Develop Your Study

How to write a research protocol

The Clinical Research Writing Education Series on the Clinical Trials Network Best Practices Site offers a six-lecture series addressing writing manuscripts, abstracts for manuscripts and meetings, protocols, and successful grant applications. This is for investigators and staff with limited formal training in clinical research writing.

Office of Clinical Research

Division of Biostatistics and Data Management - In the design phase, Division biostatisticians and programmers guide study investigator choices regarding sample size, power calculations, and data collection instruments. In the design phase, Division biostatisticians and programmers guide study investigator choices regarding sample size, power calculations, and data collection instruments.

Rapid Database Generator^© (RDG) – This Mount Sinai developed toolset allows for the rapid development and delivery of secure custom databases in support of single and multi-site clinical and basic science research. Using SQL and ASP.net, databases built using the RDG are stored, backed up and maintained in Mount Sinai’s secure data center environment. In addition, role and location based security features facilitate the use of this tool in designing large, multi-site studies. The RDG databases are integrated with Medicine’s BioExper™ Laboratory Information Management System (LIMS) to support de-identified specimen management as part of research projects. The custom report generator tool allows the research team to create and manage reporting and extraction of all data elements defined in their database with minimal training.

InfoEd Clinical Trials Module – Working with the Office of Clinical Research, this toolset has been implemented to support the administration and management of single and multi-site clinical trials. This module includes functionality for protocol design, patient enrollment with inclusion/exclusion criteria, visit schedule management, billing reconciliation, custom Case Report Form builder, Adverse Event management and reporting, contract management and regulatory binder management.

Electronic Research Application Portal © (eRAP) – This secure web portal serves as the delivery mechanism for the RDG and InfoEd databases as well as other custom links required to support projects. Using eRAP, your research team can manage data in accordance with their role-based security from wherever they are.

Mass Storage Area Network – Mount Sinai has implemented a fully redundant multi-terabyte SAN to provide large-scale data storage for active research projects. This SAN is located in Mount Sinai’s secure data center and receives all data center support including backup, maintenance and disaster recovery.

Budget Development – Staff are available to work with investigators during the budget development phase of their grant application process to identify technology and data management requirements to include in project budget requests.

Pharmacy Consultation – Consultation with the Pharmacy’s Investigational Drug Service (IDS) for studies that involve procurement, preparation, storage, labeling (etc.) of drugs or biologics should occur at the proposal development stage. The IDS staff will assist in providing information about feasibility and resource requirement.

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