The EDC Support service helps coordinate, lead and support faculty and research study staff in their electronic data capture (EDC), web-based survey and application needs for research studies. EDC Support will help identify the optimal study tool given the investigator’s requirements and facilitate the training of personnel in its uses and functions.
In collaboration with the Harvard Catalyst | The Harvard Clinical and Translational Science Center, REDCap (Research Electronic Data Capture) is a free, secure, HIPAA compliant web-based application hosted by Partners HealthCare Research Computing, Enterprise Research Infrastructure & Services (ERIS). Vanderbilt University, with collaboration from a consortium of academic and non-profit institutional partners, develops this software application for electronic collection and management of research and clinical study data. Data collection is customized for each study or clinical trial by the research team with guidance from ERIS REDCap administrators.
REDCap is built around HIPAA guidelines and is 21 CFR Part 11 capable. Please see our knowledge base article on compliance for more information about these regulations.
REDCap Getting Started knowledge base has video tutorials and guidelines on how to access REDCap, request, design and maintain your projects.
New! REDCap Project Templates: Electronic / Paperless Consent and Certified Copies
- Informed Consent obtained via paper then scanned to electronic certified copy
- PHRC Guidance for Electronic Storage of Research Documents
- REDCap HOW TO: Scan and Store Research Documents in REDCap
- Informed Consent where a computer/device can be substituted for paper; study team interaction is same as paper process; also know as Paperless Consent or eConsent
- NOTE: This is a Handwritten Signature applied to electronic media (21 CFR Part 11 Training 25 Oct 2017 )
- REDCap HOW TO: REDCap eConsent / Paperless Consent
REDCap: RPDR and eCare Data Import Assistant
Partners Enterprise Research IS, the Research Computing Core and EDC Support are developing tools to allow users who have access to RPDR (Research Patient Data Registry) and Partners eCare data to more easily import that data into REDCap.
Mmore information is available on every REDCap project's Application List as "RPDR Data Import Assistant". Review the FAQ
Do you have RPDR or EPIC Integration Needs? We are gathering requirements for future initiatives. Please complete this survey to help guide our development.
REDCap's stream-lined process for rapidly developing databases, requires little database design experience. REDCap provides a user-friendly interface to program web-based case report forms with real-time data entry validation (e.g. for data types and range checks).
Advantages of REDCap over MS Excel, Access and some other online survey tools:
- Secure and web-based - Input data from anywhere in the world with secure web authentication, data logging, and Secure Sockets Layer (SSL) encryption.
- Hosted at Partners DIPR Datacenter - No need to worry about security issues regarding third party websites hosting your private data.
- Fast and flexible - Conception to production-level database timeline determined by study team.
- Multi-site access - Projects can be used by researchers from multiple sites and institutions.
- Fully customizable - You are in total control of shaping your database or survey.
- Advanced question features - Auto-validation, branching logic, piping, and stop actions.
- Mid-study modifications - You may modify the database or survey at any time during the course of your study.
- Data import functions - Data may be imported from external data sources to begin a study or to provide mid-study data uploads.
- Data comparison functions - Double data entry / Blinded data entry.
- Export results to common data analysis packages: Microsoft Excel, SAS, Stata, R, or SPSS for analysis.
- Save your survey or forms as PDFs - Generate a PDF version for printing in order to collect responses offline.
REDCap Core Services
Need additional support?
ERIS Research Core offers supplemental services for REDCap:
- Review data collection forms to support efficient data entry
- Make recommendations on data modeling and data entry screens
- Program and test data entry screens to yield appropriate data sets for planned statistical analyses
- Plan patient tracking and scheduling systems
- Program feature extensions: plugins and hooks
The REDCap Report FY17
An EDC system (studies, surveys, patient registries) built completely around helping investigators generate output (e.g., manuscripts).
Survey and Study EDC:
Deliver dramatic productivity gains via work-flow innovation, top-notch engineering, and intuitive design.
StudyTrax is hosted by Partners Research Computing and is available to all researchers with a licensing agreement from ScienceTRAX. Request additional information from ScienceTRAX or EDC Support.
Student License $99
Pilot Data Grant Program $99
Advantages of StudyTRAX versus other EDC
- The StudyTRAX feature set is much more mature, better designed, easier to implement and in-depth as compared to other tools, and StudyTRAX is loaded with a numerous time-saving features simply NOT found anywhere else (e.g., integration of manuscript generation process).
- Immediately apparent upon comparison, the StudyTRAX user-interface is exceptionally polished, intuitive and easy-to-use.
