Study Design and Data Tools

Investigators are strongly encouraged to consult with the Study Design and Biostatistics Core, which provides FREE consultations to those planning to conduct or currently conducting clinical or translational research. Drop-in sessions for study design and statistical analysis consultation are currently being held.

ENACT Network
The ENACT is the largest federated network for regulatory-compliant EHR-based research.  ENACT is a multi-center, real-time, open-access platform that allows researchers to explore and validate feasibility for clinical studies using aggregated electronic health record data from over 125M patients nationwide. Investigators are able to query the network in real-time and to obtain aggregate counts of patients who meet clinical trial inclusion and exclusion criteria from U.S. sites. The ENACT network infrastructure provides a basis for cohort discovery and for developing new informatics tools to identify and recruit participants for multi-site clinical trials.
ENACT Enables:

  • Regulatory-Compliant EHR Based Research
  • Improved Data Quality
  • Access to Trainees for Educational Purposes
  • AI and Machine Learning Analysis to Large Scale EHR Data Sets
  • Informatics Experts to Develop and Validate New Tools
  • Clinical Decision Support
OpenSESAME

OpenSESAME (Search of Expression Signatures Across Many Experiments) is a web-based tool for using patterns of gene expression to discover relationships between experimental conditions, diseases, or biological states. openSESAME is unique in that it identifies connections between datasets based on expression patterns alone, without the need for prior knowledge of experimental groups or phenotypes. To learn more please visit Bioinformatics.

Profiles
Profiles is a software tool that supports research networking and expertise searches by enabling users to locate researchers by subject matter, name, institution, department, division, faculty, etc. To learn more please visit BU Profiles.
Qualtrics

A premier online survey tool, Qualtrics enables users to send and track participation invitations and reminders, display survey results in real time, graphically and statistically, and export raw data in a variety of formats (to CSV, SPSS, XML, HTML, and SAS). 

Other key features include:

  • Libraries of customizable templates and question banks that can be shared by users and groups (collaboration with colleagues keeping your data safe and secure).
  • A quick survey builder guide for beginners.
  • Survey translation capabilities, allowing respondents to select a language or default to a browser language preference and tracking those selections in survey results.
  • Continuous file saving, minimizing potential data loss due to browser crashes.
  • Folders for survey organization.
  • Ability to easily insert graphics and video into surveys
  • Advanced logic and piping

Tutorials, webinars, ebooks, and help documentation are available from Qualtrics including a tutorial on Learning Qualtrics in Five Steps. Complete project configuration can be provided for a fee, for information please contact Tasha Coughlin at tawatson@bu.edu.

To use a BU Kerberos login or Guest Account please click here. https://www.bu.edu/tech/services/cccs/desktop/distribution/qualtrics/
If a BUMC community member is having trouble accessing or having a Qualtrics issue, they can contact BUMC IT at bumchelp@bu.edu or (617)-358-1111 option 3.

Login to BU Qualtrics
Access training classes and tutorials

ResearchMatch
  • ResearchMatch is a nonprofit program funded by the National Institutes of Health (NIH). It helps connect people interested in research studies with researchers from top medical centers across the U.S.
  • Get connected to research on many different health conditions – through ResearchMatch
REDCap

REDCap (Research Electronic Data Capture) is a secure web-based application for electronic data capture (EDC) and data management. REDCap was created at Vanderbilt University and is primarily for research and quality improvement studies.

REDCap allows end users to build online databases and surveys, accessible to collaborators and participants, respectively, with real-time data quality checks, queries, and reporting. REDCap production projects have audit logs of user activity, data changes, and a history of revisions, helping to prevent unwanted changes or data loss. REDCap features include data exports to Excel and statistical packages (SPSS, SAS, Stata, and R), longitudinal scheduling, e-consent, multi-language management, branching logic, and calculated fields.

The BU REDCap server has security features required to allow the system to collect, process, and store data classified as Restricted Use. The BU REDCap configuration includes a virtual Restricted Use environment (vRU), a firewall, SSL/TLS encryption, two-factor authentication, and user rights management policies to enhance security and compliance.

BU REDCap is supported by the BUMC IT REDCap Application Client Service and is covered under the IS&T Server Backup & Restore Service, https://www.bu.edu/tech/services/infrastructure/storage-backup/server-backup/. Backups are stored in IS&T’s primary data center and retained for 30 days. Backups are for complete database retrieval, not project-level restoration (i.e., record data should not be deleted unless externally archived and approved to do so).

