Page 21 - Terminology-Clinical-Research

population) for which it is designed. equivalent of the individual’s handwritten signature.

Efficacy trial: A trial designed to determine if a treatment Element: 1. In trial design, a basic building block for
is able to treat or prevent a given medical condition. time within a clinical trial comprising the following
characteristics: a description of what happens to the subject
EH & S: Environmental Health and Safety. during the element; a definition of the start of the element; a
rule for ending the element. 2. A section of text in an XML
Elderly: Subjects are aged 65 years or more.
document delimited by start and end tags; or, in the case of
Electronic approval of applications: The electronic empty elements (elements with no content, only attributes)
approval of applications by the institution for which indicated by an empty tag.
the Nominated Principal Applicant has identified as the Eligibility criteria: The key standards that people who
Institution Paid.
want to participate in a clinical study must meet or the
Electronic data capture (EDC): The process of collecting characteristics they must have. Eligibility Criteria include
clinical trial data into a permanent electronic form. Note: both inclusion criteria and exclusion criteria. For example,
Permanent in the context of these definitions implies that a study might only accept participants who are above or
any changes made to the electronic data are recorded below certain ages.
with an audit trail. EDC usually denotes manual entry of
CRF data by transcription from source documents. The EMA: European Medicines Agency. (See European
Medicines Agency).
transcription is typically done by personnel at investigative
sites. EMA Decision number of PIP: European Medicines
Agency’s decision number for the Paediatric Investigation
Electronic health record (EHR): An electronic record Plan (PIP).
for healthcare providers to create, import, store, and use
clinical information for patient care, according to nationally Emergency situation: Situation where urgent care is
recognized interoperability standards. Note: The EHR has needed for the patient and this involves enrolment in the
the following distinguishing features: able to be obtained trial (for example: head injury).
from multiple sources; shareable; interoperable; accessible
to authorized parties. Empirical: Based on observation or experience, not
experimental data.
Electronic medical record (EMR): An electronic
record for healthcare providers within one healthcare End of a trial: The last follow-up of the last recruited trial
organization to create, store, and use clinical information participant for the primary outcome as defined in the initial
for patient care. An electronic record derived from a protocol.
computerized system used primarily for delivering patient
care in a clinical setting. Note: EMRs may serve as source Endpoint: Overall outcome that the protocol is designed
documents, and such data could serve also as source data to evaluate. Common endpoints are severe toxicity,
for clinical trials provided that the controls on the EMR disease progression, or death. Note: Not all endpoints are
system and the transfer of such data to the eClinical trial themselves assessments since certain endpoints might
system were to fulfill regulatory requirements (e.g., 21 CFR apply to populations or emerge from analysis of results.
11). That is, endpoints might be facts about assessments (e.g.,
prolongation of survival).
Electronic personal health record (ePHR): An electronic
record for individuals to create, import, store, and use Enroll: To register or enter a subject into a clinical trial.
clinical information to support their own health. Note: Once a subject has been enrolled, the clinical trial
protocol applies to that subject.
Electronic record: Any combination of text, graphics,
data, audio, pictorial, or other information representation in Enrolling by invitation: A clinical study that selects its
digital form that is created, modified, maintained, archived, participants from a population, or group of people, decided
retrieved, or distributed by a computer system. on in advance by the researchers. These studies are not
open to everyone who meets the eligibility criteria but only
Electronic signature: A computer data compilation of to people in that particular population, who are specifically
any symbol or series of symbols, executed, adopted, or invited to participate. A type of recruitment status.
authorized by an individual to be the legally binding

TERMINOLOGY CLINICAL RESEARCH 21