- Customer support is responsive, helpful and overall second-to-none. Much could be said about support, but said best by asking any StudyTRAX user.
Streamlined Data Analysis And Academic Output Process:
Complete integration of manuscript / report generation process, dynamically linked to data!!
- Across study reporting without programming, point-and-click interface
- Build tables and charts that are dynamically updated on demand
- File management
- Organize all academic output and reports within or across studies, surveys, or patient registries.
- Flexible data set layout and export options
- Include raw, re-coded, transformed, and calculated variables
- Integrated automated dose equivalency calculation
- Numerous data consolidation methods, query and filter options
- Organize data clean/scrubbing process
- Descriptive statistics
- Visualize variable value distributions
- Numerous validation routines
Dynamic Subject Portal / Survey Management:
Full integration of study and survey functionality.
- Subjects can enter data AND automatically receive powerful, multimedia reports and educational materials dynamically linked and customized to their data.
- Completely define your own subject website (e.g., layout, look and feel, content) for what subjects see before AND after they login.
- Automated email communication and reminders.
- Broad range of enrollment options (e.g., subjects register and create their own accounts versus research staff create accounts).
Flexible configuration for a broad range of study designs, surveys and patient registries.
- Integrated randomization, ID generation.
- Screening visits.
- Centralized calendar across studies.
- Automated subject reports with conditional and logic-driven text (e.g., AE reports, clinic notes)
- Complete integration of query process.
- Central list of medications, automated dose equivalency scales, all woven into data sets.
- Data import wizard from Excel.
Integrated User Portals And Study Website(s)
- Complete integration and management study website(s), determine what users see both before and after login.
- Design, create and manage user portals (e.g., study safety monitoring board, randomization).
No limits on layout design, content or use of multimedia tools, images, sound, etc.
- Forms look exactly like paper CRF.
- Computer validated, opposed to manual, completion status.
- Within and across form validation and skip logic.
- Double Data Entry with multiple roles, reports and link to data set options.
- Form versioning capability.
- Sophisticated data entry concurrency management (i.e., two users entering data at the same time).
The system combines the power and flexibility of a user-driven freezer management system with the solid foundation of a relational database. Researchers can subscribe to the service at a discounted rate through the Research Computing Core.
- Centrally hosted by Partners with daily backups
- Tracks what is being stored, moved, thawed and tested
- View sample inventory
- Provides batch data entry and update records
- Offers numerous options for viewing and exporting data
- Is able to print bar code labels and ship samples to outside organizations
- Controls access to data on an authorized user, per lab basis
- Provides a complete audit trail that complies with 21 CFR Part 11
More about Freezerworks: http://www.freezerworks.com/
- Annual subscription service fee
- Visit our Research Computing Core Fees page for pricing information (Login Required)
- Interested in using Freezerworks, please complete a brief online form
- After reviewing your request we will schedule a follow-up meeting.
- To access the software, your device must be connected to the Partners Network.
Starting October 1, 2016: Enterprise Research Infrastructure & Services, ERIS, manages an enterprise license for LabArchives.
LabArchives is a web-based application designed for scientists to organize and share laboratory data within their study team, department, or external collaborators. A LabArchives Notebook may be shared among any number of users; access rights are controlled by the notebook owner and can be easily modified to suit the individual needs of each researcher, educator, or contributor.
Replacing paper lab notebooks with ELNs has many advantages: ELNs streamline the documentation and protection of intellectual property, help scientists collaborate, and make scientific data and observations associated with experiments easier to search, find and use.
LabArchives Knowledgebase: Search general, getting started, and feature specific information.
Introduction to LabArchives: Every Thursday at 1pm EST - REGISTER
Introduction to Widgets: To schedule a personalized webinar training on widgets, contact email@example.com
LimeSurvey at Partners:
LimeSurvey is a free, web-based application hosted by Partners HealthCare Research Computing, Enterprise Research Infrastructure & Services (ERIS). It is an open source software package Copyright © 2003 onwards by Carsten Schmitz with portions contributed/copyrighted by many others and all of it is provided under the terms of the General Public License GPL. LimeSurvey is used for research, clinical, academic, and operational data collection. Data collection is customized for each study or clinical trial by the research team.
Important Service Notification:
Due to increased Partners HealthCare Information Security requirements and standards, ERIS is working towards transitioning LimeSurvey users to other secure platforms like REDCap. We are no longer issuing new project accounts. We plan to decommission the service by end of FY2018: Oct. 1 2018.