The BU REDCap application may be used for the following purposes (any other unspecified use requires approval):

  1. Research
  2. Education & Training
  3. Quality Improvement*
    *New quality improvement (QI) and quality assurance (QA) initiatives (clinical and non-clinical), designed to evaluate and improve quality and performance in processes, guidelines, and training and education, for a BU/BMC community or clinical area.
  4. Operational Support*
    *Restricted to BU operational support only. BU Business Associate services restrict BMC from using BU REDCap for BMC’s operational support (e.g., tracking specific information to support day-to-day BMC operations, programs, or business models [e.g., daily administration of business and staff management, and financial and legal activities]).

If you are conducting a drug or device study under an IND/IDE or plan to submit your data to the FDA, and you are seeking to use BU REDCap for any data collection, including e-consent, you must comply with FDA 21 CFR Part 11 requirements for electronic records and signatures. Please complete the BU REDCap Part 11 Request Form to get started.

For information regarding BU REDCap user access and support, please email REDCap support at rchelp@bu.edu.

REDCap Request for Access & End User Agreement
BU REDCap Login Page

SMART IRB
Smart IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy
Studytrax

Studytrax is an electronic data capture system designed to manage surveys, patient registries, clinical trials, and other research designs (learn more).

The benefits of Studytrax include:

  1. The Application
    • Publish Faster
      • What if it was simple to query, extract, visualize and analyze data, and publish the end-results?
      • Studytrax sets the bar in investigator productivity by completely integrating the analytical / manuscript generation process.
    • Manage More
      • What if the workflow, tasks, data entry and management of multiple studies could be coordinated within a single, integrated environment?
      • Studytrax combines ease of scalability with a powerful set up reporting features to make management of multiple studies simple.
    • Retain Longer
      • What if subjects were engaged and motivated to participate in studies?
      • Studytrax dramatically reduces dropouts and missing data through a portal that supports data entry, plus delivers rich, personalized content and incentives!
  2. The Support
    • Same Day Solutions
      • The overwhelming majority of questions are solved the same day.
    • Up And Running
      • Instant, cloud-based user access and easy setup process.
    • Accessible Answers
      • Leverage a wealth of online resources or schedule 1-on-1 assistance.
  3. The Relationship
    • Flexible Partnership
      • Accustom to the challenges of academic research, and adaptive to funding, requirements and timeline changes.
    • Long-Term Perspective
      • Partnering with investigators to produce superior projects throughout their research career.
    • Institution Trusted
      • Vetted by Partners’ Research Information Science & Computing (RISC) for secure, compliant research use.

Additional product details can be found at Studytrax.com.

TELEforms

TELEforms software is optimal for users who prefer paper forms when collecting data or don’t have the time or personnel to perform data entry. Used to develop scanable data collection forms, TELEforms maps each data point directly to a database. The software is used to read the forms, verify the accuracy of the data, and save the data and an image of the submitted form. Forms can be scanned directly into the system, or submitted by fax or file upload. This resource is offered on a fee-for-service basis.

If you would like more information about TELEforms, please contact SPH BEDAC, BEDACprp@bu.edu to evaluate whether TELEforms would be appropriate for your project and receive a cost estimate.

Trial Innovation Network
Trials Today
To end disease tomorrow, begin with Trials Today.
Whether you are looking for treatment, or want to help out with research that will improve treatment, diagnosis, and prevention, there are studies that need you.
We know figuring out where to start can be the hardest part about finding research studies you might like to join. That’s why we’ve made it easier for you to find the information you need. We made a quick way to search the thousands of studies available on ClinicalTrials.gov. By answering a few short questions, we can help you find a list of studies that may interest you.
ClinicalTrials.gov is a database of federally and privately supported clinical trials conducted in the United States and around the world. This information should be used in conjunction with advice from health care professionals. To search for clinical trials please follow this link.
TriNetX
TriNetX is a cloud-based informatics platform that allows users to analyze aggregate patient populations and facilitate clinical research, study design and clinical trial recruitment. Investigators at Boston Medical Center and Boston University have access to BMC’s de-identified patient data through a self-service, user-friendly interface and state-of-the-art visualization and analytic functions. TriNetX helps investigators explore patient populations in depth and demonstrate study feasibility in funding proposals and IRB submissions. TriNetX is free to use, HIPAA-compliant, and pre-approved by the BUMC IRB, so using TriNetX does not require study-specific IRB approval. To find out more about TriNetX, please visit https://www.trinetx.com or email nst5775@bu.edu.
WebCAMP