Our Facility
Located in sunny Kissimmee, Florida, our facillity is equipped with the latest in medical…
Primary Contact
For more information:
206 Park Place Blvd.
Kissimmee, FL 34741
Phone: 407.483.0989
Fax 407.483.0995
Glossary
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Advert drug reaction
An unintended reaction to a drug taken at normal doses.
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Adverse Event
Any negative medical event in a study subject during a study, even those not related to the treatment.
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Blinding
The process through which study subjects, the investigator and /or other involved parties in a clinical trial are kept unaware of the treatment assignments of study subjects.
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Certified Clinical Research Coordinator (CCRC)
CRC with more than two years of experience and certification earned by passing an exam.
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Clinical trial (clinical study, clinical investigation)
Any experience that involves a test article (drug, device, biologic) and one or more human subjects.
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Clinical Research Associate (CRA)
The sponsor monitor who visits sites periodically during a study to monitor the data and assess progress.
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Clinical Research Coordinator (CRC), or Study Coordinator
The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator.
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Control group
A group of subjects who are not treated with the investigational product. This group is used as a comparison to the treatment group.
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Demographic data
The characteristics of study subjects, including age, sex, medical history and other information relevant to the study.
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Double-blind
A study design in which neither the investigator nor the subject knows which treatment the subject is receiving.
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Drug
An article other than food intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.
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Efficacy
A test product’s ability to produce a beneficial effect on the duration or course of the disease.
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FDA
The United States Food and Drug Administration.
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Generic drug
A medicinal product with the same active ingredient(s) as a brand name drug. Generic products may only be marketed after the original drug’s patent has expired.
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Good Clinical Practice (GCP)
The regulations and guidelines that specify the responsibilities of sponsors, investigators, monitors and IRBs involved in clinical trials. These protect the safety, rights and welfare of the subjects in addition to ensuring the accuracy of the data collected during the trial.
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Human subject
An individual who participates in research, either as a recipient of the test article or as a control. This may be either a healthy subject or a patient.
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Inclusion or exclusion criteria
The characteristics that must be present (inclusion) or absent (exclusion) in order for a subject to qualify for a clinical trial, as per the protocol for the trial.
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Informed consent
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial.
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Inpatient trial
A study in which the subjects stay at the study site until completion of the study.
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Institutional Review Board (IRB)
Any board, committee, or group formally designated to review biomedical research involving human subjects, to approve the initiation of research and periodically review approved studies.
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Investigator (Clinical Investigator or Principal Investigator)
An individual who actually conducts a clinical investigation (under whose immediate direction the test article is dispensed) or is the responsible leader of a team.
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IRB approval
The determination of the IRB that the clinical investigation has been reviewed and may be conducted within the constraints set by the IRB and applicable regulations.
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Legally authorized representative
An individual or judicial or other body authorized under applicable law to consent to research participation on behalf of a potential subject.
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Minimal risk
The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or in the performance of routine physical or psychological examinations or tests.
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New Drug Application (NDA)
The marketing application for a new drug submitted to the FDA. The NDA contains all the nonclinical, clinical, pharmacological, pharmacokinetic and stability data required by the FDA.
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Open label study
A study in which the subjects and the investigator are aware of the drug that is being administered.
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Outpatient trial
A study in which the subjects do not stay at the study site, but travel back and forth from their residence until completion of the study.
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Park Place Behavioral Healthcare
The business park in Kissimmee, FL, where Accurate Clinical Trials is located and conducts studies. Some trials require a stay in the research center while participating in the study; in other cases, the research may be conducted through office visits.
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Placebo
An inactive substance designed to resemble the drug being tested.
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Preclinical testing
Studies conducted on animals to determine that the drug is safe to use in studies on humans.
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Principal investigator (Investigator or Clinical Investigator)
An individual who actually conducts a clinical investigation (under whose immediate direction the test article is dispensed) or is the responsible leader of a team.
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Randomization
A method in which study subjects are randomly assigned to treatment groups. It helps to reduce bias in a trial by ensuring that there is no pattern in the way subjects are assigned to treatment groups.
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Serious adverse event (SAE)
Any untoward medical occurrence at any dose that results in death, is life-threatening, requires hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
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Sponsor
The person or entity who initiates a clinical investigation, but who does not actually conduct the investigation.
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Study/trial
Used interchangeably to refer to clinical trials performed under a physician’s care to study the effect of a particular treatment on patients.
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Study coordinator (Clinical Research Coordinator)
The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator.
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Sub-investigator
Any member of an investigational team other than the investigator.
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Test article
Any drug, biologic or device being tested for use in humans.
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Unanticipated event
Problem involving risks to human subjects or others participating in a clinical research study. Can include any event from breach of confidentiality to incarceration of subject or incorrect labeling of study drug. These events are collected and reported.