A 21 CFR Part 11 Compliant Graphically Based Electronic System for Clinical Research Documentation

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

doi:10.1007/s10916-010-9627-4

Cited by 6 publications

(6 citation statements)

References 1 publication

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“…The use of queries can then be implemented in software applications to create a custom interface for the retrieval of data. Previous implementations by this site included a network share with pdf files titled with defined identifiers, allowing the user to find required documents [7]. However, this method required that the user browse a directory system populated with user defined folders to add more identifying information.…”

Section: Discussionmentioning

confidence: 99%

A Facilitated Interface to Generate a Combined Textual and Graphical Database System Using Widely Available Software

Lawson¹,

Larson²,

Erdewyk³

et al. 2012

JSEA

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Data-Base Management System (DBMS) is the current standard for storing information. A DBMS organizes and maintains a structure of storage of data. Databases make it possible to store vast amounts of randomly created information and then retrieve items using associative reasoning in search routines. However, design of databases is cumbersome. If one is to use a database primarily to directly input information, each field must be predefined manually, and the fields must be organized to permit coherent data input. This static requirement is problematic and requires that database table(s) be predefined and customized at the outset, a difficult proposition since current DBMS lack a user friendly front end to allow flexible design of the input model. Furthermore, databases are primarily text based, making it difficult to process graphical data. We have developed a general and nonproprietary approach to the problem of input modeling designed to make use of the known informational architecture to map data to a database and then retrieve the original document in freely editable form. We create form templates using ordinary word processing software: Microsoft InfoPath 2007. Each field in the form is given a unique name identifier in order to be distinguished in the database. It is possible to export text based documents created initially in Microsoft Word by placing a colon at the beginning of any desired field location. InfoPath then captures the preceding string and uses it as the label for the field. Each form can be structured in a way to include any combination of both textual and graphical fields. We input data into InfoPath templates. We then submit the data through a web service to populate fields in an SQL database. By appropriate indexing, we can then recall the entire document from the SQL database for editing, with corresponding audit trail. Graphical data is handled no differently than textual data and is embedded in the database itself permitting direct query approaches. This technique makes it possible for general users to benefit from a combined text-graphical database environment with a flexible non-proprietary interface. Consequently, any template can be effortlessly transformed to a database system and easily recovered in a narrative form

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Section: Discussionmentioning

confidence: 99%

A Facilitated Interface to Generate a Combined Textual and Graphical Database System Using Widely Available Software

Lawson¹,

Larson²,

Erdewyk³

et al. 2012

JSEA

Self Cite

View full text Add to dashboard Cite

show abstract

“…One tool is therefore easily deployed on iPads and laptops, which are our primary computing devices. ConnEDCt’s features, quality, and safety are reliable compared with existing guidelines and requirements, including Good Clinical Data Management Practices [ 8 ], the Food and Drug Administration (FDA) [ 9 ], and Title 21 Code of Federal Regulations (CFR) Part 21 [ 10 ].…”

Section: Methodsmentioning

confidence: 99%

An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation

Ruth¹,

Huey²,

Krisher³

et al. 2020

J Med Internet Res

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Background When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador. Objective This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs. Methods We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage. Results ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection). Conclusions ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

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“…We also developed a test plan based on these specifications to justify validation of the mEDC system. In order to ensure regulatory compliance, we referred to three additional guidelines focusing on EDC systems for RCTs while designing mEDC: Good Clinical Data Management Practices proposed by the Society for Clinical Data Management (SCDM) [10], Guidance for Industry Computerized Systems Used in Clinical Investigations represented by the Food and Drug Administration [11], and Guidance for Industry Part 11 of Title 21 of the Code of Federal Regulations on Electronic Records and Electronic Signatures (21 CFR 11) [12]. Before implementing the primary study, we invited two independent research staff to validate the mEDC system.…”

Section: Methodsmentioning

confidence: 99%

“…As part of the study SOP, doctors were required to click a photograph of the page with signatures and submit it to the server, which could help CRAs verify patients’ recruitment because signatures of patients and doctors were essential as per the recommendations of 21 CFR 11 [12]. …”

Section: Methodsmentioning

confidence: 99%

Mobile Device–Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges

Zhang¹,

Sun²,

Liu³

et al. 2017

J Med Internet Res

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BackgroundElectronic data capture (EDC) systems have been widely used in clinical research, but mobile device–based electronic data capture (mEDC) system has not been well evaluated.ObjectiveThe aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT).MethodsWe developed an mEDC to support an RCT called “Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)” study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes.ResultsThe mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study.ConclusionsThe innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial.

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A 21 CFR Part 11 Compliant Graphically Based Electronic System for Clinical Research Documentation

Cited by 6 publications

References 1 publication

A Facilitated Interface to Generate a Combined Textual and Graphical Database System Using Widely Available Software

A Facilitated Interface to Generate a Combined Textual and Graphical Database System Using Widely Available Software

An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation

Mobile Device–Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges

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