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.
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.
REDCap is not part 11 compliant but is part 11 capable. This means the system has the functions to meet part 11 but has not been validated. If you are going to use REDCap you can find ways, in the REDCap section of the site, to run your trial as closely as possible in accordance with part 11. However, you should make it clear to your sponsor that the system is not part 11 at the institutional level. REDCap is best used for studies not under an IND or IDE.
Penn CTMS : Click HERE to get re-directed to the PennCTMS section of the OCR website
Veeva Vault EDC
Veeva Vault EDC is a new product at Penn. If you are interested in using the application, please contact the central OCR email box. To learn more about Veeva as a product you may search here
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