Clinical Electronic Data Capture (EDC) System

A Clinical Electronic Data Capture (EDC) System is a domain-specific data capture system that can support a clinical EDC task (for collecting clinical data in electronic format).

• Context:
  • It can (typically) be based on a EDC Platform.
  • It can be integrated or part of a eClinical System.
  • …
• Example(s):
  • an Electronic Clinical Outcome Assessment (eCOA) System such as:
    • an Electronic Patient-Reported Outcome (ePRO) System;
    • an Electronic Clinician-Reported Outcome (eClinRO) System;
    • an Electronic Observer-Reported Outcome (eObsRO) System;
    • an Electronic Performance Outcome (ePerfO) System;
  • an Electronic Clinical Case Report Form (eCRF) System,
  • an Electronic Informed Consent (eConsent) System,
  • an Electronic Health Record (eHR) System,
  • an Electronic Patient Diary (eDiary) System,
  • …
• Counter-Example(s):
  • OCR-based Clinical Data Capture System,
  • Paper-based Clinical Data Capture System,
  • Paper-based Clinical Case Report Form (CRF),
  • Paper-based Clinical Outcome Assessment (COA) Measure,
  • Paper-based Heath Record (HR),
  • Remote Data Entry (RDE) System.
  • a Clinical eSource System.
• See: Direct Data Capture (DDC) System, Clinical Data Acquisition System, Clinical Trials, Contract Research Organization, Graphical User Interface, Data Validation, Report, Medical Device, Informed Consent, Clinical Trial Management System (CTMS), Interactive Voice Response (IVR) System, Software as a Medical Device (SaMD), Optical Character Recognition (OCR) System.

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References

2022

• https://www.altexsoft.com/blog/clinical-trial-software-edc-cdms-ctms-rtsm/
  • QUOTE: ... Electronic Data Capture is a tool for recording and collecting clinical documents. EDCs have CDISC-compliant templates making it easy to design and export eCRFs. EDC systems are the most widely used eClinical tools with the top solutions including Oracle Health Sciences InForm, Medidata Rave EDC, Bioclinica EDC, and many more.

    EDCs can be as complex or as simple as the study team dictates, but in its core, EDC consists of a graphical user interface, a query management module, and a reporting tool. Today, EDC has replaced Clinical Data Management Systems (CDMS) – another acronym that refers to the process rather than to any specific tool. Clinical Data Management is the practice of delivering the best data quality with the least number of mistakes. So basically, EDC is a CDMS, and the terms may be used interchangeably

    Today, clinical studies mostly use EDCs to collect CRFs, but modern solutions can go way beyond that. With the right integrations, EDCs can receive data from apps and medical devices, Electronic Health Records (EHRs) at the hospitals, and ePRO questionnaires. ...

2021a

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Electronic_data_capture Retrieved:2021-12-5.
  • QUOTE: An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).

    Typically, EDC systems provide:

    • a graphical user interface component for data entry
    • a validation component to check user data
    • a reporting tool for analysis of the collected data
  • EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance. EDC can increase data accuracy and decrease the time to collect data for studies of drugs and medical devices. The trade-off that many drug developers encounter with deploying an EDC system to support their drug development is that there is a relatively high start-up process, followed by significant benefits over the duration of the trial. As a result, for an EDC to be economical the saving over the life of the trial must be greater than the set-up costs. This is often aggravated by two conditions: #that initial design of the study in EDC does not facilitate the decrease in costs over the life of the study due to poor planning or inexperience with EDC deployment; and #initial set-up costs are higher than anticipated due to initial design of the study in EDC due to poor planning or experience with EDC deployment. The net effect is to increase both the cost and risk to the study with insignificant benefits. However, with the maturation of today's EDC solutions, much of the earlier burdens for study design and set-up have been alleviated through technologies that allow for point-and-click, and drag-and-drop design modules. With little to no programming required, and reusability from global libraries and standardized forms such as CDISC's CDASH, deploying EDC can now rival the paper processes in terms of study start-up time. As a result, even the earlier phase studies have begun to adopt EDC technology.

2021b

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Remote_data_entry Retrieved:2021-12-12.
  • QUOTE: A remote data entry (RDE) system is a computerized system designed for the collection of data in electronic format. The term is most commonly applied to a class of software used in the life sciences industry for collecting patient data from participants in clinical research studies—research of new drugs and/or medical devices.

    Typically, RDE systems provide:

    • a graphical user interface component for data entry
    • a validation component to check user data
    • a reporting tool for analysis of the collected data

RDE software was started in the mid- to late-1980s as software installed locally on portable computers with modems. It has largely been replaced by a newer generation of software called electronic data capture, or EDC, that provides the same type of functionality over the Internet using web pages.

2021c

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Clinical_data_acquisition Retrieved:2021-12-12.
  • QUOTE: Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems.

    There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial with the exception of the protocol, which specifies the conduct of that clinical trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.

    The ICH guidelines on good clinical practice (GCP) use the term ‘case report form’ (CRF) to refer to these systems. No matter what CRF is utilized, the quality and integrity of the data is of primary importance.

