Back
to leedsth.nhs.ukResearch & Development Website
Definitions
Non-interventional study: To classify a trial as non-interventional, it must meet all of the following criteria:
• are studies involving products with a marketing authorisation that are prescribed in the usual manner and used in accordance with the authorisation;
• when the patient is assigned to a therapeutic strategy within current practice and not according to a protocol;
• the diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy;
• and epidemiological methods are used to analyse the data.
If a study
is not for the purpose of ascertaining the effects of or reactions to a product
and the product is simply being used as an aid or tool in the study, it is not
a clinical trial covered by the Regulations. For example, in the case of the
study of blood flow involving the infusion of vasoactive substances, if the
purpose of the study is to monitor the effects of a particular substance to
see if it is effective in achieving a particular physiological effect, then
it is not a clinical trial. If the infusion is for the purpose of modifying
the rate of flow for a therapeutic indication such as claudication, it would
be deemed a trial under the Directive as the purpose of the study is to establish
the efficacy of a particular medicine.
Sponsor: Under the UK Regulations, the
Sponsor is an institution or individual that takes responsibility for the initiation,
management and financing (or arranging financing) of a study.
Confirmation of Sponsorship and Study approval letter
Chief Investigator:
Sponsor ID Number: A unique ID number assigned by the Quality Assurance Department during the initial review process of the clinical trial. The Sponsor ID must be detailed on all trial related documentation and correspondence.
Investigational Medicinal Product
If your trial involves Investigational Medicinal Products you need to establish whether it will fall within the scope of the Medicines for Human Use (Clinical Trials) Regulations 2004 . If the trial does fall under the regulations, there are a number of additional requirements that must be met before the trial begins Research Sponsor Guidance
Trials that fall within the scope of the UK Clinical Trials Regulations must involve medicinal products. However non-interventional trials are excluded from the Regulations. To classify a trial as non-interventional, it must meet all of the following criteria:
- It must involve product(s) with a marketing authorisation that are prescribed in the usual manner and used in accordance with the authorisation
- The patient must be assigned to a therapeutic strategy within current practice and not according to a protocol
- The diagnostic or monitoring procedures used must only be those ordinarily applied to the therapeutic strategy
- and epidemiological methods are used to analyse the data.
If a study is not for the purpose of ascertaining the effects of or reactions to a product and the product is simply being used as an aid or tool in the study, it is not a clinical trial covered by the Regulations. (Definitions obtained from the DH/MRC Clinical Trials Toolkit )
If you are uncertain whether the trial falls under the Clinical Trials Regulations please contact the Medicines and Healthcare Products Regulatory Agency's
:
clintrialhelpline@mhra.gsi.gov.uk
SUSAR
SAE
AE
Multicentre study
Sops
Double blind
SAE and SUSAR Review: review procedures will be specific to the trial and the trial specific SOP should be referred to for specific details. The CI must review all SAEs and SUSARs on an ongoing basis within the trial. For larger trials and those involving an IMP used outside of it's licence the sponsor requires that an independent committee such as a DMEC is set up to review all SAEs ad SUSARs occurring within the trial. The DMEC or other independent committee must have clearly defined roles and responsibilities defined prior to the start of the trial.
CTIMPS
Adverse Drug Reaction – In the pre-approved clinical setting, an ADR is defined as all “noxious and unintended responses to a medicinal product, related to any dose should be considered adverse drug reactions”.
Adverse Event - This is defined under ICH/GCP as “Development of a new medical condition or worsening of a pre-existing medical condition during or following administration of an Investigational Product”.
The adverse event does NOT necessarily have a causal relationship with treatment.
The term medical condition can include:
A new condition / disease diagnosis (e.g. osteoarthritis, diabetes)
Symptoms (e.g. nausea, chest pain)
A sign (e.g. rash, enlarged liver)
Abnormal result of investigations (e.g. abnormal scans / x-rays)
Worsening of any of the above.
Investigator Brochure (IB) – A compilation of the clinical and non-clinical data on the investigational medicinal product
Investigational Medicinal Product (IMP) – Any reference product or active comparator, as specified in the protocol and on the Clinical Trial Authorisation letter from the MHRA
Any other treatments given as supportive care would not require to be named as an IMP as they would not considered to be protocol treatment.
Serious Adverse Event (SAE) – This is defined in accordance with ICH/GCP as “Any untoward medical occurrence that:”
Is fatal or life threatening
Requires hospitalisation or prolongs existing hospitalisation
Results in significant or permanent disability or incapacity
Is a new primary cancer
Is a congenital anomaly or birth defect
May jeopardise the patient and may require medical or surgical intervention to prevent one of the outcomes listed above”
Suspected Serious Adverse Reaction (SSAR) – A serious adverse drug reaction that demonstrates the following characteristics:
An adverse event judged by either the Principal Investigator (PI) at site / the Chief Investigator / study sponsor as having reasonable suspected causal relationship to the Investigational Medicinal Product (IMP). The expression “reasonable causal relationship” should convey that there are facts (evidence) or arguments to suggest causal relationship (i.e. This is an adverse drug reaction to the IMP that also fits the criteria of being serious.
Suspected Unexpected Serious Adverse Reaction (SUSAR) – A serious adverse drug reaction that also demonstrates both the following characteristics:
Suspected – An adverse event judged by either the Principal Investigator (PI) at site / PI for study or the sponsor as having a reasonable suspected causal relationship to the medicinal product. The expression “reasonable causal relationship” should convey that there are facts (evidence) or arguments to suggest a causal relationship.
Unexpected – An adverse event, the nature OR severity of which is NOT consistent with the applicable product information (e.g. refer to the current “Summary of Product Characteristics” to determine the expected nature). SAEs listed under the summary of product characteristics could still be classified as unexpected if the nature or severity is deemed by an authorised medic to be unexpected.
Summary of Product Characteristics – Details of a medicinal product, which may list the following:
Composition
Therapeutic indication
Contra-indications
Known / suspected drug interactions
Undesirable effects
Specific listings of adverse events (these may only include specific grades of events observed in a certain % of subjects)
Pharmacological / pharmacokinetic properties
Pre-clinical safety
List of excipients
Shelf life
Storage precautions
Nature and contents of containers
Instruction for handling and use
Marketing Authorisation number / holder details
Date of first Marketing Authorisation and dates SPC text was revised.
Regulatory Authority – In the UK is the MHRA.