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 held every Tuesday, from 11 am – 12 pm.
The Accrual to Clinical Trials (ACT) Network
The ACT Network, supported by the National Center for Advancing Translational Sciences (NCATS), is a real-time, open-access platform allowing researchers to explore and validate feasibility for clinical studies using aggregated electronic health record data from over 125M patients nationwide. ACT is free to use for Boston Medical Center and Boston University investigators, HIPAA-compliant and pre-approved by the BUMC IRB, so using ACT does not require study-specific IRB approval. Improving upon other data networks, it offers open-access to a national network of leading academic medical research centers and generates aggregate patient count data from an investigator’s real-time, iterative searches. It allows investigators to check the feasibility of their clinical protocols and to identify potential partner sites for multi-site studies. For more information about the ACT Network, please visit https://www.actnetwork.us/BUCTSI or email email@example.com.
CTSA Consortium Tools
A secure web-based lab management application that allows users to track their frozen samples. Benefits of the tool include:
- Automatic alerts of low number of sample aliquots;
- Sample expiration date; and
- Sample volume or freeze-thaw count along with reporting
FreezerPro has been independently validated and certified to be fully compliant with HIPAA and the FDAs current GLP/GMP requirements. The application is run by BUMC’s IT Department and has full technical support including data and system backups. The centrally subsidized cost is $199 per user per year, a fraction of an individual license.
More information about FreezerPro 2012 Enterprise can be found at FreezerPro.
If you would like to sign up for a license, please call the BUMC IT Service Desk at (617) 638-5914 or submit a ticket to request a license here.
For more information or consultation please feel free to contact us at CTSI Services
GeneHive is a free, secure, flexible, easy-to use, and extensible object storage system designed for the storage and annotation of high-throughput research data. The current implementation contains a suite of data structures designed to encapsulate common concepts such as samples, sample sets, assays, processed datasets, and biomarkers. Contact Adam Gower (firstname.lastname@example.org) for more information.
The BU i2b2 (Informatics for Integrating Biology and the Bedside) is an NIH-funded effort to provide a standardized data architecture and informatics capabilities to combine clinical patient data with demographic, biologic, and genomic data for use in clinical research projects. An easy-to-use aggregate data query tool, i2b is accessible via the internet using the i2b2 web client. The i2b2 framework enables clinical researchers to use existing clinical data for discovery research and, when combined with IRB-approved genomic data, facilitate the design of targeted therapies for individual patients with diseases having genetic origins. Researchers at BUMC and BMC have spent the past 3 years developing and implementing i2b2 to better understand the health and healthcare of Boston’s residents.
Medrio provides browser-based software for data collection in clinical trials (electronic data capture) with no programming. Medrio’s M-edu is a new product free to universities for investigator-initiated or university-funded trials. Medrio users can create, configure, and manage their study themselves.
Other key features include:
- CDASH form and variable libraries
- iPad data entry
- Risk-based monitoring
- Robust data management tools
- eLearning module, comprehensive user guide, and free email support
- Fully HIPAA and 21 CRF part 11 compliant
Medrio is mostly free for academic studies, but there is a charge if your study goes over 100k data points. A data point is one variable such as a number, date, or text field. Total data points are calculated by multiplying each variable by the number of times it is collected per subject, then multiplying by the number of subjects.
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 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.
Protocol Builder is now available at Boston University. Protocol Builder is secure, cloud-based technology that provides step-by-step guidance for developing research protocols. This new protocol writing technology can help you write investigator-initiated protocols that adhere to IRB and regulatory standards in less time with less hassle. It provides organization, guidance, and collaboration tools for your observational or interventional research protocols. Protocol Builder is developed and hosted by BRANY (Biomedical Research Alliance of New York), and can be accessed via your computer or iPad app. Read more about Protocol Builder.
To request access to Protocol Builder, please visit the BU/BMC registration page at https://app.protocolbuilderpro.com/register/boston-university.
Protocol Builder holds live Introductory User Trainings the first Thursday of each month at
5PM ET. To register for the Protocol Builder Introductory User Training on September 5, 2019 5:00 PM ET please see the following link: https://attendee.gotowebinar.com/rt/6637575076468737293.
