Adapted from CTRG Template SOP Version 4.1

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 / SIGNATURE / DATE

Adapted from CTRG Template SOP version 4.1

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

4.1Investigator or delegate

To prepare a CTA and submit it to the MHRA.

4.2Clinical 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

5.1Obtaining 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 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

5.2Complete 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.

5.3Submission

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
Investigator’s 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.

5.4IMPD (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:

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 Sponsor’s 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.

5.5Response

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.

5.6During 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.

7.1Internal References

7.2External 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 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 / Significant Changes / Previous
SOP no.

Adapted from CTRG Template SOP version 4.1