ACORI | Dictionary: $C

Cancelled Submission

A cancelled submission is when the clinical study sponsor or investigator recalls the submission of clinical study results before quality control (QC) review is completed. A clinical study record can only be modified if it is cancelled before QC review is completed.

Cancer Care Delivery Research

Cancer care delivery research seeks to improve patient engagement with decision-making, use of evidence-based guidelines, and coordination of multi-specialty care to improve cancer care. It also includes ever-evolving electronic communication devices and technology, such as e-medicine, electronic medical records, computers, Internet, tablets, smartphones and other healthcare Internet technologies.

Carry-over Effect

Carry-over effects are any physical or emotional symptoms a participant might feel after they have stopped receiving treatment and after they have exceeded the time period during which one would normally experience symptoms from treatment.

Case History

Case history is a record maintained by the clinical study investigator that contains all medical and health information regarding each participant in a clinical study.

Case Reporting Form

A case reporting form is a document (printed, electronic, etc.) that contains all protocol-required information for a clinical study. (NIH)

Cell Therapy

Cell therapy treats or prevents diseases using human cells that were grown, treated, or altered outside of the body. These cells are taken from the patients (autologous cells) or a donor (allogeneic cells). It is also when clinicians modify the function of cells inside the body to treat diseases or conditions.

Certificate of Confidentiality

Certificates of confidentiality protect the privacy of research participants by prohibiting the disclosure of identifiable, sensitive research information to anyone not connected to the research except when the participant consents or in a few other specific situations. (NIH)

Certification

A sponsor or investigator may submit a certification to delay submitting the results of a clinical study if they are applying for Food and medicine Administration approval of a new medicine or device, or new use of an already approved medicine or device.

Clinical Benefit

A therapeutic intervention may be said to provide clinical benefit or a favorable effect if it improves how a participant feels (i.e., symptom relief), how a participant functions (i.e., improved mobility), or if prolongs a participant's life (survival).

Clinical Data

Clinical data is information pertaining to the medical well-being or status of a clinical study participant.

Clinical Efficacy

Clinical efficacy is the quantitative power or capacity of a treatment to produce a desired therapeutic effect.

Clinical Encounter

A clinical encounter is contact between a participant and a healthcare practitioner/researcher during which an assessment or activity is performed (i.e., physical exam).

Clinical Investigation

Clinical investigation is synonymous with clinical study and refers to any study involving human volunteers (also called participants) that is intended to add to medical knowledge. It is conducted under established guidelines by trained medical professionals. There are two main types of clinical studies, clinical trials and observational studies. A clinical trial tests or evaluates an intervention — medicine, medical device, activity, or procedure — in people. In an observational study, researchers observe participants on their current treatment plan and track health outcomes.

Clinical Research

Clinical research is synonymous with clinical study and refers to any study involving human volunteers (also called participants) that is intended to add to medical knowledge. It is conducted under established guidelines by trained medical professionals. There are two main types of clinical studies, clinical trials and observational studies. A clinical trial tests or evaluates an intervention — medicine, medical device, activity, or procedure — in people. In an observational study, researchers observe participants on their current treatment plan and track health outcomes.

Clinical Research Coordinator

A clinical research coordinator is an individual that handles the administrative and day-to-day responsibilities of a clinical study. This person acts as the liaison between various members of the clinical study team and may collect the data or review it before it is entered into a study database.

Clinical Research Subject

A clinical research subject is a participant who is enrolled in a clinical study. (CDISC)

Clinical Significance

Clinical significance refers to any change in a clinical study participant's health status that is regarded as important or that has a real, noticeable effect on the participant's daily life, whether or not it is related to the treatment being tested in the clinical study (i.e., reduction of symptoms or treatment effects). The criterion or criteria for clinical significance should be clearly stated in the clinical study protocol.

Clinical Study

A clinical study is structured medical research involving human volunteers that is intended to add to medical knowledge. It is conducted under established guidelines by trained medical professionals. There are two main types of clinical studies, clinical trials and observational studies. A clinical trial tests or evaluates an intervention — medicine, medical device, activity, or procedure — in people. In an observational study, researchers observe participants on their current treatment plan and track health outcomes.

Clinical Study Coordinator

A clinical study coordinator is an individual that handles the administrative and day-to-day responsibilities of a clinical study. This person acts as the liaison between various members of the clinical study team and may collect the data or review it before it is entered into a study database.

