CRCU/CCEB – Oracle/REDCap/Veeva
At the start of the study the research team should determine what data management tool will be used to support the trial. The majority of studies conducted at Penn will be done so using an electronic data capture (EDC) system for housing study case report forms (CRFs). For externally sponsored trials, typically, the sponsor will dictate what system should be used. For investigator-initiated Penn trials there are variety of options that may be used and are detailed below. While paper remains an option, it is not recommended as it does not lend itself to any remote work capabilities and makes submissions to regulatory authorities, off site monitoring, etc.
Below is a depiction of the data management options available at Penn.
Learn More About Each Application:
Penn Medicine REDCap
Veeva Electronic Data Capture (EDC)
Vault EDC is intended for studies in need of a 21 CFR part 11 compliant data capture for more complex or multi site trials. The tool is intended for trials with multiple arms, cross over, randomization or advanced logic and rule functions. It also has the ability to integrate and report on data across multiple sources both internal and external to Penn. The tool is designed to have no down time even for studies with adaptive and dynamic designs. This tool is supported in a fee for service central model by the Clinical Research Computing Unit (CRCU). Additionally you may contact OCR if you are interested in discussing and taking vendor led training to get access.
Data Management/ Data Coordinating
In need of data management services or a full Data Coordinating Center function, contact the Clinical Research Computing Unit. The CRCU provides expertise in project management, data coordination and research computing tailored to meet your project requirements. The CRCU project teams partner with the BAC in the project design phase to plan accurate and precise data collection modules and to structure project reports for steady oversight.
What is 21 CFR Part 11 and does it Apply to my Study?21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
The first step in becoming compliant with the regulations is to determine whether or not you are required to be compliant. The following questions can help lead to the determination:
- Is your clinical trial conducted under an approved IND? If yes, electronic system needs to meet part 11
- Is your clinical trial conducted under an approved IDE? If yes, electronic system needs to meet part 11
- Does your grant specify that your computer systems must comply with 21 CFR Part 11 or similar requirements? If yes, electronic system needs to meet part 11
If you answered yes to any of these questions, your electronic systems of record that are being used to meet predicate rules are required to comply with 21 CFR Part 11. Your sponsor may provide you with a system to use. The two options available at Pen Medicine are Penn CMTS and Veeva Vault EDC.
The Clinical Research Computing Unit (CRCU) is a fee for service data coordinating center at Penn. For investigator initiated studies, the PI is responsible for the data management conduct during the study. The CRCU can conduct case report form development (CRF) and design, database design and build and lifecycle data management. They also can assist with determining which database is most appropriate for a study to use as well as ongoing data quality assurance.
More about the resources they provide can be found on the CCEB CRCU resources page.
For a quote, you may contact Florence Speiser, M.S.