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Jargon Description
Sample Size

The number of participants in the trial. The intended sample size is the number of participants planned to be included in the trial, usually determined using a statistical power calculation. The sample size should be adequate to provide a high probability of detecting as significant an effect size of a given magnitude if such an effect actually exists. The achieved sample size is the number of participants enrolled, treated or analysed in the study.

Secondary Outcome

An outcome used to evaluate additional effects of an intervention deemed as being less important than the primary outcomes.

Secondary Research

A review of individual studies (each of which is called a primary study). A systematic review is a secondary study.

Self-care and Preventative Activities

Includes any intentional actions patient takes to care for their physical, mental and emotional health.

Self-Evident Corrections

A list of corrections to the case report form that can be made by the sponsor’s data management staff without the requirement for case-by-case referral to the investigator. For example, if a case report form page lists concomitant medication taken by a patient but the box stating ‘Are there any medications this cycle?’ is blank, the box may be ticked by the data manager. A list of such data correction conventions should be agreed by the investigator prior to data management activities taking place.

Serious Adverse Event or Serious Adverse Reaction

Any adverse event or adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Serious Breach of Good Clinical Practice or Protocol

A “serious breach” is a breach which is likely to effect to a significant degree the safety or physical or mental integrity of the subjects of the trial or the scientific value of the trial.

Service Level Agreement

A communication document that makes clear what the supplier will deliver and what the organisation will ensure. It is based on the conditions of contract and specification and does not in any way replace them.

Service User

A service user is someone who uses or has used health and/or social care services because of illness or disability. Some people do not like this term because they feel it has negative connotations.

Setting

The research setting is the environment in which research is carried out. This could be a laboratory or a ‘real’ setting, such as the subject’s working environment if you are conducting research into people’s working lives.

Single Technology Appraisal

A review of evidence on one specific treatment, usually carried out for policy customers such as NICE.

Site Specific Assessment

An assessment performed to establish the suitability of a Principal Investigator and a site for the conduct of research.

Social Care Research

Social care refers to a range of services provided across different settings, usually in the community. These include, home care, day care and residential care for older people, residential care and fostering for children, support for parents of disabled children, supporting mental health service users, physically disabled people and people with learning difficulties, support for carers. Social care research involves finding out new knowledge or testing out existing ideas) to do with social care – so social care research might address questions about people’s experience of using different home care services, the best ways to train new foster parents.

Social Networking Service

A platform to build social networks among people who share interests, activities or connections. Twitter and Facebook are examples of social networking services.

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). Source data may be in hard copy or electronic format.

Source Data Verification

Checking the original data record, such as lab reports, patient medical notes against what was transferred onto the case report form/into a database.

Specialist Care

Care for people with severe health conditions in a specialist hospital. Very small number of patients needs this type of emergency or complex care.

Specificity

In screening/diagnostic tests this is a measure of a test’s ability to correctly identify people who do not have the disease.

Sponsor

The individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming that there are proper arrangements in place to initiate, manage and monitor, and finance a study. Responsibilities are defined by the Research Governance Frameworks and by the Clinical Trials Regulations.

Standard Operating Procedure

Written instructions to achieve uniformity of the performance of a specific function.

Statistic/Statistical Analysis

Statistics are a set of numbers (quantitative data) obtained through research. For example, the average age of a group of people, or the number of people using a service. Statistical analysis uses a set of mathematical rules to analyse quantitative data. It can help researchers decide what data means. For example, statistical analysis can assess whether any difference seen between two groups of people (e.g. between the groups of people in a clinical trial) is likely to be a reliable finding or simply due to chance.

Statistically Significant

A result that is unlikely to have happened by chance.

Stroke

A "brain attack". It can happen to anyone at any time. It occurs when blood flow to an area of brain is cut off. When this happens, brain cells are deprived of oxygen and begin to die. When brain cells die during a stroke, abilities controlled by that area of the brain such as memory and muscle control are lost.

Sub-Group Analysis

An analysis in which the intervention effect is evaluated in a defined subset of the participants in a trial, or in complementary subsets, such as sex or age.

Surgery

The specialty of medicine that treats diseases and disorders by cutting, removing or changing the body with an operative procedure. Surgery could either be minor or major.

Survivor Researcher

Survivor is a term some people who have used health or social care services use to describe themselves – they see this as a more empowering term than ‘patient’ or ‘sufferer’. For example, some people who have used mental health services or who have experienced mental or emotional distress call themselves survivors of the psychiatric system. Some people who have recovered from cancer call themselves cancer survivors. If someone describes themselves as a survivor researcher, they are making a statement about the fact that they have used health or social care services as well as being a researcher.

Suspected Unexpected Serious Adverse Reactions

An adverse reaction that is both unexpected (not consistent with the applicable product information) and also meets the definition of a Serious Adverse Event/Reaction.

Systematic Review

Systematic reviews aim to bring together the results of all studies addressing a particular research question that have been carried out around the world. They provide a comprehensive and unbiased summary of the research. For example, one clinical trial may not give a clear answer about the effectiveness of a treatment. This might be because the difference between the treatments being tested was very small, or because only a small number of people took part in the trial. So systematic reviews are used to bring the results of a number of similar trials together, to piece together and assess the quality of all of the evidence. Combining the results from a number of trials may give a clearer picture.