Clinical Trial

The term clinical trial is synonymous with interventional clinical trial and they are both subsets of the term clinical study. A clinical trial (or interventional clinical trial) tests or evaluates an intervention — medicine, medical device, activity, or procedure — in people. The other main type of clinical study is an observational study. In an observational study, researchers observe participants on their current treatment plan and track health outcomes.

Clinical Trials Support Unit

The Clinical Trials Support Unit is a project sponsored by the National Cancer Institute (NCI) that supports a national network of investigators and clinical and research staff to participate in NCI-sponsored cancer treatment studies.

ClinicalTrials.gov Identifier

"A ClinicalTrials.gov identifier is the unique identification code that ClinicalTrials.gov (the official website to register clinical studies) provides when they register a clinical study. The format is ""NCT"""" followed by an 8-digit number (for example"

Cognitive Debriefing

Cognitive debriefings are follow-up questions that help clinical study investigators better understand how well participants understand questions asked of them (i.e., survey questionnaire) and determine whether concepts and items in the questions are understood by participants in the same way as intended by the clinical study's design.

Cohort

A cohort is a group of individuals who share a common exposure, experience, or characteristic based on criteria established by the clinical study investigator.

Cohort Studies

Cohort studies compare a particular outcome (i.e., lung cancer or diabetes) in groups of individuals who are alike in many ways (i.e., age, gender) but differ by a certain characteristic, and follow them over time. For example, female nurses who smoke compared with female nurses who do not smoke to assess lung cancer risk. Cohort studies can be prospective (participants are followed forward in time) or retrospective (researchers look at participants' past medical and lifestyle history).

Collaborator

A collaborator is an organization or individual (other than the sponsor) that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. (CTG)

Combination Product

A combination product is composed of any combination of two or more different types of medical products (e.g., medicine, device, and/or biological product).

Common Terminology Criteria for Adverse Events (CTCAE)

The National Cancer Institute created common terminology criteria for adverse events to standardize the classification of adverse effects associated with medicines used in cancer therapy. The criteria utilizes a range of grades from 1 to 5 to rate the severity of adverse events. Specific conditions and symptoms may have values or descriptive comments for each level, but the general guideline is: 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death

Community Clinical Oncology Program

The Community Clinical Oncology Program was a network that connected community physicians with organization that design and conduct clinical studies (e.g., academic medical centers and cooperative groups). It has been replaced by NCI Community Oncology Research Program and the Association of Community Cancer Centers.

Comparative Study

In comparative studies, a treatment or intervention is compared against another treatment, intervention, or no treatment.

Compassionate Use

Compassionate use allows for patients with serious diseases or conditions who cannot participate in a clinical study to gain access to a medical product that has not been approved by the Food and Drug Administration.

Compliance

Compliance refers to a clinical study's adherence to the requirements set out in the clinical study design and all applicable regulatory requirements.

Concomitant Medication

Concomitant medication are prescription and over-the-counter medications and dietary supplements that a clinical study participant takes in addition to the medication provided in the clinical study. Some studies may record only those concomitant medications that may interact with the clinical study or intervention or that may exclude an individual from participating in a clinical study.

Condition

A condition is the disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Confirmation Trial

A confirmation trial is a phase 3 trial. It is intended to confirm the preliminary evidence accumulated in earlier studies and prove the treatment safe so that it can be approved by the FDA for sale and general use by the public.

Conflict of Interest (COI)

Conflict of interest is when individuals involved with any aspect of a clinical study (e.g., design, conduct, reporting, oversight, or review of research) also have financial or other interests, from which they can benefit, depending on the results of the research. Regarding research, conflict of interest is taken very seriously and they are regulated and must be reported, ensuring research integrity and ethical standards.

Consent Form

A consent form is a document used during the preliminary stages of signing up for a clinical study that explains to potential participants the purpose and procedures involved, the risks and potential benefits, and the rights and responsibilities of the parties involved. If participants decide to enter the study, they must sign the document to give official consent.

Contact

Contact is any activity, anticipated in the clinical study protocol, involving a subject and pertaining to the collection of information for a clinical study. (CDISC)

Contact

Contact refers to the contact information of the person who can answer information and enrollment questions for a clinical study.

Control

"Control refers to the treatment that researchers use as a basis to compare the value, effect, and impact of the treatment the clinical study is testing or evaluating. A control might be the current, commonly-used Food and Drug Administration approved ""standard of care"""" treatment or no treatment."""

