Audit trial
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  Audit trial



Audit trial

   Documentation that allows reconstruction of the course of events.

RELATED TERMS
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Documentation
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a trial and the actions taken.



SIMILAR TERMS
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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 (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.

Audit certificate
Document that certifies that an audit has taken place at a site undertaking clinical research.

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
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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)
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.

Audit certificate
Document that certifies that an audit has taken place at a site undertaking clinical research.

Audit trial

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. "

Abuse, steroid
Use of substances containing anabolic steroids to increase muscle mass. Such steroids can have many side effects when misused, including psychiatric problems, liver tumors, reduction in the size of the male genitals and sterility, and heart damage.

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