This jargon buster or glossary of words contains the definitions of some of the terms commonly used in public involvement in research. It is not a complete list of all the words you might come across. The original definitions were developed for INVOLVE by TwoCan Associates working in consultation with a panel of researchers and a panel of people who use services, and we add to them continually.
The jargon buster can be searched by clicking on one of the letters below or browsing all terms.
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.
We are science-added because we ask if the proposal meets the scientific quality we insist on, and how we can support the delivery and improvement of quality. We actively apply scientific knowledge, expertise and methods to support the scientific quality of proposals and funded research. We communicate closely with the research community, and provide significant post award support and monitoring.
Source Data Verification: checking the original data record, such as lab reports, patient medical notes against what was transferred onto the CRF/into a database
An outcome used to evaluate additional effects of an intervention deemed as being less important than the primary outcomes.
A review of individual studies (each of which is called a primary study). A systematic review is a secondary study.
Nobody on Facebook can see a secret group other than those in the group. This group will not appear anywhere on a person’s profile, and only those within the group can see who the members are and what is posted. For more information see http://facebook.about.com/od/PagesGroups/ss/Everything-You-Need-To-KnowAbout-Facebook-Groups.htm
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 medications 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.
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.
Comment: Medical judgement should be exercised in deciding whether an adverse event/reaction should be classified as serious in other situations. Important adverse events/reactions that are not immediately life-threatening or do not result in death or hospitalisation, but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definition above, should also be considered serious.
* Life-threatening in the definition of a serious adverse event or serious adverse reaction refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe.
A “serious breach” is a breach which is likely to effect to a significant degree:
a) the safety or physical or mental integrity of the subjects of the trial; or
b) the scientific value of the trial.
Adverse drug reaction which falls in to one of the serious criteria and therefore warrants expedited reporting (serious = resulting in hospitalisation, prolonged hospitalisation, death, life-threatening, congenital anomaly/birth defect or persistent or significant disability/incapacity)
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.
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.
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.
Statutory Instruments: document which defines UK law in on a specific topic, e.g. how to manage a clinical trial
Sub-Investigator (as in ICH-GCP, ICH does not use the term Co-investigator)
A review of evidence on one specific treatment, usually carried out for policy customers such as NICE.
The NHS organisation in which study activities and assessment are performed or the location(s) where trial-related activities are actually conducted. Each site/Trust needs to give R&D approval
A messaging service which enables users to communicate with people by voice, video and instant messaging over the internet.
Service Level Agreement