Control Arm

"A control arm is the group of participants in a clinical study who are assigned to the control treatment, which is the treatment that researchers use as a basis to compare the value, effect, and impact of the treatment the clinical study is testing or evaluating. A control group might be receiving the current, commonly-used Food and Drug Administration approved ""standard of care"""" treatment or no treatment."""

Control Group

"A control group is the group of participants in a clinical study who are assigned to the control treatment, which is the treatment that researchers use as a basis to compare the value, effect, and impact of the treatment the clinical study is testing or evaluating. A control group might be receiving the current, commonly-used Food and Drug Administration approved ""standard of care"""" treatment or no treatment."""

Controlled Access

Controlled access means that one must get permission from the National Institutes of Health in order to see and/or use information gathered from a clinical study.

Controlled Clinical Study

"A controlled clinical study is a type of study where at least one group of participants receives the treatment being tested and at least one group receives the control treatment, which is a treatment that researchers use as a basis to compare the value, effect, and impact of the treatment being tested or evaluated. A control might be the current, commonly-used Food and Drug Administration approved ""standard of care"""" treatment or no treatment."""

Cooperative Group

A cooperative group is a group of researchers, cancer centers, and community doctors who are involved in studies of new cancer treatments, preventative treatments, advances in early detection, and ways to improve quality of life and post-cancer rehabilitation. Clinical studies carried out by cooperative groups are sponsored by the National Cancer Institute, and large numbers of participants take part in many locations. An example of a cooperative group is the SWOG Cancer Research Network.

Coordinating Center (CC)

A coordination center (CC) is a large group organized to coordinate the planning and operational aspects of a multi-center clinical study. CCs may also be referred to as data coordinating centers or data management centers. (NIH)

Correlation

Correlation is the manner in which two or more data variables (elements, features, or factors) are related or associated. For example one might see a correlation between the age or participants in a clinical study and the rate of heart disease. This indicates a relationship in the participants. However, it does not specify whether or not one causes the other.

Covariate

A covariate is a factor or condition that, even though is not the main interest of the clinical study, is associated with the outcome and may influence the outcome of a clinical study (i.e., treatment success), either because it has a direct or indirect effect on the outcome. Some covariate examples may include, weight, comorbidities, smoking, etc.

Cross-labeled Product

Cross-labeled products are investigational medicines, devices, or biological products that are packaged separately but intended to be used together to get the intended effect.

Cross-over Assignment

Cross-over assignment is when each group of participants in a clinical study receive the same medicines but in a different order. For example one group might receive medicine A first and then medicine B and the second group will receive medicine B first and then medicine A. Cross over is often initiated by time or the efficacy of the first treatment.

Cross-over Trial

A cross-over trial is a clinical study in which each group of participants receive the same medicines but in a different order. For example one group might receive medicine A first and then medicine B and the second group will receive medicine B first and then medicine A. Cross over is often initiated by time or the efficacy of the first treatment.

Cross-sectional Study

A cross-sectional study is a clinical study that measures the health status of a population at a point in time or over a short period of time. It usually targets certain health outcomes or determinants of health, like the rate of cancer or diabetes in persons over 40 living in New York City.

Clinical Research Terms Glossary

Terms starting with C

Cancelled Submission

Cancer Care Delivery Research

Carry-over Effect

Case History

Case Reporting Form

Cell Therapy

Certificate of Confidentiality

Certification

Clinical Benefit

Clinical Data

Clinical Efficacy

Clinical Encounter

Clinical Investigation

Clinical Research

Clinical Research Coordinator

Clinical Research Subject

Clinical Significance

Clinical Study

Clinical Study Coordinator

Clinical Trial

Clinical Trials Support Unit

ClinicalTrials.gov Identifier

Cognitive Debriefing

Cohort

Cohort Studies

Collaborator

Combination Product

Common Terminology Criteria for Adverse Events (CTCAE)

Community Clinical Oncology Program

Comparative Study

Compassionate Use

Compliance

Concomitant Medication

Condition

Confirmation Trial

Conflict of Interest (COI)

Consent Form

Contact

Contact

Control

Control Arm

Control Group

Controlled Access

Controlled Clinical Study

Cooperative Group

Coordinating Center (CC)

Correlation

Covariate

Cross-labeled Product

Cross-over Assignment

Cross-over Trial

Cross-sectional Study