 grant is due
  • At least 6 months before a SPORE grant is due

Q: How long does it take?

A: Your request will be assigned to a BSRF statistician within two business days. Once assigned, a statistician will respond to your inquiry within three business days for the first meeting. Timeline for the work to be done will be discussed in this meeting. The time that it takes a protocol, once submitted to a Disease-focus group (DFG), where the statistician generally gets the first draft of the study, to reach its submission to Protocol Review Monitoring Committee (PRMC) varies from 2-4 weeks. Movement to PRMC requires approval from the ‘Biostatistics Design Workshop’, a committee of all statisticians in the BSRF that meets weekly on Thursdays from 2-3 pm. Time for development of the statistical section for a grant also ranges between 2-4 weeks depending on the readiness of the proposal in terms of having all info needed for writing the statistical section.

Q: How do I get my results?

A: Your statistician will provide you with the information you have requested. This may be as brief as an informal memorandum (for small projects) or as extensive as a technical report that can form the basis of a manuscript. In the preparation of a protocol document or manuscript, you will exchange information iteratively with your statistician.