STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Preparation of a Clinical Trial Authorisation Application

SOP Number

Insert Number

SOP Title

Preparation of a Clinical Trial Authorisation Application

NAME

TITLE

SIGNATURE

DATE

Author
Reviewer
Authoriser

Effective Date:
Review Date:

READ BY
NAME

TITLE

Adapted from CTRG Template SOP version 4.1

Copyright: The University of Oxford 2009

SIGNATURE

DATE

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STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Preparation of a Clinical Trial Authorisation Application

This SOP has been written as an example which can be adapted for use in any department
conducting clinical research where there are no SOPs in place. The contents of the SOP
should be reviewed in conjunction with the procedures which take place within the
department and the text should be altered accordingly.
Delete highlighted text before finalising the document.

1.

PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the standard
procedures to be followed when preparing a Clinical Trial Authorisation application for
clinical studies sponsored by the University of Oxford.

2.

INTRODUCTION
An algorithm has been produced by the MHRA which can be used to help determine
whether a study is a clinical trial.
Any Clinical Trial in the UK which falls within the scope of the EU Clinical Trial
Directive 2001/20/EC needs to have authorisation from the Medicines and Healthcare
Products Regulatory Agency (MHRA). A Clinical Trial Authorisation (CTA) form should
be completed to obtain this authorisation.
Prior to applying for the CTA, a EudraCT number must be obtained for all clinical
studies and this must be included on all clinical trial authorisation applications.

3.

SCOPE
This SOP applies to clinical trials where the University of Oxford has accepted the
role of Sponsor, in the INSERT NAME department/ for the INSERT NAME/NUMBER
trial (delete as appropriate)
This SOP does not apply to commercially sponsored research or research sponsored
by an external non-commercial organization.

4.

RESPONSIBILITIES

4.1

Investigator or delegate
To prepare a CTA and submit it to the MHRA.

4.2

Clinical Trials and Research Governance (CTRG)

To delegate responsibility for CTA application to the investigator or designee.
To provide advice/assistance with the preparation of the CTA as necessary.

5.

PROCEDURE

5.1

Obtaining a EudraCT Number

Before submitting a CTA, a EudraCT Number must be obtained. EudraCT is a
database of all International clinical trials of medicinal products. The EudraCT number
will be a unique reference for each trial. The number must be included on the clinical

Adapted from CTRG Template SOP version 4.1

Copyright: The University of Oxford 2009

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STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Preparation of a Clinical Trial Authorisation Application

trial authorisation application to the MHRA and all other documentation related to the
trial.
A EudraCT number can be applied for at:
eudract.emea. eu.int
5.2

Complete Application Form

The application form is accessed through the Integrated Research Application
System (IRAS). See SOP on ethics applications.
It is recommended that the integrated dataset is completed as this will populate all the
relevant forms for the project (including the EudraCT application form for MHRA
application). Once all the data has been entered, select the MHRA Medicines
(EudraCT application) form from the list and follow instructions on the submission tab
to prepare your application for submission.

5.3

Submission
An authorisation request should be submitted to the MHRA including the following:

A covering letter including EudraCT number, Trial identification code, Title of

trial (all in the heading) and details of any special issues such as special trial
populations or unusual IMPs.

Application Form (as .XML and .PDF files this is done by clicking on the
proceed to submission button)

Protocol

Investigators brochure/IMPD/SmPC (as applicable)

Application fee

Other information including details of any other competent authorities to which

the same application has been submitted with details of their decisions and a
copy of the opinion of the ethics committee when available. Examples of
labels for trial supplies must be submitted to the MHRA.

A copy of all documents should be taken and filed in the Trial Master File.

5.4

IMPD (Investigational Medicinal Product Dossier)

An IMPD provides information on the quality of test products, comparators and
placebos to be used in a clinical trial.
An IMPD is not required if:

the IMP in a study is a licensed medicine which is being used in the same
form, for the same indication and with a dosing regimen covered in the
Summary of medicinal Product Characteristics (SmPC) In this case the
SmPC can be submitted instead.

the dosing regime is not covered by the SmPC, but it can be shown that the
information in the SmPC justifies the safety of the proposed new regimen.

A full IMPD must be submitted for:

Adapted from CTRG Template SOP version 4.1

Copyright: The University of Oxford 2009

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STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Preparation of a Clinical Trial Authorisation Application

IMPs without a marketing authorisation in any Member State

IMPs where the MHRA has not granted a CTA previously

IMPs where relevant information from another Sponsors application for the
same product cannot be cross-referred.

A simplified IMPD should be submitted for:

IMPs that have been assessed previously either as a marketing authorisation

or as a CTA.

Details of requirements for IMPDs can be found at the website link above.
Information should be obtained from the manufacturer of the IMP.
5.5

Response
MHRA must provide an initial response within 30 days of receipt of the application
(either an authorisation or a request for submission of an amended application)
If required, the amended application must be submitted within 15 days of receipt of
the request.
MHRA must provide a response within a total of 60 days from receipt of the original
application (except for trials involving medicinal products for gene therapy, somatic
cell therapy or medicinal products containing genetically modified organisms where
the timeframe is 90 days).
All correspondence with the MHRA should be filed in the Trial Master File.

5.6

During the Trial

The MHRA should be notified during the study if there are any new study sites, new
investigators or investigators who have withdrawn from the study. Protocol
amendments should be approved by the MHRA before being implemented (see SOP
). Also see SOP for details of safety reporting requirements to the MHRA during
the trial.

6.

FORMS TO BE USED
Where Forms/Templates are referenced in the text, the numbers and titles are listed
under this section.

7.

INTERNAL AND EXTERNAL REFERENCES

This section is used to list all controlled internal references (e.g. SOPs) and external
references referred to within the text of the SOP only.

7.1

Internal References

7.2

External References
ICH Harmonised Tripartite Guideline for Good Clinical Practice.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
on the approximation of the laws, regulations and administrative provisions of the

Adapted from CTRG Template SOP version 4.1

Copyright: The University of Oxford 2009

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STANDARD OPERATING PROCEDURE

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SOP No: Insert Number

Draft SOP Title: Preparation of a Clinical Trial Authorisation Application

Member States relating to the implementation of good clinical practice in the conduct
of medicinal products for human use.

8.

CHANGE HISTORY
Where the SOP is the initial version:

The SOP number is recorded.

Initial version is noted in the Significant section.

Where replacing a previous SOP:

The Effective Date for the previous version is recorded against that version in
the table.

Record the new SOP number; record the Effective Date as See page 1.

Main changes from the previous SOP(s) are listed under Reason for
Replacement, in sufficient detail to provide guidance for training.

If the SOP replaces a previous version or another procedure, the SOP number
for the document is listed in the Previous SOP No. column (see section 12 of
this SOP for an example).

SOP no.

Effective
Date

Adapted from CTRG Template SOP version 4.1

Copyright: The University of Oxford 2009

Significant Changes

Previous
SOP no.

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