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How do I submit an amendment?

ALL SUBSTANTIAL AMENDMENTS MUST BE REVIEWED BY YOUR RIS DEPARTMENTAL OFFICER PRIOR TO SUBMISSION

 

Non-CTIMP

You should summarise the change(s) included in the amendment and briefly explain the reasons in each case on the notice of amendment. It is important that you complete the form using language comprehensible to a lay person. You should submit the documents that have been modified, showing both the previous and new wording, with the form. Where the modified documents (for example, the study protocol) are lengthy and the changes are not so widespread or significant as to justify a new version, you can provide extracts or list the changes in a separate document.

Multisite Studies: In the case of multi-site studies, you should not send copies of notices of substantial amendment to other RECs unless specifically notified to do so by the main REC.

The sponsor or chief investigator may also include other supporting information, such as a summary of trial data, an updated safety analysis or a report from a trial monitoring committee. Where the amendment could significantly affect the scientific value of the research, you should provide further evidence of scientific and/or statistical review.

Non-CTIMP substantial amendment form(Word Document)

CTIMP

The notification of a substantial amendment should be submitted to the original approving NHS REC and include the following:

(a) a signed cover letter, including:

  • in its subject line the EudraCT number and the sponsor protocol number (if available) with the title of the trial and the sponsor’s amendment code number allowing unique identification of the substantial amendment. Care should be taken to use the code number consistently;
  • identification of the applicant;
  • identification of the amendment (sponsor’s substantial amendment code number and date). One amendment could refer to several changes in the protocol or scientific supporting documents;
  • a highlighted indication of any special issues related to the amendment and indication where the relevant information or text is in the original application dossier;
  • identification of any information not contained in the Amendment Notification Form that might impact on the risk to trial participants;
  • where applicable, a list of all affected clinical trials with EudraCT numbers and respective amendment code numbers (see above);

(b) the Amendment Notification Form, as amended, which is published in Volume 10 of EudraLex

  • The Rules Governing Medicinal Products in the European Union. Only this Amendment Notification Form should be used;

(c) a description of the amendment:

  • an extract from the amended documents showing previous and new wording in track changes, as well as the extract only showing the new wording;
  • notwithstanding the previous point, if the changes are so widespread or far-reaching that they justify an entire new version of the document, a new version of the entire document. In this case, an additional table should list the amendments to the documents. In this list, identical changes can be grouped. The new version should be identified with the date and an updated version number.

(d) supporting information including, where applicable:

  • summaries of data,
  • an updated overall risk/benefit assessment,
  • possible consequences for subjects already included in the trial,
  • possible consequences for the evaluation of the results;

(e) if a substantial amendment involves changes to entries on the clinical trial application form, a revised copy of the XML file incorporating amended data. If the form is not submitted via a telematics system, the fields affected by the substantial amendment should be highlighted in the revised form.