Electronic data capture
Electronic Data Capture (EDC) refers to a category of software supporting research data management, specifically as used by a centralized data coordinating center in multi-site clinical trials and disease registries. Core EDC functionality includes web-based data entry forms, quality checking of entered data, and a limited set of other functionality supporting research operations. While commonly referred to as EDC the workflow is not truly capturing electronic data, it is a tool enabling staff at research sites to do direct data entry into a centralized database. Software in this same category are described as Remote Data Entry (RDE), Remote Data Capture (RDC) and Direct Data Entry (DDE).
The typical scenarios supported by EDC systems include:
- development and launch of a website to collect data on project-specific electronic case report forms (eCRF’s) with ability to check data against a pre-defined set of conformance criteria
- clinical site study coordinators to login to the system and perform data entry and data review activities
- coordinating center staff to review and track status of data forms, plus ancillary tasks such as medical coding and loading of laboratory data
- 4) extraction of data from the EDC system into SAS  or similar software for statistical analysis.
There are a variety of related data systems in this class targeting clinical research bound by common regulatory constraints such as the Code of Federal Regulations, Section 21, Part 11  (21CFR11 or ‘Part 11’) and market segment representing the pharmaceutical, device and large NIH research programs. This landscape includes, but is not limited to, randomization systems (often labeled Interactive Voice or Web Response Systems – IVRS/IWRS), clinical trial management systems (CTMS) and electronic patient reported outcomes (ePRO) systems. Other related data systems are not unique to research, such as laboratory and imaging systems, however only some specific software of those types includes functionality geared toward research users.
The workflow and systems designed to support research are typically technically and operationally isolated from the clinical environment; however, significant work is happening to integrate the two worlds. The most significant efforts are being driven by the Clinical Data Interchange Standards Consortium (CDISC) , an organization similar in objectives and methodology to, and collaborator with, Health Level Seven (HL7) . Two highlights of CDISC’s efforts to bring the clinical and research enterprises closer includes developing an electronic health record profile which could be certified by the government to encourage consistent compliance with research requirements  and a project with Integrating the Healthcare Enterprise  (IHE) to provide guidance on the implementation of an integrated clinical research workflow in the patient care setting. 
- CDISC Healthcare Link Initiative: Clinical Data Interchange Standards Consortium, Inc. http://www.cdisc.org/health/index.html
- “CDISC Clinical Research Glossary”, Applied Clinical Trials Online, December 1, 2008, http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/CDISC-Clinical-Research-Glossary/ArticleStandard/Article/detail/571305/
- “SAS 9.2 Software”, SAS Institute, http://www.sas.com/software/sas9/
- “Title 21 Code of Federal Regulations (21 CFR Part 11), Electronic Records; Electronic Signatures”, U.S. Food and Drug Administration, March 2000, http://www.fda.gov/ora/compliance_ref/Part11/
- Clinical Data Interchange Standards Consortium (CDISC), http://www.cdisc.org/
- Health Level Seven (HL7), http://www.hl7.org
- “ANSI Seeks Funding to Ensure that Electronic Health Records Will Support Clinical Research Activities, Twenty-seven leading organizations from the clinical research community have already pledged support”, American National Standards Institute, New York, February 13, 2009, http://www.ansi.org/news_publications/news_story.aspx?menuid=7&articleid=2107
- Integrating the Healthcare Enterprise, http://www.ihe.net