Clinical trials for medicines: manage your authorisation, report safety issues
Source: gov.uk (2025-06-09)

Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.

As of 1 January 2022 the combined review service, formerly known as Combined Ways of Working (CWoW), is now the way that all new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications are prepared, submitted and reviewed. Combined review offers a single application route and co-ordinated review leading to a single UK decision for CTIMPs.

Please note: CTIMP initial applications via combined review should be started and submitted using the new part of Integrated Research Application System (IRAS (http://myresearchproject.org.uk/CWOW)) and not in the standard part of IRAS. While the regulatory requirements and fees remain the same, the application submission, processing and assessment steps outlined below refer to non-combined review applications. For Combined review applications please refer to the Health Research Authority website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/).

Clinical Trials and coronavirus (COVID-19)

We have published guidance on managing clinical trials (https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19) during the COVID-19 outbreak, and on clinical trials applications for COVID-19 (https://www.gov.uk/guidance/clinical-trials-applications-for-coronavirus-covid-19).

Amending your trial protocol or other documentation

You only need to submit substantial amendments to the MHRA. Changes count as a substantial amendment to your clinical trial authorisation if the amendment is likely to affect to a significant degree:

the safety or physical or mental integrity of the subjects of the trial

the scientific value of the trial

the conduct or management of the trial, or

the quality or safety of any investigational medicinal product used in the trial

For clinical trials authorised via the combined review process you should prepare and submit using the Integrated Research Application System (IRAS) (http://www.myresearchproject.org.uk/CWOW).

For clinical trials not approved or yet transitioned over to the combined review process, you should continue to use MHRA submissions (https://www.gov.uk/guidance/register-to-make-submissions-to-the-mhra).

You need to send the following documents to the MHRA.

a) A covering letter detailing the trial reference numbers (IRAS ID, CTA number, EudraCT) along with purchase order number, outlining the substantial changes (if there have been any non-substantial changes, outline these separately).

b) A PDF copy of the locked amendment tool (https://www.myresearchproject.org.uk/help/hlpamendments.aspx#Amendment-Tool). You should ensure that the amendment tool contains a clear description of the substantial amendment and reasons for the proposed changes. Alternatively, for ‘bulk’ amendments (where the same change affects many trials), you can complete and submit the substantial amendment notification form (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1028249/substantial_amendment_notification_form_.doc)*.

c) A PDF file of the clinical trial authorisation application form (https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#clinicaltrialapplication)* generated in IRAS with changes highlighted, if the amendment affects the information previously submitted.

d) A list of the proposed changes to the protocol or any other documents such as investigational medicinal product dossier (IMPD) compared to the current MHRA-approved document, showing previous and new wording where applicable and a rationale to justify each substantial change. If applicable, you should provide: - summaries of data - updated overall risk benefit assessment - possible consequences for subjects already in the trial - possible consequences for the evaluation of results

Assessment process

We will assess your application within 35 days. If you consider your trial requires an expedited assessment (for example, patient safety reasons), you should state this in the covering letter along with the rationale for the expedited assessment request.

Invalid applications

If your application does not meet the requirements it will not be assessed. We will tell you the reasons why your application is invalid.

Check the common issues identified during clinical trial applications guidance (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/318027/Common_errors_seen_at_validation.pdf) (PDF, 43KB, 1 page) to ensure you’re submitting a valid application.

For queries about electronic documents and submissions, email xxx@xxx.xx (mailto:xxx@xxx.xx).

Withdraw your application before the final decision

You may withdraw your application at any point before an assessment decision on your substantial amendment is reached. To withdraw your application, email xxx@xxx.xx (mailto:xxx@xxx.xx).

For applications that have gone through the combined review process, refer to the guidance on the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#withdrawing).

Outcome of assessment

We will tell you the outcome of your application by email.

If your application is not successful, we will tell you why and you may resubmit your application.

Fees

There are different fees based on your type of clinical trial application (https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees).

