Subject Matter Expert (SME) Guidance

Collaboration or consultations with subject matter experts can optimize clinical protocol development. Below is a list of SMEs to consider consulting with when designing a protocol.

BioMedical Engineering and Imaging Institute (BMEII)

What

The BioMedical Engineering and Imaging Institute (BMEII) provides support for all in vivo imaging research including neuroimaging, cardiovascular imaging, cancer imaging, nanomedicine (molecular imaging and drug delivery), and image processing in the preclinical and clinical settings.

Investigators are encouraged to consult with the BMEII technical directors for assistance with:

  • Study design
  • Imaging protocol design
  • Use of imaging technologies
  • Feasibility of the research
  • Equipment availability
  • Scientific merit

How

Consults can be scheduled by reaching out to the applicable technical director experts.

Cardiac and Cardiovascular Projects
Zahi Fayad, PhD
zahi.fayad@mssm.edu

Small Animal Imaging
Cheuk Tank, PhD
cheuk.tang@mssm.edu

When a study involves animal subjects, a discussion with the Center for Comparative Medicine and Surgery (CCMS) should also be initiated.

Neuroimaging
Priti Balchandani, PhD
priti.balchandani@mssm.edu

Cancer
Bachir Taouli, MD
bachir.taouli@mountsinai.org

Body Projects
Bachir Taouli, MD
bachir.taouli@mountsinai.org

General Inquiries
Christopher Cannistraci
christopher.cannistraci@mssm.edu

Biorepository and Pathology CoRE

What

The Biorepository and Pathology CoRE provide services to support clinical, translational and basic research including:

  • Histology, special stains, and tissue microarray generation
  • Immunohistochemical and immunoflourescent staining
  • Laser capture microdissection
  • Whole slide scanning and image analysis
  • Molecular DNA/RNA extraction
  • Biorepository – tissue/body fluid procurement, storage and tracking
  • Protocol design

How

Investigators are encouraged to consult with the Biorepository and Pathology CoRE to discuss the intended study, protocol design and research fees.

For more information contact:

Rachel Brody MD, PhD
Director, Institutional Biorepository and Pathology CoRE
rachel.brody@mountsinai.org

Center for Biostatistics

What

The Center for Biostatistics provides long-term and short-term consultative support in:

  • Study design
  • Sample size calculations
  • Data analysis
  • Interpretation and dissemination of study results
  • Data management
  • Education and training

Special Areas of Expertise:

  • Design of early phase and adaptive trials
  • Machine learning and analysis of high throughput data
  • Pragmatic and registry-based studies
  • Analysis of large/administrative datasets
  • Environmental statistics

How

Biostatistics CoREs

The Center for Biostatistics has established Biostatistics CoREs to support the statistical needs of the following departments and institutes:

  • Anesthesiology
  • Medicine
  • OB/GYN
  • Psychiatry
  • Pediatrics
  • Surgery
  • Emergency Medicine
  • Palliative Medicine
  • Environmental Medicine and Public Health
  • The Cardiovascular Institute
  • Institute of Adolescent Health
  • Institute of Transformative Clinical Trials
  • The Tisch Cancer Institute
  • Institute for Personalized Medicine
  • Biomedical Engineering and Imaging Institute
  • The Institute of Translational Epidemiology

To request biostatistics CoREs support contact:
Yvette Hutson
yvette.hutson@mountsinai.org
212-659-9569

Oncology Biostatistics Support
Consultations are mandatory for cancer related protocols. To request oncology biostatistcs support submit the Cancer Institute Request form.

BERD Consultation Services

BERD Consultation Services support the departments and institutes that are not covered by the Biostatistics Cores.

Request consultation services by submitting the online BERD Service Request Form.

Cost – $125 per hour

STAT-CHAT Walk-in Consultations

Free walk-in consultation service meant to resolve easy problems and answer quick questions about such topics as data analysis, study design, and database. All faculty, fellows, residents, staff, or medical students are welcome to use this service for quick statistics-related questions. Two statisticians are available for an hour on a first-come, first-served basis. Each consultation should be about 15 minutes.

