Recruitment period
Time period during which subjects are or are planned to be enrolled in a clinical trial. CDISC Glossary
Time period during which subjects are or are planned to be enrolled in a clinical trial. CDISC Glossary
Federal regulations at 45 CFR 46 and 21 CFR 50 includes a list of basic elements required to be provided to the participant when seeking their Informed Consent (IC). Additional elements are also described that may be applicable to the research. Common Rule, 2018 Requirements: 45 CFR 46.116, General Requirements for Informed Consent; FDA: 21 CFR 50.25, Elements of Informed Consent
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
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 (cumulative): Current enrollment including any participants who were once enrolled and have ended participation.
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
Active efforts by the investigator and the study team to identify participants who may be suitable for enrollment into a clinical study. Participants are selected on the basis of the protocol’s inclusion criteria and exclusion criteria during the recruitment period. FDA: Clinical Trial Glossary
A written Informed Consent Form (ICF) used in short form consent stating that the elements of informed consent have been presented orally to the person providing Informed Consent (IC). Common Rule, 2018 Requirements: 45 CFR 46.117, Documentation of Informed Consent; FDA: 21 CFR 50.27, Documentation of Informed 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
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.
The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal. NIH National Institute of Aging (NIA): Glossary of Clinical Research Terms