See Make a payment to MHRA (https://www.gov.uk/guidance/make-a-payment-to-mhra) on how to pay relevant fees.

We send invoices for clinical trial authorisation applications, substantial amendment applications and annual safety reports directly to the applicant shortly after a valid submission has been established. The covering letter for the application should clearly highlight your purchase order (PO) number where available. The applicant is the person listed in section C1 of the clinical trial application form, or section D1 of the amendment form. We are unable to address the invoice to someone other than those listed in the sections above.

The applicant is responsible for ensuring timely payment of invoices for their submissions. Invoices must be settled on receipt of invoice. Penalty fees may be incurred for non-payment. Details of the penalties are set out in the Fees regulations (https://www.legislation.gov.uk/uksi/2016/190/contents). Non-payment may also result in suspension of any licence or authorisation, followed by legal proceedings for unpaid amounts, as a debt due to the Crown.

Please see MHRA payments page (https://www.gov.uk/guidance/make-a-payment-to-mhra) for further information on how to pay MHRA.

Change your contact details

For applications that have gone through the combined review process, refer to the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#amendment).

Send an email entitled ‘Change to contact details of the contact person CTA number XXXXX/XXXX/XXX-XXXX – EudraCT number XXXX/XXXXXX/XX – IRAS ID XXXXXXX’.

Email: xxx@xxx.xx (mailto:xxx@xxx.xx)

The email should be sent by the contact person listed on the current application form, or other authorised persons, and must include:
- IRAS ID and/or EudraCT number
- CTA number
- details of the previous contact person and/or contact details
- details of the new contact person and/or contact details
Update the contact person or details on an updated application form. Include a copy of the updated application form in the next substantial amendment.

Change of legal representative

For applications that have gone through the combined review process, refer to the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#amendment).

If you want to change the legal representative for your study, you must submit a substantial amendment to the MHRA. You may include other changes along with this amendment but must you ensure the covering letter clearly highlights there is also a change of legal representative. The submission must include a clinical trial application form updated with the details of the new legal representative along the amendment tool.

There is no fee for this kind of submission unless other, additional amendments to the trial documentation are included.

Change of sponsor

For applications that have gone through the combined review process, refer to the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#amendment).

If you want to change the sponsor for your study, you must submit a substantial amendment to the MHRA. You must not include any other changes with this amendment.

You cannot submit any other substantial amendments until you have confirmation from the MHRA that the sponsor has been changed.

You must include these documents with your submission:
- a cover letter that includes the date of transfer of responsibilities
- a letter on headed company paper from the current sponsor confirming the transfer of the study
- a letter on headed company paper from the new sponsor confirming that they accept the role of sponsor for this study
- an amendment form
- an updated PDF file of the clinical trial application form signed by the new sponsor or person acting on behalf of the sponsor
You should not submit other trial-related documents such as protocol as part of this submission. There is no fee for a change of sponsor amendment. The applicant will receive an administrative letter confirming that the change has been registered. You do not need to wait for MHRA confirmation before making the sponsor change.

Clinical trials named contact

Effective from 27 June 2016, persons other than the applicant named in the trial application form, who call or email the MHRA CTU helpline, reporting to be from the sponsor/applicant company knowing the EudraCT number and security word/phrase (previously provided to the MHRA by the named applicant) for a trial, may obtain information on that trial.

For ongoing studies, the applicant named in section C.1 of the application form should notify the Clinical Trials Unit of their chosen security word/phrase by emailing xxx@xxx.xx (mailto:xxx@xxx.xx) with ‘Clinical trials named contact’ as the subject line and listing the EudraCT number(s) in the body of the email.

For new applications, the applicant named in section C.1 of the application form should include the security word/phrase in the cover letter for the submission.

Reference safety information – updated guidance

Published guidance such as CT1 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52010XC0330(01)) and CT3 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52011XC0611(01)) and the CTFG Q&A (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2017_11_CTFG_Question_and_Answer_on_Reference_Safety_Information_2017.pdf) on reference safety information (RSI) remain applicable as a source of materials for understanding what the obligations entail in so far as they relate to the UK as a sovereign regulator. This will also help facilitate acceptance of the RSI in multinational clinical trials.

