Archives: Jargon
Suspected Unexpected Serious Adverse Reactions (SUSAR)
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. View a flowchart (pdf, 180.98 KB) outlining the assessments required to determine whether a SUSAR has occurred.
Summary of Product Characteristics (SmPC or SPC)
The basis of information for health professionals on how to use the medicinal product safely and effectively. They are written and updated by pharmaceutical companies and are based on their research and product knowledge. It is then checked and approved by the UK or European medicines licensing agency. The leaflet that is included in the pack with …
Substantial Amendment
A change to the terms of the approval given by either: the competent authority (MHRA in the UK) or the research ethics committee or; a change to the protocol or any other document submitted with the applications, which significantly affects one of the following: the safety or physical or mental integrity of study participants the …
Subject
An individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control. The preferred term for the HRA, NRES and many key trials stakeholders is ‘Participant’ but the term ‘Subject’ is referenced in law for CTIMPs. See also Participant.
Statistical Analysis Plan
A statistical analysis plan is 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.
Standard Operating Procedure (SOPs)
Written instructions to achieve uniformity of the performance of a specific function.
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. For CTIMPs, the sponsor (or their legal representative) must …
Source Documents
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at …
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. See Reflection …