Every Monday, 2:00 – 3:00 PM

STAT-CHAT Virtual Consultation Service

Cancer Biostatistics Walk-In Clinics

A biostatistician provided by The Tisch Cancer Institute-Biostatistics Shared Resource Facility will be available for quick statistical consultation on a first come, first served basis. The purpose of this clinic is to answer general statistical questions and to provide guidance for current and future cancer research projects.

1st and 3rd Wednesday of Every Month, 1:00 – 2:00 PM
Hess Building
1470 Madison Avenue
Room 6-122
Cancer Biostatistics Walk-In Clinic Event Calendar

Educational Programs

Visit the Center for Biostatistics website to learn more about their Educational Programs.

Questions

For more information contact:
Yvette Hutson
yvette.hutson@mountsinai.org
212-659-9569

Resources

Centers for Community and Academic Research Partnerships (CCARP)

What

The Centers for Community and Academic Research Partnerships (CCARP) provides support to Mount Sinai researchers and local community partners to develop and conduct community-involved research projects.

CCARP offers consultations that can:

  • Assist with grant applications and NIH training awards.
  • Connect you with experts in the fields of data management, health policy, community-engaged research, ethical issues, multicultural and community affairs, and research design, when appropriate.
  • Provide information and support on the best practices in a range of community-involved research methods, including community-based participatory research.
  • With the help of a partnership board of community and academic leaders, help generate novel research ideas and advise researchers and community members on how to further their aims.
  • Serve as a conduit for an academic to request to present a project to the Partnership Board to gain further insight.
  • Suggest activities to promote formal and informal interactions between community members and academic researchers that increase the value of your project to the community and your knowledge of your community; this includes meetings, conferences, and tours both of East Harlem (primarily for researchers) and Mount Sinai for a day of learning about research (primarily for community members).
  • Connect you with both academic and community experts in community-engaged research, health disparities, and/or community outreach and education.
  • Provide feedback regarding the development of research projects and/or protocols.

How

To request a consultation contact:

Crispin Goytia
crispin.goytia@mountsinai.org

Provide the following information in your inquiry:

  • Name
  • Title/degree (if applicable)
  • Mount Sinai or QHN Department/Division (if applicable)
  • Mailing address
  • E-mail address
  • Attach CV (if applicable)
  • Nature of request

Cost

Consultations are free for investigators interested in community-engaged research.

ClinicalTrials.gov Reporting Requirements & Protocol Development

ClinicalTrials.gov Requirement
Protocols, Statistical Analysis Plan and Consents must  be uploaded to the ClinicalTrials.gov website after enrollment is completed. All documents will be made public on the ClinicalTrials.gov website.

ClinicalTrials.gov Registration Considerations

  • Once registered/released on ClinicalTrials.gov, the study record CANNOT be deleted.
  • Responsible party will need to provide explanation why a study is suspended, withdrawn, or terminated.
  • Any data that is collected will need to be provided to ClinicalTrials.gov, regardless of study status, for the record to be deemed in compliance on ClinicalTrials.gov.
  • Reason must be provided for why data was not collected for any missing result information.

ClinicalTrials.gov Registration Process

  • Submit ClinicalTrials.gov Registration Assistance ticket to the Office of Research Services (ORS).
  • Information is reviewed and uploaded to the ClinicalTrials.gov website within 1-3 business days of receiving the registration form. ORS may make changes to be consistent with the language that ClinicalTrials.gov prefers.
  • Draft is sent to the research team to review and correct before study record is released on ClinicalTrials.gov.
  • The QA Team at ClinicalTrials.gov reviews within 2-5 business days after study record is released, at which time they will either provide an NCT number or they may make a request for clarifications.

ClinicalTrials.gov Results Reporting Considerations

Results are required for:

  • All studies funded in whole or in part by the NIH
  • Studies meeting the definition of applicable clinical trial
  • As required by the sponsor
  • Publication for most journals.

Data Requirements:

  • Data Results represented in numeric form at the completion of the study.
  • Data Results to be provided as raw data as well as the statistical analysis.
  • Data Results to be provided separated out by arms for the outcome measures, as well as adverse events.
  • For baseline characteristics, data is required to be separated out by arms as well as for the full enrollment.
  • Data results are required to be entered into ClinicalTrials.gov for all primary and secondary outcome measures listed in the protocol.
  • Data results and analysis are expected regardless if it is ultimately published in any journals.
  • Consider designating exploratory outcome measures where appropriate in the protocol.
  • Consider time points of outcome measures. If protocol states data will be collected and will be analyzed at every time point, ClinicalTrials.gov expects data results to be provided for all time points listed in protocol.
  • “Data not analyzed” is never an accepted reason for why data is not provided for any particular outcome measure.

