Skip to main content

Tooltip Categories: Informed Consent

Health literacy

The degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make health decisions. CDISC Glossary

Enrollment

The action of enrolling one or more participants. The participant will have met the eligibility criteria to participate in the study and will have signed an informed consent form (ICF). CDISC Glossary

Enrollment (current): Participants actively continuing to participate in a clinical trial as of the current date.

Enrollment (cumulative): Current enrollment including any participants who were once enrolled and have ended participation.

Enrolled

Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting eligibility criteria as specified in the protocol. CDISC Glossary

Short form consent

An alternative method of documenting Informed Consent (IC) in which the elements of informed consent are presented orally to the participant, the participant’s Legally Authorized Representative (LAR), parent or guardian in conjunction with a short form. An impartial witness must be present to attest to oral presentation. Also, the Institutional Review Board (IRB) must approve a written summary of what is to be said to the person providing informed consent (the Informed Consent Form (ICF) that embodies all the required elements of informed consent, also known as the long form, may serve as the summary). Only the short form itself is to be signed by the person providing consent. The person obtaining consent must sign a copy of the summary. The witness shall sign both the short form and a copy of the summary. A copy of the summary is provided to the person providing consent in addition to a copy of the short form. Common Rule, 2018 Requirements: 45 CFR 46.117, Documentation of Informed Consent; FDA: 21 CFR Part 50.27, Documentation of Informed Consent

Short form consent may be used with persons with limited English proficiency. If short form consent is used for the purpose of consenting a participant with limited English proficiency, an interpreter, who is fluent in both English and the preferred language of the person providing consent is required. The interpreter may also serve as the witness. UNC-Chapel Hill OHRE SOP 1101

Recruitment status

The state of participant recruitment for a study:

Not yet recruiting: The study has not started recruiting participants.

Recruiting: The study is currently recruiting participants.

Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that population, who are specifically invited to participate.

Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Suspended: The study has stopped early but may start again.

Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.

Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the final participant’s last visit has occurred).

Withdrawn: The study stopped early, before enrolling its first participant.

NIH ClinicalTrials.gov: Glossary of Common Site Terms