Skip to main content

You are here

Study Type

Health research can fall into many different categories, from Clinical Trials of Investigational Medicinal Products (CTIMPs) through to studies limited to working with data only.  The design of the study (the study type) must be appropriate to answer the research question being posed. 

Different types of research have different risks and benefits associated with them which need to be addressed by the Chief Investigator and assessed by Noclor when considering sponsorship (by a Noclor partner). Noclor applies a risk- adaptive approach to sponsorship and management of research; it is therefore important that research is categorised correctly from the outset to ensure that any information requested by Noclor during the initial discussions in regards to sponsorship and risk assessment are appropriate to the type of study type.    

Below are some of the key questions you may want consider:

Is my study research or audit?

In the first instance it is important to differentiate health research from audit and service evaluation.  To help you decide whether your project is classified as health research within the scope of the UK Policy Framework for Health and Social Care Research please refer to the HRA Decision Tool. This on-line tool comprises of a short series of YES and NO questions (based on the Defining Research leaflet).  Once you have answered the questions the tool will let you know if your study is research.  If the project is solely audit or service evaluation, or some other type of non-research activity such as a satisfaction survey, please contact the relevant NHS Clinical Governance Office.

Is my study a CTIMP?

It is important to identify clinical trials which fall within the scope of the Clinical Trial Regulations (Clinical Trials of Investigation Medicinal Products) early on in the design process as this type of research is regulated in the UK by The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031). It is a criminal offence to conduct a CTIMP anywhere in the UK without Clinical Trial Authorisation (CTA).  If you are unsure as to whether your proposed research falls within the scope of the Regulations then please refer to the MHRA algorithm. If, after using the algorithm you are still unsure as to whether your research falls within the scope of the Regulations contact the Noclor Sponsor Representative. Noclor may send your protocol to the MHRA Clinical Trials Helpline for a ‘Protocol Scope – Review’. 

Which research category is my study?

All health research should be classified according to the research categories defined in IRAS (Project Filter Question 2).  To assist you in assigning the correct category (study type) to your research study, IRAS provides detailed guidance on each study type in their Collated Guidance - Project Filter.  On-line guidance is also available if you have an IRAS account.

The HRA provide additional guidance and toolkits on their resource pages about the different types of research studies including reference to research involving medical devices, ionising radiation and human tissue.

It is important that researchers understand which category their research is as there will be different requirements (some legal if a CTIMP) and expectations of the Chief Investigator throughout the life cycle of the research study based on the specific study category.

It is also worth noting that research categories can often be grouped together in general communication and guidance under broader ‘umbrella’ terms (such as clinical trials, non-interventional studies, all other research etc). The requirements for a specific study category will always take precedence over those of a group (i.e if there are differences or additional requirements to those of the group).