Additional guidance is available in Reference safety information (RSI) for clinical trials- part III - MHRA Inspectorate (blog.gov.uk) (https://mhrainspectorate.blog.gov.uk/2021/02/05/reference-safety-information-rsi-for-clinical-trials-part-iii/).

UK-specific clarifications

In accordance with current expectations, for trials that are being conducted in the UK, an RSI cannot be used for expectedness until it has approval from the MHRA. Thus, if additional suspected unexpected serious adverse reactions (SUSARs) occur before the new RSI is approved, these should be reported as SUSARs in the usual expedited manner. If sponsors wish to harmonise the implementation date of an RSI in a trial that includes EU and UK sites, then this can be the date where approval has been granted in all member states and the UK. In the interest of efficiency and harmonisation for multinational trials, we recommend that you submit amendments, including changes to the RSI, to the UK and EU at the same time

You should use the RSI approved by the regulatory authority at the time of occurrence of the ‘suspected’ SAR to assess expectedness for both initial and follow-up reports.

For DSURs the sponsor should use the RSI that was approved at the beginning of the reporting period by both the MHRA and European member states.

Urgent safety measures

To determine whether the action you are taking is an urgent safety measure (USM), refer to regulation 30 of the Statutory Instrument (SI) 2004 Number 1031 (as amended).

Call the MHRA Clinical Trials Unit on xx-xxxx-xxxx to discuss the issue with a medical assessor, ideally within 24 hours of measures being taken. Please call no later than 3 days from the date the measures are taken.

Information you will be asked for on the call:

the IRAS ID and the EudraCT number of:

the trials for which USM action has been taken

other ongoing trials with the same investigational medicinal product(s) (IMP(s))

trials run by a different sponsor affected by the USM action

the affected IMP(s) - commercial or development names

the nature of the safety concern and whether it has been reported as a SUSAR

which USMs have been taken and when

the number of UK subjects who are currently receiving the IMP, the number of subjects who received it and the number affected by the USM

contact details in case of further questions

Where this information is not available during the initial call, you should provide it as soon as possible.

After discussing the USM with the MHRA assessor via phone, you must provide the MHRA with written notification of the measures taken and discussed with the medical assessor within 3 days from the date the measures were taken.

For trials not approved via combined review, you will be instructed to send an email to the medical assessor who assessed the USM over the phone: xxx@xxx.xx (mailto:xxx@xxx.xx).

If at least one of the trials covered by the USM has gone through the combined review process, submit the USM written notification via IRAS (http://www.myresearchproject.org.uk/cwow). More information is available on the Health Research Authority (HRA) website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#reporting).

Notification of a substantial amendment (amendment tool plus any updated document including the changes agreed with the medical assessor) is also required. You should submit the substantial amendment covering the changes made as part of the USM within approximately 2 weeks of notification to the MHRA.

You should discuss and agree any potential reason for delay to submission of the substantial amendment with the medical assessor at the time of initial notification or through a follow-up call.

The USM-related substantial amendment must not include changes different from those required as an urgent safety measure. This is due to the fact that unrelated changes may result in rejection.

Submit your substantial amendment using MHRA Submissions (https://www.gov.uk/guidance/register-to-make-submissions-to-the-mhra) via the Human Medicines Tile. Select ‘Clinical Trial’ as the Regulatory Activity and ‘CT - Amendment’ from the Regulatory Sub Activity dropdown list.

If your trial has gone through the combined review process, you should submit the substantial amendment via IRAS. More information on how to submit a substantial amendment via IRAS (https://www.myresearchproject.org.uk/CWOW) is available on the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#amendment).

