Clinical Trials
IRAS

Getting Started

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Registration of a Clinical Trial


Prior to submitting a Clinical Trial Application (CTA) to the Competent Authority, the sponsor, or their authorised representative has to obtain a EudraCT number. This number will identify whether it is a single site or a multi-site trial conducted in one or more member states.This central database holds information of all trials that have commenced in the European Community from 1 May 2004 onwards. It was established in accordance with Directive 2001/20/EC. EudraCT database.

The unique identifier should be used on all documentation relating to the trial.The data entered on the EudraCT database can only be accessed by the MHRA/Competent Authorities. Within the UK the MHRA is the Competent Authority, within the EU other countries will have their own Competent Authority.

For clinical trials that involve a medicinal product a Clinical Trial Authorisation (CTA) is required. The application for a CTA is completed via IRAS.


IRAS Integrated Research Application System

Within the UK, an integrated way of completing the necessary approval forms was launched in 2008. It is expected that use of The Integrated Research Application System (IRAS) will become mandatory. IRAS is a is a single system for applying for the permissions and approvals for health and social care / community care research in the UK including clinical trials. It enables researchers to enter information about their project once instead of duplicating information in separate application forms. It applies filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required.

IRAS captures the information needed for the relevant approvals from the following review bodies:
· Administration of Radioactive Substances Advisory Committee (ARSAC)
· Gene Therapy Advisory Committee (GTAC)
· Medicines and Healthcare products Regulatory Agency (MHRA)
· Ministry of Justice (National Offender Management Service)
· NHS / HSC research offices
· NRES/ NHS / HSC Research Ethics Committees
· Patient Information Advisory Group (PIAG)
Although not yet fully integrated, applications to MHRA for Clinical Trial Authorisation can also be submitted via IRAS.

Funding of Clinical Trials

All research needs to be funded prior to starting. Details of all costs involved in the research needs to be considered and funding sought from the local R and D department. NHS organisations apply for and receive funding on an annual basis.

The Chief Scientists Office (CSO) has some useful information and details of information relating to Support for Science, Support Grants and Eligible Funders. For information relating to funding please contact your local R and D Department. Executive Summaries of research funded from the CSO are also available.

Ethics Information

The National Research Ethics Service (NRES) provides information relating to the procedures to gain ethical approval.

During the trial, any Serious Unexpected Suspected Adverse Reactions (SUSARs) may be reported electronically onto the EudraVigilance database that facilitates the tracking of safety data from the clinical trials registered on the EudraCT database.
The EudraVigilance database which has been running since 2001, is like the EudraCT database and is a common European database containing information on adverse reactions in humans, animals and in clinical trials.

End of trial documentation may also be downloaded from the:

Completion and Development of Local Documentation


After the sponsor has requested the unique EudraCT number from the EudraCT database and has contacted the local Research and Development Office for further guidance then consideration needs to be given to further local documentation that is required to be completed/developed before the actual clinical phase of the clinical trial formally starts.

All documentation needs to be held in the appropriate clinical trial file for the duration of the study. After the study has ended, all essential documentation should be archived as per local procedure and retained  for the  approved recognised period.

Medicines Involved in a Clinical Trial (CTIMP )

Medicines need to hold marketing authorisation (MA) prior to the medicine being marketed. Medicines, which meet the standards of safety, quality and efficacy, are granted a marketing authorisation (previously a product licence), which is normally necessary before they can be prescribed or sold. Unlicensed medicines and IMPS used in clinical trials do not have a UK marketing authorisation and different regulations apply to unlicensed and clinical trial medicines respectively. Clinical trials are undertaken on new medicinal products to ensure that when the product is available for the population at large that it is deemed safe for the intended licensed indications.

Some medicines named in a clinical trial protocol may already hold a UK Marketing Authorisation and hence may already be available on the market, but may be being tested for an indication / dosage out with the marketing authorisation.

Alternatively the medicine may already hold a UK Marketing Authorisation and is perhaps not being tested at all, but may be required to facilitate the trial. In this case the effect of the medicine is not being measured and it will be being used within its licensed indication and dose (Non Interventional Clinical Trial). e.g. an investigator may require to examine the retina of the patient's eye to see if the medicine under investigation has caused any changes to the patient's retina. In order to examine the retina at the back of the patient's eye, he/she needs to dilate the patient's pupil. The drug used to dilate the pupil is not under investigation and is merely a tool to faciltate the research.

For marketing authorisation information out with the UK,   the European Medicines Evaluation Agency (EMEA) can certify if an application for authorisation has been submitted via the centralised procedure.


When a product has been authorised by the EU member state, then a certificate detailing the authorisation will be issued by the national authority granting the marketing authorisation e.g. the MHRA.

One should note that the manufacture of 'non  - commercial' clinical trial materials  e.g. by a local manufacturing unit also require authorisation (MA CTIMP). This is required whether the manufacturer is blinding, labelling or simply assembling the medicinal product for the clinical trial. Local manufacturing units require a manufacturing licence to be able to manufacture clinical trial materials.

Manufacturers of IMPs

Manufacturers of IMPs for use within a clinical trial are now required to hold a Manufacturing Authorisation for Investigational Medicinal Product  (MIAIMP). The MHRA maintains a list of licensed manufacturers within the UK which includes what activities they are licensed to undertake. The regulations include information on what is defined as ‘manufacture’ and what is defined as ‘assembly’. A license is not required for the assembly of investigational medicinal products. The Medicines for Human Use Regulations (Clinical Trials) give precise meanings of ‘assemble’ and ‘manufacture’.

Assemble, in relation to an investigational medicinal product, means—
(a) enclosing the product (with or without other medicinal products of the same

      description) in a container which is labelled before the product is sold or supplied, or

      used in a clinical trial, or
(b) where the product (with or without other medicinal products of the same description)

      is already contained in the container in which it is to be sold or supplied, or used in a

      clinical trial, labelling the container before the product is sold or supplied, or used in

      a clinical trial, in that container,

Manufacture, in relation to an investigational medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting it or mixing it with, some other substance used as a vehicle for the purposes of administering it.