2016

• (Kellar et al., 2016) ⇒ Ed Kellar, Susan M. Bornstein, Aleny Caban, Catherine Calingant, Michelle Crouthamel, Chrissy Johnson, Patricia A. McIntire, Kenneth R. Milstead, Jaclyn K. Patterson, and Brett Wilson (2016). "Optimizing the Use of Electronic Data Sources in Clinical Trials: The Landscape, Part 1". In: Therapeutic Innovation & Regulatory Science, 50(6).
  • QUOTE: Electronic data capture (EDC) systems have become common-place in clinical research in the past decade, largely replacing use of paper CRFs. Consequently, one method of adopting eSource is to use existing EDC systems for data collection without first creating separate source documents. We surveyed member companies regarding their current use of EDC systems. All 13 responding companies reported using one or more EDC systems. In cases where a company reported using more than one EDC system, respondents noted that the decision to use a system for a given study was based on certain factors. Study phase (7 of 11; 63.6%) and sourcing model (5 of 11; 45.5%) were the most frequently reported decision factors. Other reported factors included study size, country, and therapeutic area (TA).

2011

• (Walther et al., 2011) ⇒ Brigitte Walther, Safayet Hossin, John Townend, Neil Abernethy, David Parker, and David Jeffries (2011). ["Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data"]. In: PLoS One. 2011; 6(9): e25348. DOI:10.1371/journal.pone.0025348.
  • QUOTE: Conventional data collection for clinical and scientific trials has focused on paper-based case report forms (CRF) followed by double data entry into a relational database. Recent technological advances and considerable reduction in prices for portable computers make EDC an intriguing alternative. The major advantages of EDC would be the ability to enter, review and analyse data in real-time and to implement online data validation checks to assure data quality more effectively at the point of entry (...)

    There are a plethora of devices suitable for EDC; this study uses three technology types, netbook, tablet PC, and PDA, which are commonly used for EDC. Scanning devices such as smartpen or optical character recognition technologies (...), were not considered in this study (...)

    A major advantage of EDC is that data become available after collection in the field without delay. This enables EDC users to monitor data collection, evaluate the study status and to review and analyse data in real-time.

    So far the literature is mainly descriptive when comparing EDC to the conventional paper method. Analytic studies usually compare the transcription (CRF-to-database) error rates for two different devices such as for example a laptop and a handheld device. This study confirms that after a short period of EDC introduction, electronic data capture can be more time effective than the standard, paper-based data capturing process followed by double entry and verification, although the duration for the interviews using the standard paper questionnaire were shorter compared to the interviews, in which the data was collected electronically.

    The second advantage, which has been described in the literature, that electronic data capture is more accurate than the paper-based method could not be confirmed in this pilot study. Even though the interviewers familiarised themselves with the new data capturing methods very quickly and the overall error rate decreased considerably over time for all EDC. For two EDC methods (tablet PC and netbook) error rates approached those of the standard method, but were never lower. In addition, since the main objective of this pilot study was to test if EDC was feasible and to explore which EDC method (s) proved to be the most suitable for the next step of field studies, range and consistency checks to optimize data quality were not implemented.

2000

• (Waterfield, 2000) ⇒ Emma Waterfield. "4. Data Capture" In: Clinical Data Management. Second Edition, 75-87. Edited by R.K. Rondel, S.A. Varley and C.F. Webb.
  • QUOTE: Traditionally, data capture has meant manual entry of data by trained specialist data entry operators who input data from a paper case record form (CRF) onto a central database via pre-set data entry screens, using a conventional keyboard. Data entry might occur only once (single entry) or successively (double entry), the latter with input by a second, separate data entry operator. Double entry aims to increase accuracy by highlighting the differences between the two operators' versions of the data. Reconciliation between the two entries may be achieved by either of two - methods. On-line data point to data point verification by the second, more experienced data entry operator calls for a judgement to be made between the two conflicting entries, or flagging of the discrepancy for further invetigation by CDM staff. An alternative is to run a report after double data entry which compares the two entries and indicates the inconsistencies. Subsequent comparison of the non-matching variables must then be accomplished by CDM staff before the data are transferred to the production area of the database. This represents an additional, time-consuming step in the data entry process (...)

    The drive to speed up the process by which clinical data are captured onto a centralised database has seen the development of more sophisticated scanning technology. When scanned, each mark on the original CRF page is viewed as a matrix of tiny dots which are stored electronically in the system so that an image can be assessed on a VDU screen rather than printed as a hard paper copy. The improvement over fax technology is that images can be recognised and stored in such a way that the information can later be deciphered. The step by which the optical image is interpreted onto the electronic database is known as automated data acquisition(...)

    Remote data entry means data capture at the point at which it is generated. If electronic transfer of the data to the sponsor's system occurs regularly, the data can be accessed and reviewed much more quickly than has been possible using traditional data capture methods. Crucially, the data can be validated as they are entered, by on-screen prompting, thus minimising errors early on in the process. The incentives for introducing remote data entry are therefore improved data quality, speed and flexibility of access to data, automatic avoidance of simple errors and early notification of error trends, which are all factors that can expedite time to database closure.

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