If you are not able to report a USM to the MHRA via the phone, email xxx@xxx.xx (mailto:xxx@xxx.xx) within 3 days of taking urgent measures. The subject of the email will be ‘USM for trial IRAS ID/EudraCT number’. Explain in the email:

the USM implemented

the reason

why you did not report it via phone

An MHRA assessor will contact you and provide advice regarding further actions.

Suspected unexpected serious adverse reactions (SUSARs)

The sponsor of the trial, or any other person the sponsor has delegated this responsibility to, must report all suspected unexpected serious adverse reactions (SUSARs) which happen during the course of the trial to the MHRA.

You must report fatal or life-threatening SUSARs as soon as possible, but no later than 7 days after you are first aware of the reaction. You must send any additional relevant information within 8 days of the initial report.

You must report non-fatal or non-life-threatening SUSARs as soon as possible but no later than 15 days after you are first aware of the reaction.

The sponsor of a ‘trial performed in the UK’ (UK trial) must report the following UK-relevant SUSARs to the MHRA:
- all SUSARs occurring in that trial in UK sites
- all SUSARs occurring in that trial in sites outside the UK
- all SUSARs originating in a non-UK trial of the same medicinal product if the trial is run by the same sponsor of the trial running in the UK
- all SUSARs originating in a non-UK trial of the same medicinal product if the sponsor of the trial outside the UK is either part of the same mother company or develops the medicinal product jointly, on the basis of a formal agreement, with the sponsor of the UK trial
You must keep detailed records of all adverse reactions relating to a clinical trial. The MHRA may require you to send copies of records if there is an investigation.

Further information is available in The Medicines for Human Use (Clinical Trials) Regulations 2004, Statutory Instrument 2004 No.1031 (https://www.legislation.gov.uk/uksi/2004/1031/pdfs/uksi_20041031_en.pdf).

Report a SUSAR to the MHRA in one of the following ways.
- Using ICSR Submissions (https://icsrsubmissions.mhra.gov.uk/login), which replaces the EudraVigilance website (EVWEB). The ICSR submissions route is used to submit single reports.
- Using the MHRA Gateway (https://www.gov.uk/guidance/register-to-make-submissions-to-the-mhra#registering-to-use-the-vigilance-systems-mhra-gateway-and-icsr-submissions), which replaces the Eudravigilance Gateway. The Gateway route is used to submit single and bulk reports. To gain access to the MHRA Gateway you need to register to another portal called MHRA Submissions (https://www.gov.uk/guidance/register-to-make-submissions-to-the-mhra).
If applicable, you will need to dual report UK-relevant SUSARs to the European Medicines Agency (EMA) Eudravigilance Clinical Trial Module (EVCTM), as well as to other national competent authorities, using the European submission routes.

Development safety update reports (DSURs)

MHRA fees (https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees#clinical-trials-application-fees) include charges to annual safety reports (DSURs).

We only accept online payment of this fee before submission of an annual safety report. Payment must be made via our dedicated DSUR page (https://www.gov.uk/payments/mhra/dsur) in the pay portal GOV.UK Pay. A receipt generated by the portal following payment will be sent by email to the payee. You must include this in the submission, along with the cover letter and DSUR, in its original format as a standalone document that serves as proof of payment.

Failure to provide evidence of payment will result in the submission being made invalid and sponsors should update their trial master file of this non-compliancy, with corrective and preventative actions to address it.

Further information on navigating the pay portal for DSURs is available in the user reference guide paying online before submitting an annual safety report (https://assets.publishing.service.gov.uk/media/6846eb635e9253957280617e/User_reference_guide___Paying_online_before_submitting_an_annual_safety_report.pdf).

Each submission must contain a cover letter, the DSUR, as well as the emailed receipt that confirms the fee has been paid*.