Timeline for ClinicalTrials.gov Registration Consideration

Registration – once released to ClinicalTrials.gov website, QA team at ClinicalTrials.gov will review within 2-5 business days at which time they will either provide the NCT# or they may make a request for clarifications. After the NCT number is provided, it will take an additional 2 days for the study record to appear on the ClinicalTrials.gov website.

Results – once released to ClinicalTrials.gov, QA team at ClinicalTrials.gov will review within 30 days.

  1. If it passes their QA review, results will be published and made public within 2 business days.
  2. If they make a request for clarifications, results will be made public along with their comments and an indication to state the results are not final. The research team will have 21 days to respond to their comments and the QA team at ClinicalTrials.gov will have another 30 days to review.

(ClinicalTrials.gov collects metrics on all organizations/institutes on how many efforts it takes to pass their QA review in addition to timely response.)

Human Immune Monitoring Center (HIMC)

What

The Human Immune Monitoring Center (HIMC) in the Precision Immunology Institute leverages their immunological and technical expertise to offer consultation in developing study-specific biospecimen collection protocols and innovative immunologic assessment plans and approaches to evaluate immune responses in clinical studies. HIMC provide:

  • Study Design and Consultation
  • Biospecimen Processing and Sample Management
  • Soluble Factor Profiling
  • Phenotypic and Functional Immune Cell Characterization
  • Immunogenomics and single Cell Transriptomics
  • Multiplexed Tissue Imaging
  • Data Management and Analysis

How

For more information, refer to HIMC Study Design and Consultation.

Institute for Translational Epidemiology (ITE)

What

The Institute for Translational Epidemiology (ITE) is committed to expanding the role of epidemiology in clinical research. ITE provides expertise and resources to support Mount Sinai researchers, through collaborations, consultations, and training courses.

Resources

  • World Trade Center (WTC) Biorepository of human and animal tissue samples
  • General Thoracic Surgery STS Database
  • Training courses:
    • Introduction to Qualitative Research Methods (Mount Sinai)
    • Introduction to the Use of Healthcare Database for Population Health Research (Mount Sinai)
    • Healthcare Data Science Course (University of Brescia, Italy)
  • The Center for Cancer and Aging
  • Center for Disaster Health, Trauma and Resilience

Expertise

  • Large datasets
  • Epidemiological methods
  • Chronic disease epidemiology
  • Cancer Epidemiology
  • Environmental Epidemiology
  • Genetic Epidemiology
  • Infectious Disease Epidemiology
  • Mental Health
  • Disparities Research

How

For more information, please refer to the Institute for Translational Epidemiology (ITE).

Investigational Drug Service (IDS)

What

The Investigational Drug Service (IDS) is a research pharmacy charged with maintaining the control and accountability of investigational agents (FDA approved and non-approved) in compliance with Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs) and other regulations and laws as appropriate at Mount Sinai.

The IDS provides research support including:

  • Protocol design, development, and review
  • Create randomization schemes
  • Product procurement
  • Storage, preparation, and dispensing
  • Coordinating drug services for multi-center trials
  • Training and education

How

To schedule a consultation and/or training and education contact IDS.

Transfusion Medicine and Cellular Therapy

What

The Transfusion Medicine and Cellular Therapy Laboratories in the Department of Pathology, Molecular and Cell-Based Medicine provide therapeutic apheresis, blood banking and cellular therapy laboratory services to support clinical research involving blood products, collection of cellular components, processing and handling of cellular products.

