28 May 2019

By Jerome Zakka

Decoding the Alphabet Soup: A Guide to eClinical Systems Acronyms

This is an excerpt from our free downloadable resource ‘The Clinical Trial Acronym Handbook’. To get your full copy of the handbook, click here.

The life sciences industry, like many others, uses a proliferating alphabet soup of acronyms to communicate about processes and technology. At this point there are so many that even industry insiders have a difficult time keeping up with the growing number of acronyms needed to be memorized and understood. Within the industry, the clinical trials world and particularly eClinical systems have their own set of acronyms. While this is not an exhaustive list, we identify the most commonly used eClinical system acronyms: what they are, what they represent, and what they mean.

  • ADaM: analysis data model (a CDISC standard)
    Defines dataset and metadata standards that support: (1) efficient generation, replication, and review of clinical trial statistical analyses, and (2) traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).
  • API: application programming interface
    A set of programming instructions and standards for accessing a Web-based software application or Web tool. A software company releases its API to the public so that other software developers can design products powered by its service.
  • CDASH: Clinical Data Acquisition Standards Harmonization (a 2006 CDISC initiative)
    A standard way to collect data across studies and sponsors so that collection formats and structures provide clear traceability of submissions into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.
  • CDISC: Clinical Data Interchange Standards Consortium
    An organization that develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a powerful framework for generating clinical research data. (Link to our blog post about CDISC.)
  • CFR: Code of Federal Regulations
    A codification (arrangement of) the general and permanent rules published in the US Federal Register by the executive departments and agencies of the federal government. For eClinical systems, the most pertinent CFR section is 21 CFR 11.
  • CTMS: clinical trial management system
    Defines and manages all the activities that span the lengthy and rigorous clinical trial process.
  • DDE: double data entry
    Performed when data is entered by two operators separately. The second pass entry (entry made by the second person) helps in verification and reconciliation by identifying the transcription errors and discrepancies caused by illegible data. DDE is used with paper-based case report forms.
  • DICOM: Digital Imaging and Communications in Medicine
    The international standard for transmitting, storing, retrieving, printing, processing, and displaying medical imaging information.
  • eCRF: electronic case report form
    An electronic version of a case report form – an auditable electronic record of information generally reported to the sponsor on each trial subject, according to a clinical investigation protocol. The eCRF enables clinical investigation data to be systematically captured, reviewed, managed, stored, analyzed, and reported.
  • EDC: electronic data capture
    The computerized collection and management of clinical trial data from patients and subjects. An EDC system uses technology to streamline the collection and transmission of clinical trial data from the patient.
  • EHR: electronic health record
    A digital version of a patient’s paper chart. EHRs are real-time, patient-centered records that make information available instantly and securely to authorized users.
  • ePRO: electronic patient-reported outcomes (includes WebPRO – web-based patient-reported outcomes)
    Tools that use dedicated hand-held devices, mobile (phone/tablet) technology, or web portals to capture the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.
  • ETL: extraction – transformation – loading
    A type of data integration that refers to the three steps (extract, transform, load) used to blend data from multiple sources. During this process, data is taken (extracted) from a source system, converted (transformed) into a format that can be analyzed, and stored (loaded) into a data warehouse or other system.
  • eTMF: electronic trial master file
    An electronic collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated – basically the story of how the trial was conducted and managed.
  • IWRS: interactive web response system
    Allows sponsors to proactively manage the key aspects of their clinical trials, including enrollment/randomization, dosing/drug dispensation, clinical supplies, drug inventory management, unblinding, etc.
  • MDR: metadata repository
    A database of data about data (metadata). The purpose of the metadata repository is to provide a consistent and reliable means of access to data.
  • ODM-XML: operational data model – an extended markup language
    A vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information.
  • SaaS: software as a service
    A method of software delivery that allows data to be accessed from any device with an Internet connection and web browser. In this web-based model, software vendors host and maintain the servers, databases, and code that constitute an application.
  • SaS: statistical analysis system
    A software suite developed by SAS Institute for advanced analytics, multivariate analysis, business intelligence, data management, and predictive analytics.
  • SDTM: Study Data Tabulation Model
    A standard for organizing and formatting data to streamline processes in the collection, management, analysis, and reporting. It is the format required for submission of clinical data to the US FDA and Japan’s PMDA (Pharmaceuticals and Medical Devices Agency).
  • UAT: user acceptance testing
    The last phase of the software testing process when actual software users test the software to make sure it can handle required tasks in real-world scenarios, according to specifications.

While there are many more acronyms to decode, this list will aid your understanding and ease your journey as you navigate through the most commonly used eClinical system terms.

For our list of general clinical acronyms, please visit the first part of our acronym decoding series: Decoding the Alphabet Soup: A Guide to Clinical Research Acronyms.

Image Credit: Color4260/

Hello, I'm Jerome Zakka

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