Archives: Jargon

Standard Operating Procedure: detailed written instructions designed to achieve uniformity of the performance of a specific function

Summary of Product Characteristics: smaller version of Investigator Brochure with details on pharmacological effects, side effects, but issued for a product that already holds a marketing licence

Site Management Organisation

Service Level Agreement

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

Sub-Investigator (as in ICH-GCP, ICH does not use the term Co-investigator)

Statutory Instruments: document which defines UK law in on a specific topic, e.g. how to manage a clinical 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)

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)

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

Research Support Services

Research Professorships