The cover letter must include:
- a listing of all the IRAS IDs and EudraCT numbers of trials covered by the DSUR
- an email address for correspondence
- the payment reference number in the format: ‘DSUR-[5 digit MHRA company number]-[IMP name]-[Payment date DD/MM/YYYY]’
DSURs should take into account all new available safety information received during the reporting period. The DSUR should include:
- an analysis of the patients’ safety in the concerned clinical trial(s) with an appraisal of its ongoing risk/benefit
- a line listing of all suspected serious adverse reactions (including all SUSARs) that occurred in the trial(s), including all SUSARs from third countries
- an aggregate summary tabulation of SUSARs that occurred in the concerned trial(s)
- region-specific information in accordance with guidelines on how to increase transparency (see below)
Full details of what to include in a DSUR are available in the ICH E2F guidance (https://database.ich.org/sites/default/files/E2F_Guideline.pdf).

*Submissions that reflect a fee waiver will be considered valid. For more information on fees, contact xxx@xxx.xx (mailto:xxx@xxx.xx).

Submitting your report

If your DSUR covers several active trials, submit the report once. You must not submit it multiple times to reflect each trial - this causes duplication in review and leads to multiple fee charges. Sponsors who delegate different contract research organisations (CROs) to submit their DSUR for separate trials will need to take this into consideration. The applicant who performed the submission will then receive an acknowledgement of receipt and case closure email.

Note: the case closure email is an outcome of the review. Applicants must accept invalidations as the final decision and resubmit.

Clinical trials approved through the non-combined review process

If your clinical trial was approved through the non-combined review process, you must submit your DSUR using MHRA Submissions via the Human Medicines Tile. Select ‘Development Safety Update Reports’ as the Regulatory Activity and ‘Original Submission’ from the Regulatory Sub Activity dropdown list.

Clinical trials approved through the combined review process

If at least one of the trials covered by the DSUR has gone through the combined review process, you must submit your DSUR via the IRAS (https://myresearchproject.org.uk/CWOW) platform. You must not submit the DSUR again via MHRA Submissions to account for the other trials that have not been approved by combined review.

If you are experiencing issues entering IRAS IDs for non-combined review trials on the IRAS platform, you must contact the MHRA for further guidance on how to proceed. More information is available on the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#reporting).

At the end of the DSUR reporting period the sponsor may assess the new safety information that has been generated and submit any proposed safety changes to the investigator’s brochure as a substantial amendment. This amendment must be supported by the DSUR and approved before the reference safety information (RSI) is changed.

Guideline on how to increase transparency when presenting safety information in the DSUR: region-specific requirements for Canada and the United Kingdom

To increase the transparency of the data included in DSURs prepared by manufacturers and/or marketing authorisation holders of an investigational drug, the MHRA and Health Canada ask you to use the region-specific information section of the DSUR to explain how safety data was reviewed during the reporting period.

See the Guideline on how to increase transparency when presenting safety information in the DSUR: region-specific requirements for Canada and the United Kingdom (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/993808/DSUR-Guideline-08June2021.pdf) (PDF, 65.6KB, 4 pages) for more details.

Shortened annual safety reports

We are no longer accepting annual progress reports (APRs). You will need to submit a DSUR, completing relevant sections of the report that is applicable to your trial.

Suspend or terminate a trial

The MHRA has the authority to make amendments to an authorisation or in certain circumstances suspend or terminate a trial. The sponsor can contact the MHRA to put a trial on temporary halt or terminate a trial.

Suspend a trial temporarily

If you suspend a trial temporarily you must notify the MHRA.

The notification should be made as a substantial amendment using the amendment tool, clearly explaining what has been stopped and the reasons for the suspension.

Substantial amendments relating to temporary suspension must be submitted using MHRA Submissions via the Human Medicines Tile. Select ‘Clinical Trial’ as the Regulatory Activity and ‘CT – Amendment’ from the Regulatory Sub Activity dropdown list.

For applications that have gone through the combined review process, refer to the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#amendment).

To restart a trial that has been temporarily suspended, you must make the request as a substantial amendment using the notification of amendment form, providing evidence that it is safe to restart the trial.