After registering, you will receive a confirmation email containing information about joining the webinar.
For questions or assistance with Protocol Builder, please contact Mary-Tara Roth, email@example.com.
QDS (Questionnaire Development System) is a system for developing and administering data collection applications that does not require an internet connection and consists of several modules or executable programs (*.EXE).
The first step in creating a QDS application is to define questionnaire specifications in the Design Studio. Your specifications include all content and settings for your questionnaire (e.g., question text, instructions, branching instructions, consistency checks). The Design Studio uses these specifications to build a QDS control file which is then used by the data collection modules to administer your data collection application. The Design Studio is also used to build instrument documentation, including hard-copy questionnaires (self- or interviewer-administered), an analytical codebook, and a log of all changes made to your specifications file (change history).
Data Collection Modules
QDS supports both manual and computer-administered data collection. Each type of data collection (Data entry, ACASI, CAPI, HAPI, and QDS-Web) is associated with its own data collection module. These modules create data files in a binary file format that may be converted to a flat ASCII file using the Questionnaire Data to ASCII conversion utility (QDA.EXE) or exported to SAS, SPSS, or MS Access using the QDS Warehouse Manager.
- Data entry: The QDS data entry module is used to key data originally collected on a paper form and supports double entry (also called key verification or double keying) for increased quality assurance.
- CAPI (computer-administered personal interview): The QDS CAPI module allows interviewers to conduct face-to-face interviews using the computer. The computer displays one question at a time and allows the interviewer to enter responses in real time using the keyboard, mouse, and/or touch screen. Entering the data into the computer at the time of data collection eliminates the need for a separate data entry step. The CAPI module allows you to include information/probes for the interviewer.
- ACASI (audio computer-administered self-interview): The QDS ACASI module allows the respondent to be “interviewed” by computer. The computer displays one question at a time and allows the respondent to enter responses using the keyboard, mouse, and/or touch screen. You may choose to have the computer read the questions and responses to the respondent using a computer text-to-speech engine or recorded WAV files. Entering the data into the computer at the time of data collection eliminates the need for a separate data entry step. Because no interviewer is required to conduct an ACASI interview, use of ACASI allows a single staff member to supervise multiple interviews. ACASI is also useful for providing a private setting for sensitive information. With the QDS ACASI module, you have several options for generating audio. You can use the DEC talk text-to-speech engines, WAV file recordings of human voice, or a combination of computerized text-to-speech and WAV files in a single questionnaire. The DEC talk text-to-speech engine comes bundled with the ACASI program and supports English (American and UK), Spanish (Castilian and Latin American), French and German.
- HAPI (handheld-assisted personal interview): A HAPI module is available for conducting interviews on a pocket PC device. The HAPI program includes all features available in CAPI and is fully integrated into the QDS system. Using Microsoft ActiveSync, QDS users can install the HAPI program on their pocket PCs and move HAPI control and data files back and forth between the desktop and handheld devices.
- QDS-Web: the newest data collection module within the QDS suite, QDS-Web was developed to allow researchers to design, develop, and deploy complex research survey instruments on the Internet. To learn more about QDS-Web please visit the QDS-Web website.
Once data are collected/recorded, users may import the data into the warehouse manager for data management and export data for analysis. This enables users to track the status of collected data and, for multi-site studies, whether each completed questionnaire has been shipped to and received by the data Coordinating Center. The warehouse manager also allows export of QDS questionnaire data to SPSS, SAS, Stata, or MS Access database formats for analysis and reporting.
If you would like more information about programming for QDS, please contact Tasha Coughlin, firstname.lastname@example.org.
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 email@example.com.
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 firstname.lastname@example.org or (617)-358-1111 option 3.
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):
- Education & Training
- 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.
- 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 email@example.com.
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:
- 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!
- Publish Faster
- 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.
- Same Day Solutions
- 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.
- Flexible Partnership
Additional product details can be found at Studytrax.com.
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.
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 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 firstname.lastname@example.org.