Page 50 - Terminology-Clinical-Research

Record: An entry on ClinicalTrials.gov that contains on in advance by the researchers. These studies are not
summary protocol information about a clinical study, open to everyone who meets the Eligibility Criteria but
such as Recruitment status; Eligibility criteria; contact only to people in that particular population, who are
information; and, in some cases, summary results. Each specifically invited to participate.
study record is assigned a ClinicalTrials.gov Identifier
(NCT Number). Temporarily not available for expanded access: An
Expanded access program is not currently available for this
Recruitment (investigators): Process used by sponsors to intervention but is expected to be available in the future.
identify, select, and arrange for investigators to serve in a
clinical study. No longer available for expanded access: An Expanded
Access program was available for this intervention
Recruitment (subjects): Process used by investigators to previously but is not currently available and will not be
find and enroll appropriate subjects (those selected on the available in the future.
basis of the protocol’s inclusion and exclusion criteria) into
a clinical study. Approved for marketing: Applies to an Expanded Access
program. The intervention has been approved by the Food
Recruitment period: Time period during which subjects and Drug Administration for use by the public.
are or are planned to be enrolled in a clinical trial.
Open or closed studies
Recruitment status: Indicates the current stage of
a clinical study and whether it is or will be open for Unknown: A study in ClinicalTrials.gov with a status of
enrollment. The possible recruitment statuses are: Recruiting; Not yet recruiting; or Active, not recruiting
and whose status has not been verified within the past 2
Open studies years. Studies with an Unknown status are considered open
studies or closed studies, depending on their last known
Recruiting: The study is currently recruiting participants. Recruitment Status.

Not yet recruiting: The study has not started recruiting Recruitment target: Number of subjects that must be
participants. recruited as candidates for enrollment into a study to meet
the requirements of the protocol. In multicenter studies,
Available for expanded access: An Expanded Access each investigator has a recruitment target.
program is currently available for this study intervention.
Reference Information Model: An information model
Closed studies
used as the ultimate defining reference for all HL7
Active, not recruiting: The study is ongoing (that standards.
is, participants are receiving an intervention or being Registration: The process of submitting and updating
examined), but potential participants are not currently being summary information about a clinical study protocol, from
recruited or enrolled.
its beginning to end, to a structured, Web-based registry
Completed: The study has ended normally, and that is accessible to the public.
participants are no longer being examined or treated (that Registration of controlled and uncontrolled trials:
is, the “last subject, last visit” has occurred).
Registry: A data bank of information on clinical trials
Terminated: The study has stopped recruiting or enrolling for drugs for serious or life-threatening diseases and
participants early and will not start again. Participants are
no longer being examined or treated. conditions. Note: The registry should contain basic
information about each trial sufficient to inform interested
Suspended: The study has stopped recruiting or enrolling subjects (and their healthcare practitioners) how to enroll in
participants early but may start again. the trial.

Withdrawn: The study stopped early, before enrolling its Regulatory authorities: Bodies having the power to
first participant. regulate. Regulatory authorities review and evaluate
clinical study data and are responsible for ensuring new
Enrolling by invitation: A study that selects its medications are safe and effective for their intended
participants from a population, or group of people, decided use before they are approved for use by patients. If a

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