How

Investigators are encouraged to contact the Transfusion Medicine and Cellular Therapy services and seek advice during grant-writing and protocol development process as it follows:

Blood Bank
Dr. Jeffrey Jhang, MD
Director, Blood Bank and Transfusion Services | Mount Sinai Health System
Professor and Vice Chair of Pathology, Molecular, and Cell-Based Medicine | Icahn School of Medicine at Mount Sinai
Phone: 212-659-8181 (x88181)
E-mail: jeffrey.jhang@mountsinai.org

Therapeutic Apheresis
Dr. Suzanne Arinsburg, DO
Medical Director, Apheresis| Mount Sinai Hospital
Assistant Professor of Pathology, Molecular, and Cell-Based Medicine | Icahn School of Medicine at Mount Sinai
Phone: 212-241-3690 (x43690)
E-mail: suzanne.arinsburg@mountsinai.org

Cellular Therapy
Dr. Camelia Iancu-Rubin, Ph.D.
Director, Cellular Therapy Laboratory
Associate Professor of Pathology, Molecular, and Cell-Based Medicine | Icahn School of Medicine at Mount Sinai
Phone: 212-241-8589 (x48589)
E-mail: camelia.iancu-rubin@mountsinai.org

Data Management

Data and Safety Monitoring

What

The IRB ensures that every research protocol has an adequate monitoring plan in place to assure the safety of research subjects [45 CFR 46.111(a)(6) and 21 CFR 56.111(a)(6)]. The type and degree of monitoring required is related to the degree of risk involved, nature, size, and complexity of the research study.

How

To learn more about the monitoring plan requirements, see Data Safety Monitoring Plans.

Data Collection and Management

eRAP

The eRAP Rapid Database Generator (eRAP RDG) is a 21 CFR Part 11 compliant web-based interactive tool for data entry and reporting. eRap can be used to develop custom databases for longitudinal single and multi-site studies. Services include:

  • Reporting tools
  • Randomization engine
  • Data upload
  • File upload

REDCap (Research Electronic Data Capture)

REDCap is a secure, self-service, web based electronic data capture system that can be used to build and manage surveys and databases.

Some features of REDCap include:

  • Fast and flexible
  • Customizable
  • Send files securely
  • Export data to Excel and statistical packages (SAS, SPSS, R, Stata)
  • REDCap API
  • Import data
  • HIPAA and 21 CFR Part 11 Compliant

Biospecimen Procurement, Collection and Management

BioMe™ BioBank Program

What

The BioMe™ BioBank Program is an electronic medical record-linked biobank that enables researchers to conduct genetic, epidemiologic, molecular, and genomic studies on large collections of research specimens linked with medical information.

BioMe offers the following:

  • DNA aliquots that may be used for interrogating genetic variation (genotyping) and/or chromosomal abnormalities
  • Plasma
  • Phenotypic data – BioMe Informatics and Genomic Analysis Center (BIGDASC)
  • Genotypic data
  • Whole exome sequence and genome-wide array data, through an agreement with the Regeneron Genetics Center
  • Re-contacting services (recruitment method for separate prospective research requiring cohort of interest)
  • DNA extraction services for non-clinical research samples

How

For more information or to request services, visit the BioMe BioBank.

The Institute for Personalized Medicine administration and faculty will review all research requests for scientific merit, clinical relevance, feasibility, and conformity with BioMe Biobank Program policies and guidelines.

Questions

Contact BioMe™ BioBank

Biorepository and Pathology coRE

What

The Biorepository and Pathology coRE supports:

  • Tissue and body fluid procurement
  • Storage and tracking from consented and de-identified collections
  • DNA, RNA and miRNA extraction
  • Histology, special stains and tissue microarray generation
  • Whole slide scanning and image analysis
  • Immunohistochemical and immunofluorescent staining
  • Laser capture microdissection
  • Protocol development

How

Collection Activities

Researchers interested in collection activities should schedule a consultation with the Biorepository and Pathology CoRE Director.

Requests should include a detailed outline of the following:

  • Specific aims of the research projects
  • Specific tissue/body fluid requirements
  • Scientific rationale
  • Anticipated downstream techniques/assays of biospecimens
  • Number of specimens requested
  • Type of specimen preparation (fresh, frozen, RNA later, formalin fixed)
    • Anticipated clinical information

Biospecimen Procurement

Please contact the Biorepository and Pathology CoRE Director for biospecimen distribution inquiries.

