|
| | |
Audit (of a clinical trial)
Audit (of a clinical trial) A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirements.
RELATED TERMS--------------------------------------
Protocol
An outline of care; a treatment plan.
Clinical
That which can be observed in patients. Research that uses patients to test new treatments, as opposed to laboratory testing or research in animals.
SIMILAR TERMS--------------------------------------
Audiogram
A test of hearing at a range of sound frequencies.
Audiologist
A health care professional who is trained to evaluate hearing loss and related disorders, including balance (vestibular) disorders and tinnitus (ringing in the ears) and to rehabilitate individuals with hearing loss and related disorders. An audiologist uses a variety of tests and procedures to assess hearing and balance function and to fit and dispense hearing aids and other assistive devices for hearing.
Audiology
The study and testing of hearing, and the provision of hearing aids.
Audiometric tests
The testing of hearing with an audiometer, whereby hearing impairments can be measured.
Audiometry
The measurement of hearing.
Audit certificate
Document that certifies that an audit has taken place at a site undertaking clinical research.
Audit trial
Documentation that allows reconstruction of the course of events.
Auditory acuity
The clarity or clearness of hearing, a measure of how well a person hears. Auditory acuity is what is measured when determining the need for a hearing aide and monitoring the ability to hear.
Auditory aphasia
Impairment in the understanding of auditory language and communication. Sounds are heard but they convey no meaning. The 20th century Russian composer Vissarion Shebalin had auditory aphasia after a stroke but remained an outstanding composer. The comprehension of auditory language and the musical organization of acoustic perception rely on different systems in the brain. Auditory aphasia is also known as acoustic aphasia and word deafness.
Auditory brainstem response test
See: ABR test.
Auditory cortex
The part of the brain that is concerned with hearing. The auditory cortex is the temporal lobe, which the lower lobe of the cerebral hemisphere just forward of the occipital lobe.
Auditory disease, central
"A condition in which there is an inability to differentiate, recognize or understand sounds while both the hearing and intelligence are normal. The problem is ""central"" as regards the auditory pathways. (In technical terms, a central auditory processing disorder is a disease of the auditory pathways from the bulbar cochlear nuclei to the auditory cortex in the temporal lobe. Structures involved in such a disorder may include the medial and lateral lemnisci, inferior colliculus, and the medial geniculate nucleus.)"
Auditory hallucination
A hallucination involving the perception of sound, most commonly of voices. Some clinicians and investigators would not include those experiences perceived as coming from inside the head and would instead limit the concept of true auditory hallucinations to those sounds whose source is perceived as being external.
Auditory integration training
An experimental procedure for reducing painful hypersensitivity to sound. It has proved beneficial for some people with autism and other neuropsychiatric disorders.
Auditory perception
The ability to identify, interpret, and attach meaning to sound.
Auditory prosthesis
A device that enhances the ability to hear or substitutes for it. More commonly called a hearing aid. See: Hearing aid.
Auditory tube
The tube that runs from the middle ear to the pharynx, also known as the Eustachian tube.
PREVIOUS AND NEXT TERMS--------------------------------------
Adverse event (AE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See also serious adverse event.
Algorithm
"Step-by-step procedure for solving a mathematical problem; also used to describe step-by-step procedures for making a series of choices among alternative decisions to reach an outcome."
Alpha error
(statistics) See Type 1 error.
Alternative hypothesis.
The opposite of a null hypothesis. See null hypothesis, research hypothesis.
Atrial fibrillation
Rapid, irregular contractions of the heart muscle fibres.
Audit (of a clinical trial)
Audit certificate
Document that certifies that an audit has taken place at a site undertaking clinical research.
Audit trial
Documentation that allows reconstruction of the course of events.
Abuse, child
Child abuse is a very complex and dangerous set of problems that include child neglect and the physical, emotional, and sexual abuse of children.
Abuse, sexual child
"Child abuse comprises four basic types of mistreatment: child neglect, physical abuse of a child, emotional abuse of a child, and sexual abuse of a child. Sexual abuse is the least frequently reported form of child abuse (6% of all cases). Experts believe that sexual abuse may be the most underreported type of child maltreatment because of the secrecy, the ""conspiracy of silence"" that so often surrounds these cases. "
We thank you for using the Health Dictionary to search for Audit (of a clinical trial). If you have a better definition for Audit (of a clinical trial) than the one presented here, please let us know by making use of the suggest a term option. This definition of Audit (of a clinical trial) may be disputed by other professionals. Our attempt is to provide easy definitions on Audit (of a clinical trial) and any other medical topic for the public at large.This dictionary contains 25007 terms. |
|
|
