Learn more about clinical research by visiting the following resources:
- Arm: a group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
- Clinical study: a research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and
- Clinical trial: another name for an interventional study.
- ClinicalTrials.gov identifier (NCT number): the unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
- Eligibility criteria: the key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a
person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.
- Informed consent: a process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study.
- Intervention/treatment: a process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions
can also include noninvasive approaches, such as education or modifying diet and exercise.
- Observational study: a type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of
interventions, but the investigator does not assign participants to a specific interventions/treatment.
- Placebo: an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
- Principal Investigator (PI): the person who is responsible for the scientific and technical direction of the entire clinical study.
- Protocol: the written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
- Research Services Professional (RSP): the title of clinical research coordinators at the University of Colorado. The RSP coordinates research visits and helps the PI carefully manage the participant’s
- Sponsor: the organization or person who initiates the study and who has authority and control over the study.
- U.S. Food and Drug Administration (FDA): an agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other
biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.
*all above definitions were copied from the Clinicaltrials.gov Glossary of Common Site Terms
is critical in helping to advance our knowledge of neurological
diseases in order to best care for our patients. We also welcome Healthy Volunteers to participate in our studies!
Join us and become a part of the Neurology Clinical Research family as we aim to become a Center of Research Excellence!
For questions about our clinical research, please contact the Neurology Research Recruitment Team at 303-724-4644 or NeuroResearch@CUAnschutz.edu