Electronic Data Capture
Encyclopedia
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.
Typically, EDC systems provide:
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
, although some EDC system's such as SciAn Services edcpro are specialized to include tools for phases I-II.
EDC can increase the 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: 1) 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 2) 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.
Clinical research data—patient data collected during the investigation of a new drug or medical device is collected by physicians, nurses, and research study coordinators in medical settings (offices, hospitals, universities) throughout the world. Historically, this information was collected on paper forms which were then sent to the research sponsor (e.g., a pharmaceutical company) for data entry into a database and subsequent statistical analysis environment. However, this process had a number of shortcomings:
To address these and other concerns, RDE systems were invented so that physicians, nurses, and study coordinators could enter the data directly at the medical setting. By moving data entry out of the sponsor site and into the clinic or other facility, a number of benefits could be derived:
These early RDE systems used "thick-client" software—software installed locally on a laptop computer's hardware—to collect the patient data. The system could then use a modem connection over an analog phone line to periodically transmit the data back to the sponsor, and to collect questions from the sponsor that the medical staff would need to answer.
Though effective, RDE brought with it several shortcomings as well. The most significant shortcoming was that hardware (e.g., a laptop computer) needed to be deployed, installed, and supported at every investigational (medical) site. In addition to being expensive for sponsors and complicated for medical staff, this model resulted in a proliferation of laptop computers at many investigational sites that participated in more than one research study simultaneously. Usability and space constraints led to a lot of dissatisfaction among medical practitioners. With the rise of the Internet in the mid 1990s, the obvious solution to some of these issues was the adoption of web-based software that could be accessed using existing computers at the investigational sites. EDC represents this new class of software.
In addition to pure software companies; pharmaceutical, biotech and contract research organizations have developed their own EDC systems (ex: e-SOCDAT, edcpro).
s (CDMS), clinical trial management systems
(CTMS), business intelligence and reporting, and others. This convergence is expected to continue until electronic patient medical records become more pervasive within the broader healthcare ecosystem—at which point the ideal solution would be to extract patient data directly from the electronic medical records as opposed to collecting the data in a separate data collection instrument. Standards such as CDISC and HL7 are already enabling this type of interoperability to be explored.
System
System is a set of interacting or interdependent components forming an integrated whole....
designed
for the collection of clinical data
Data
The term data refers to qualitative or quantitative attributes of a variable or set of variables. Data are typically the results of measurements and can be the basis of graphs, images, or observations of a set of variables. Data are often viewed as the lowest level of abstraction from which...
in electronic format for use mainly in human clinical trials.
Typically, EDC systems provide:
- a graphical user interfaceGraphical user interfaceIn computing, a graphical user interface is a type of user interface that allows users to interact with electronic devices with images rather than text commands. GUIs can be used in computers, hand-held devices such as MP3 players, portable media players or gaming devices, household appliances and...
component for data entry - a validationData validationIn computer science, data validation is the process of ensuring that a program operates on clean, correct and useful data. It uses routines, often called "validation rules" or "check routines", that check for correctness, meaningfulness, and security of data that are input to the system...
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
Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
and post-market safety surveillance
Postmarketing surveillance
Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...
, although some EDC system's such as SciAn Services edcpro are specialized to include tools for phases I-II.
EDC can increase the 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: 1) 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 2) 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.
History
EDC is often cited as having its origins in another class of software — Remote Data Entry (RDE) that surfaced in the life sciences market in the late 1980s and early 1990s. However its origins actually begin in the mid 1970s with a contract research organization known then as Institute for Biological Research and Development (IBRD). Dr. Richard Nichol and Joe Bollert contracted with Abbott Pharmaceuticals for the IBRD 'network' of Clinical Investigators to each have a computer and 'directly' enter clinical study data to the IBRD mainframe. IBRD then cleaned the data and provided reports to Abbott.Clinical research data—patient data collected during the investigation of a new drug or medical device is collected by physicians, nurses, and research study coordinators in medical settings (offices, hospitals, universities) throughout the world. Historically, this information was collected on paper forms which were then sent to the research sponsor (e.g., a pharmaceutical company) for data entry into a database and subsequent statistical analysis environment. However, this process had a number of shortcomings:
- data are copied multiple times, which produces errors
- errors that are generated are not caught until weeks later
- visibility into the medical status of patients by sponsors is delayed
To address these and other concerns, RDE systems were invented so that physicians, nurses, and study coordinators could enter the data directly at the medical setting. By moving data entry out of the sponsor site and into the clinic or other facility, a number of benefits could be derived:
- data checks could be implemented during data entry, preventing some errors altogether and immediately prompting for resolution of other errors
- data could be transmitted nightly to sponsors, thereby improving the sponsor's ability to monitor the progress and status of the research study and its patients
These early RDE systems used "thick-client" software—software installed locally on a laptop computer's hardware—to collect the patient data. The system could then use a modem connection over an analog phone line to periodically transmit the data back to the sponsor, and to collect questions from the sponsor that the medical staff would need to answer.
Though effective, RDE brought with it several shortcomings as well. The most significant shortcoming was that hardware (e.g., a laptop computer) needed to be deployed, installed, and supported at every investigational (medical) site. In addition to being expensive for sponsors and complicated for medical staff, this model resulted in a proliferation of laptop computers at many investigational sites that participated in more than one research study simultaneously. Usability and space constraints led to a lot of dissatisfaction among medical practitioners. With the rise of the Internet in the mid 1990s, the obvious solution to some of these issues was the adoption of web-based software that could be accessed using existing computers at the investigational sites. EDC represents this new class of software.
Current landscape
The EDC landscape has continued to evolve from its evolution from RDE in the late 1990s, and today the market consists of a variety of new and established software providers.In addition to pure software companies; pharmaceutical, biotech and contract research organizations have developed their own EDC systems (ex: e-SOCDAT, edcpro).
The future of EDC
As EDC software continues to mature, vendors are including capabilities that would have previously been developed and sold as separate software solutions: clinical data management systemClinical data management system
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS...
s (CDMS), clinical trial management systems
Clinical Trial Management System
A Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial...
(CTMS), business intelligence and reporting, and others. This convergence is expected to continue until electronic patient medical records become more pervasive within the broader healthcare ecosystem—at which point the ideal solution would be to extract patient data directly from the electronic medical records as opposed to collecting the data in a separate data collection instrument. Standards such as CDISC and HL7 are already enabling this type of interoperability to be explored.
See also
- Clinical data acquisitionClinical data acquisitionAcquisition 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,...
- Clinical Data Management SystemClinical data management systemA clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS...
(CDMS) - Case Report FormCase Report FormA Case Report Form is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site...
(CRF) - Remote Data EntryRemote Data EntryA Remote Data Entry 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...
(RDE) - Remote Data CaptureRemote Data CaptureRemote data capture is the process of automatic collection of scientific data. It is widely used in clinic trials, where it is referred to as electronic data capture. In physical sciences, automatic observation hardware in the field can be linked to an observer in a laboratory through a cellphone...
(RDC) - Patient-reported outcomePatient-reported outcomeA patient-reported outcome or PRO is a questionnaire used in a clinical trial or a clinical setting, where the responses are collected directly from the patient.-Overview:...
(PRO) - Title 21 CFR Part 11Title 21 CFR Part 11Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration guidelines on electronic records and electronic signatures in the United States...
- SmartPen - a technological system for digitally encoding and transmitting CRFs