Amendment and study progress

For all non-EU Clinical Trials of Investigational Medicinal Products (Non-CTIMPs)

 

Amendments

All amendments, both substantial and minor, made during the life of the study must be notified promptly to the R&D Department.  You should submit to R&D all the documentation that is sent to the Ethics Committee at the same time to ensure there is no delay with R&D approval/acknowledgement.

Guidance on amendments and the relevant forms for submission can be found on the NRES website here:

 

> Amendments

Annual Progress Reports (APRs)

A progress report should be submitted to the Ethics Committee 12 months after the date on which the favourable opinion was given.  A copy must also be submitted to R&D at the same time.  We rely on the information provided in the report to ensure that we are reporting to relevant bodies up to date and accurate data relating to individual studies.

The APR form that should be completed can be found here:

 

> Annual Progress Reports

Failure to submit the report to the ethics committee can potentially nullify the favourable opinion received – please ensure that these reports are submitted.

 

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End of study notification

Please ensure you tell us when your study has finished by completing the end of study form found at here:

 

> End of study and final report

 

 

EU Clinical Trials of Investigational Medicinal Products (CTIMPs)

All guidance above applies to studies that fall under the EU Directive, however there are some additional points to remember:

 

 

Annual Safety Reports (ASRs)

An Annual Safety Report must be submitted to the Ethics Committee, MHRA and the R&D Department annually on the anniversary of the Clinical Authorisation Approval (CTA). 

 

Guidance on the content of the ASR can be found on the MHRA website:

> MHRA: ASRs

 

ASRs submitted to the Ethics Committee need to accompany the CTIMP Safety Report for Main REC form which can be found on the NRES website:

> Safety reports for CTIMPs

 

 

End of study notification

 

You must ensure you tell us in a timely manner when your study has finished.  If your study completed as per the End of Study definition in your protocol, you should submit the end of study notification form to Ethics, R&D and MHRA within 90 days (calendar days) of the study end date.

If your study terminates early for any reason, you must submit the end of study notification form to Ethics, R&D & MHRA within 15 days of the study end date.

The end of study notification form can be found at on the NRES website:
> End of study notification

 

Remember to submit your Final Research Report to the Ethics, R&D & MHRA within 12 months of your end of study notification.

 

 

Please note:

 

For end of study and amendments, CTIMPs have their own form.  Please ensure you complete the correct form when submitting to the relevant bodies.

Where applicable, amendments must also be sent to the MHRA for CTIMPs.  Additional guidance can be found on the MHRA website or by contacting the Clinical Trials Office.

 

 

 

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