A 21 CFR part 11 compliant graphically based electronic system for clinical research documentation

Ashley Bansal, Richard Chamberlain, Sean Karr, Sassen Kwasa, Bryan McLaughlin, Bao Nguyen, Marc Rendell, Kayla Schmit, Chris Smith

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Clinical research protocols are intricate and detailed. Regulatory authorities including the U.S. Food and Drug Administration require full documentation of all procedures, including who performed them and when they were performed. Paper based study records are becoming ever more voluminous as the requirements for detailing every item continue to grow. Although the current approach is to transfer required data to electronic databases, each protocol requires uniquely designed databases. Therefore, at present, it has not been possible to design generalized electronic databases which serve for each individual study which can serve as primary source documentation. We have taken a new approach, by developing an electronic graphically based source documentation technology which in every way mimics and maintains the advantages of paper recordkeeping. We use tablet computers as paper surrogates, feeding data archives maintained on central servers. Our system uses widely available non-proprietary components and programs. We meet the requirements enunciated by the US Food and Drug Administration for electronic systems. These include requirements to maintain data integrity, backup of data, validation of all system components, safeguards on digital signatures, and a date and time stamped audit trail. This system has been used by our group successfully for more than 2 years encompassing over 20 pharmaceutical research studies.

Original languageEnglish
Pages (from-to)1661-1672
Number of pages12
JournalJournal of Medical Systems
Volume36
Issue number3
DOIs
StatePublished - Jun 2012

Fingerprint

Documentation
Databases
United States Food and Drug Administration
Research
Handheld Computers
Network protocols
Electronic document identification systems
Data transfer
Clinical Protocols
Drug products
Servers
Technology
Pharmaceutical Research

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Health Informatics
  • Health Information Management
  • Information Systems

Cite this

Bansal, A., Chamberlain, R., Karr, S., Kwasa, S., McLaughlin, B., Nguyen, B., ... Smith, C. (2012). A 21 CFR part 11 compliant graphically based electronic system for clinical research documentation. Journal of Medical Systems, 36(3), 1661-1672. https://doi.org/10.1007/s10916-010-9627-4

A 21 CFR part 11 compliant graphically based electronic system for clinical research documentation. / Bansal, Ashley; Chamberlain, Richard; Karr, Sean; Kwasa, Sassen; McLaughlin, Bryan; Nguyen, Bao; Rendell, Marc; Schmit, Kayla; Smith, Chris.

In: Journal of Medical Systems, Vol. 36, No. 3, 06.2012, p. 1661-1672.

Research output: Contribution to journalArticle

Bansal, A, Chamberlain, R, Karr, S, Kwasa, S, McLaughlin, B, Nguyen, B, Rendell, M, Schmit, K & Smith, C 2012, 'A 21 CFR part 11 compliant graphically based electronic system for clinical research documentation', Journal of Medical Systems, vol. 36, no. 3, pp. 1661-1672. https://doi.org/10.1007/s10916-010-9627-4
Bansal, Ashley ; Chamberlain, Richard ; Karr, Sean ; Kwasa, Sassen ; McLaughlin, Bryan ; Nguyen, Bao ; Rendell, Marc ; Schmit, Kayla ; Smith, Chris. / A 21 CFR part 11 compliant graphically based electronic system for clinical research documentation. In: Journal of Medical Systems. 2012 ; Vol. 36, No. 3. pp. 1661-1672.
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