Clinical Trial Amendments

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Clinical Trial Amendments

Notification of Clinical Trial Authorisation Amendment

The following guidance applies to all Clinical Trials of an Investigational Medicinal Product (CTIMP) that are being sponsored by the Leeds Teaching Hospitals NHS Trust or University of Leeds.

It is a statutory requirement for the Sponsor for a CTIMP to decide whether a clinical trial amendment is substantial or non-substantial , therefore any amendments to an approved clinical trial must be notified to the Sponsor prior to submission to the MHRA and Main REC.

This guidance applies when:

An amendment to the Clinical Trial Authorisation is required
An amendment to the terms of the REC application is required
An amendment to the Protocol is required
An amendment to other trial documentation or particulars reviewed and approved by the MHRA or Main REC, during the initial or any subsequent reviews is required.

The Investigator is responsible for undertaking the actions highlighted in green

Sponsor Approved Template or Checklist

Complete Sponsor

Notice of Amendment

Request to Sponsor for

Clinical Trial Amendment Template

Supplemental Page

Fax to Sponsor

0113 392 2863

Sponsor Review

of amendment (s)

Sponsor faxes

decision to CI

Substantial amendment

Non-substantial amendment

Amend documents as required

Submit to Main REC and MHRA

Annex 2 Template

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Submission of a Substantial Amendment to the Main REC and MHRA

The Chief Investigator should submit a valid notice of amendment to the MHRA and the main REC that gave the favourable opinion to the trial; using the EU Notification of Amendment Form ( Annex 2 Template).

The Annex 2 must be accompanied by the documents that have been modified, showing both the previous and new wording, a summary document detailing each amendment and the rationale to support it is usually the clearest way to explain the amendments, for example:

Amendment A

Previous document name and version number

Page. Previous wording

New document name and version number

Page. New wording

Rationale

The Annex 2 must be signed in ink by the applicant.

It should be indicated on the first page of the Annex 2 document whether the amendment is for:

Request for authorisation to the competent authority
Request for opinion of the ethics committee
Notification for information only to the competent authority or ethics committee

The amendments may not be actioned until the MREC and MHRA have issued their approval/acknowledgment letters and copies of the letters have been received by the Sponsor.

Notification of Urgent Safety Measures

An urgent safety measure may be any measure taken in order to protect the subjects of a CTIMP against any immediate hazard to their health.

The decision to undertake appropriate safety measures may be taken by:

The Sponsor
The Chief Investigator
The Principal Investigator

The Investigator is responsible for undertaking the actions highlighted in green

Sponsor Approved Template or Checklist

Urgent Safety Measure

Within 24 hrs of Urgent Safety measure

Within 3 days of urgent safety measure

Notify MHRA by Telephone

Notify Sponsor by fax 0113 392 2863

Notify MHRA in writing

Sponsor Notification of Urgent Safety Measure

Fax Template

The Sponsor will acknowledge receipt of the fax, either by telephone, email or fax; if notification of receipt is not received from The Sponsor within 1 week, then the Chief Investigator must contact the Quality Assurance Department directly to check that the notification fax has been received.

The Chief Investigator may initiate the urgent safety measure(s) prior to receiving the confirmation of receipt from The Sponsor. The MHRA will notify the Chief Investigator as to whether an application for a clinical trial amendment should be made. Any amendments must be notified to the Sponsor prior to submission.

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