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Sponsor
Sponsor An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial
RELATED TERMS--------------------------------------
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--------------------------------------
Spondarthritis
Spondylarthopathy. A seronegative arthropathy related to ankylosing spondylitis and often also to the possession of HLA B27.
Spondylarthritis
Defect in pars interarticularis of vertebra.
Spondylitis
Inflammation of the vertebrae.
Spondylolisthesis
Malalignment of vertebrae due to spondylolysis or degenerative change which allows one vertebra to slip forward on top of another.
Spondylosis
A degenerative process of the cervical spine that causes narrowing of the spinal canal and neural foramina, and produces compression of the spinal cord and nerve roots.
Spontaneous abortion
A miscarriage, that is, any pregnancy that is not viable (the fetus cannot survive) or in which the fetus is born before the 20th week of pregnancy. Spontaneous abortion occurs in at least 15-20% of all recognized pregnancies and usually takes place before the 13th week of pregnancy. A spontaneous abortion is as opposed to an induced abortion. In a spontaneous abortion, it is purely accidental, that is spontaneous.
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Safety and tolerability
The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology), vital signs, clinical adverse events (diseases, signs and symptoms), and other special safety, tests (for example, ECGs opthamology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject
Serious adverse drug reaction (SADR)
A serious adverse event (SAE) which is possibly an adverse drug reaction (ADR)
Serious adverse event (SAE)
Any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. See adverse event (AE)
Single-blind study
One in which subjects do not know whether they are receiving the active drug or a placebo, but the investigator does know
Source data
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies)
Sponsor
Standard deviation (statistics)
Indicator of the relative variability of a variable around its mean; the square root of the variance
Standard operating procedures (S0Ps)
Detailed, written instructions to achieve uniformity of the performance of a specific function
Statistical analysis plan
A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary, variables and other data.
Statistical significance
Level at which an investigator can conclude that observed differences are not due to chance alone; for example, a p value of .05 (also called significance at the .05 level) indicates that there is about 1 chance in 20 that the differences observed occurred by chance alone.
Stochastic (statistics)
Involving a random variable; involving chance or probability.
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