The degree to which a medicine is poisonous. How much of a medicine can be taken before it has a toxic effect.

Activities carried out to identify suitable topics for research. These activities provide a way for individuals and groups to propose areas where good evidence is lacking or unanswered questions exist.

A call for proposals in a particular area of medicine or health (e.g. obesity, dementia).

A systematic assessment of an intervention (or group of interventions), usually undertaken for policy customers such as NICE.

School for Social Care Research

Systematic Reviews Programme

School for Public Health Research

School for Primary Care Research

A substantial amendment can be defined as an amendment to the protocol or any other study specific documentation, the terms of the REC application or the terms of the CTA application (as applicable) that is likely to affect to a significant degree the:

• The safety or physical or mental integrity of the subjects of the trial;
•  The scientific value of the trial; The conduct or management of the trial; or
•  The quality or safety of any investigational medicinal product used in the trial.

Other changes to the particulars of a study that qualify as substantial amendments include:

• A change of sponsor(s)
• Appointment of a new Chief Investigator and
• Extension of the research beyond the planned closing date for recruitment

A substantial amendment may not be made to a research study without the favourable opinion from the REC that gave a favourable opinion for the study (the main REC) and as applicable the MHRA. The only exceptions to this rule are:

• The Inclusion of a new research site or
• The Appointment of a new PI at an individual site

Both of these qualify as substantial amendments but as they require further SSA and approval from the REC there is no requirement for notice of amendment to the REC. These changes do still however need to be notified to the MHRA (as applicable)

Site Specific Information: local detail to inform SSA including qualifications/expertise of the PI and wider research team, study procedures, departmental capacity to absorb project (includes Pharmacy, Pathology, Radiology) and departmental leads signatures; The SSI form is completed in IRAS

Site Specific Assessment: An assessment performed to establish the suitability of a Principal Investigator and a site for the conduct of research; SSA will be performed by the Participating CLRN for each research site (NHS organisation), using an SSI form available in IRAS

Stroke Research Network