Questions

Rachel Brody MD, PhD
Director, Institutional Biorepository and Pathology CoRE
rachel.brody@mountsinai.org

Biorepository of WTC Solid Cancers

What

The Biorepository of World Trade Center (WTC) Solid Cancers is a resource that enables researchers to conduct studies on cancer etiology, biology, and outcome, as well as gene-environment interactions. The Biorepository of WTC Solid Cancer offers:

  • cancer specific animal and human tissue samples
  • comprehensive clinical and pathology information
  • the responder samples are de-identified

Learn More

LabVantage Biorepository Management System

What

ConduITS has implemented the LabVantage Biorepository Management System for the MSHS research community to reduce the barriers to entry for biospecimen collection. ConduITS provides the software licenses and maintains the servers, databases, and the application. ConduITS also provides consultation and basic training on project setup, master data entry, and label generation.

This biorepository management system can be used to support ad hoc sample collection as well as defined protocol-driven sample collection. Donor registration, consent, and common sample annotation can be captured in a single system to ease the future sample search and report. This system also uses role-based access control to protect donor’s privacy. This system tracks the sample processing, storage condition, and the chain of custody to provide a complete picture about a sample’s lineage.

How

To learn more contact:

Xin Zheng, PhD
xin.zheng@mssm.edu

Mount Sinai Imaging Research Warehouse (MS-IRW)

What

The Mount Sinai Imaging Research Warehouse (MS-IRW), developed by the BioMedical Engineering and Imaging Institute (BMEII) provides de-identified imaging data along with corresponding health records for over 1 million Mount Sinai patients. The images form the IRW can be linked to de-identified data from the MSDW or visa versa.

How

For more information contact:

Dr. Fayad
Dr. David Mendelson
david.mendelson@mountsinai.org

Neuropathology Brain Bank

What

The Neuropathology Brain Bank CoRE provides a flexible tissue repository platform to facilitate collection, characterization, and distribution of tissues and data for clinical and translational research projects with a neuropathology component.

The Neuropathology Brain Bank provides:

  • Images (gross, photomicographs, and scanned slides)
  • Brain tissue (fresh frozen, fixed, and FFPE)
  • Neuropathology data and reports
  • Assistance with experimental design
  • Consultation services and training

Complete list of brain bank collections – Brain Collections at Mount Sinai

How

Tissues are made available to qualified investigators following internal review.

To access the neuropathology brain bank collection or to discuss other neuropathology services contact:

John F. Crary, MD-PhD
john.crary@mountsinai.org

Human Immune Monitoring Center (HIMC)

What

The Human Immune Monitoring Center (HIMC) in the Precision Immunology Institute offers biospecimen services including:

  • Study design consultations for biospecimen protocols
  • Blood and biospecimen processing
  • Cell sorting and enrichment
  • Biospecimen sample management

How

For more information, refer to the HIMC Biospecimen and Sample Management toggle.

PPHS Guidance - Future Use Data Sharing and Genetic Research

Refer to the PPHS website for guidance and policies on Future Use Data Sharing and Genetic Research.

Patient Recruitment

Patient Recruitment and Study Design

Factors that may affect patient recruitment and retention should be considered during study design. This includes eligibility/ineligibility criteria, procedural burden, endpoints, number of study visits and trial duration.

Learn more about Retention and Recruitment.

Resources

Patient Cohort Identification

The Mount Sinai Data Warehouse (MSDW), Mount Sinai Imaging Research Warehouse (MS-IRW), and Epic (electronic health record system) collect clinical, operational, and financial data from various sources that can be used to support:

  • Study feasibility
  • Study design
  • Patient cohort identification
  • Recruitment

Learn More

Protocol Templates

The PPHS recommends using the NIH template if you are creating your own protocol involving human subjects. The PPHS requires a protocol with most projects coupled with one of the three HRP 503 templates. An example of an NIH template can be found here. Researchers can use their grant application, industry protocol or another version of a protocol providing it has all the necessary elements.

Consent Templates

The Program for the Protection of Human Subjects (PPHS) provides consent templates.

Tools

The NIH web-based clinical trials E-Protocol Writing Tool assists in the collaborative development of protocols for Phase 2 and 3 IND/IDE as well as behavioral and social sciences clinical trials. The e-protocol writing tool uses the NIH-FDA Phase 2 and 3 IND/IDE protocol template as well as the NIH Behavioral and Social Sciences protocol template.

Resources

Collaboration

DIRECT2Experts
CTSA tool providing access to experts across institutions.

PLUMX
Tool to find a MSHS collaborator.

Team Science
Resources to enhance the conduct of interdisciplinary research.

Research 411 Portal

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