Data Management Unit Comprehensive and Customized Data Management Services
The Data Management Unit (DMU) provides comprehensive and customized data management services for research studies conducted by University of Pennsylvania investigators and their collaborators without FDA compliance, training, or regulatory requirements. These services include:
- Project Start-Up
- Time line/project plan definition and management.
- Translation of study protocol data management elements into a data management plan and database design.
- Forms Development and Printing
- Development of Case Report Forms (CRFs), patient surveys, and other research forms using Cardiff TeleForm software.
- Specification and documentation of source materials.
- Assistance with development and maintenance of a data dictionary.
- Facilitation of obtaining license agreements for proprietary research forms (e.g., SF-36 Health Survey).
- CRF, patient survey, and research form printing, featuring a pre-populated study ID and visit ID on each page of each form.
- Data Entry and Processing
- Development of Case Report Forms (CRFs), patient surveys, and other research forms using Cardiff TeleForm software.
- Specification and documentation of source materials.
- Assistance with development and maintenance of a data dictionary.
- Facilitation of obtaining license agreements for proprietary research forms (e.g., SF-36 Health Survey).
- CRF, patient survey, and research form printing, featuring a pre-populated study ID and visit ID on each page of each form.
- Data Cleaning
- Initiation of data queries to research staff to clarify or confirm specific data elements with study subjects.
- Documentation of ranges, response frequencies, and other distributional summaries either for selected fields.
- Modification of raw data files to include corrections identified by study staff.
- Development of a Customized Patient Recruitment Tracking System
The scope of services provided by proposed DMU does not include the following:
- Serving as Data Coordinating Center for multi-center Randomized Clinical Trials.
- Providing data management support for projects requiring FDA compliance.
- Providing any level of regulatory or compliance training, coordination, or consultation.
- Research Network development and management.
- Filing of investigator-initiated INDs/IDEs.
- Safety reporting to U.S. and international regulatory authorities.
- Development of web based multi-site data entry systems.