Early termination of a trial

Complete the end of trial declaration form (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1022119/declaration_end_trial_form_final_29.09.21.doc) (MS Word Document, 60.5KB) and include a brief explanation of the reasons for ending the trial, particularly where the trial has been terminated early. This form must be submitted using MHRA Submissions via the Human Medicines Tile. Select ‘Clinical Trial’ as the Regulatory Activity and ‘CT –EOT’ from the Regulatory Sub Activity dropdown list.

For applications that have gone through the combined review process, refer to the HRA website (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#reporting).

End of trial

A declaration of the end of a clinical trial (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1022119/declaration_end_trial_form_final_29.09.21.doc) must be sent to the MHRA within 90 days of the global end of the trial and within 15 days of the global premature end of the trial. The submission must include an end-of-trial form and a covering letter.

The legislation only requires the global end of trial to be submitted; however, a facility to inform us of the local (UK) end of trial via the end of trial notification form also exists. Local end of trial notifications will not be acknowledged and the MHRA Submissions automatic email confirmation should be considered as evidence of submission. If a local end of trial is submitted, we would still expect to receive relevant safety updates and substantial amendments for the ongoing trial until the global end of trial notification is received.

If you wish to request an exemption to this requirement, you must do it via a substantial amendment for approval. The amendment must clearly state to what documents your proposal relates and provide a robust rationale for the request. All safety documentation must be submitted unless there are no other trials ongoing with the same product in the UK.

Any trial activities (such as follow-ups, visits) must be completed before the submission of the global end of trial declaration form.

It is not possible to submit amendments to the trial or the DSUR once the declaration of the global end of the trial form has been received by the MHRA. If the end-of-trial declaration has been received within a reporting period, or within 60 days following the data lock point, the corresponding DSUR will not be required.

You must submit your end-of-trial declarations using MHRA Submissions via the Human Medicines Tile. Select ‘Clinical Trial’ as the Regulatory Activity and ‘CT – EOT’ from the Regulatory Sub Activity dropdown list.

If your trial has gone through the combined review process, then the end of trial declaration should be submitted via IRAS (https://www.myresearchproject.org.uk/CWOW). More information on how to submit an end-of-trial via IRAS (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#reporting) is available on the HRA website.

Clinical trial summary results

The timeframe for publishing the summary of results is within one year of the end of trial. See also guidance on Completed paediatric studies - submission, processing and assessment (https://www.gov.uk/guidance/completed-paediatric-studies-submission-processing-and-assessment).

Where applicable, you should publish your summary results within this timeframe in the public register (or registers) where you have registered your clinical trial.

You do not need to submit this clinical trial summary report to the MHRA as well. However, you must send a short confirmatory email to xxx@xxx.xx (mailto:xxx@xxx.xx). The subject line of the email notification must state ‘End of trial: result-related information: EudraCT XXXX-XXXXXX-XX’ and/or IRAS ID XXXXXXX’ once the result-related information has been uploaded to the public register. If your clinical trial is not on a public register or the results will not be published in the register (for example an adult phase I study), summary results should be submitted via MHRA Submissions. An acknowledgement letter will not be sent for this submission.

If your trial has gone through the combined review process, then the end of trial declaration should be submitted via IRAS (https://www.myresearchproject.org.uk/CWOW). More information on how to submit an end of trial via IRAS (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/step-step-guide-using-iras-combined-ways-working-cwow/#reporting) is available on the HRA website.

You should also submit a final report to the Research Ethics Committee within the same timeframe for reporting the summary of results.

Sponsors of trials conducted in UK that are already registered in the EU Register are able to submit results to EudraCT. Steps to follow are described in the EMA webpage ‘Tutorials on posting results’ (https://eudract.ema.europa.eu/multimedia_tutorials.html). The MHRA will not be able to update the status of your study in the EU system.

Contact

For information about your submission, including status and tracking enquiries, contact the clinical trials helpline on xx-xxxx-xxxx (Monday to Friday 8:30am to 4.30pm) or email xxx@xxx.xx (mailto:xxx@xxx.xx). See Clinical trials named contact (https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues#clinical-trials-named-contact) for further information.