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End of Trial

The following section will provide guidance on end of trial notification and Trial Close Down processes for Clinical Trials which are sponsored by Cardiff University.

 

 Definition of the End of the Trial

The definition of the end of the trial should be provided in the protocol and any change to this definition should be notified to the MHRA and Research Ethics Committee (REC) as a substantial amendment. In most cases, it will be the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol.

Final analysis of the data (following ‘lock’ of the study database) and report writing is normally considered to occur after formal declaration of the end of the trial.

 1. Notify MHRA and Research Ethics Committee

The EUDRA CT Declaration of the End of Trial form should be sent to the MHRA and the relevant REC within 90 days of the end of the trial, or within 15 days if the project is terminated early.
Where the project is terminated early, or halted temporarily, reasons should be given.  The MHRA will acknowledge receipt of the End of Trial Declaration.

End of trial declarations to the MHRA for clinical trials that were originally CTX/DDX applications
For trials that were originally Clinical Trial Exemption (CTX) and Doctor and Dentist Exemption (DDX) studies, you should fill out the CT Form UK and submit, with a completed Notification of Amendment form or Declaration of the End of a Clinical Trial form.

For further guidance on end of trial processes required by MHRA please click here. For further guidance on end of trial processes required by the National Research Ethics Services (NRES) please click here.

Reports within one year of trial end
A summary of the End of Trial Study Report should be sent to the MHRA and relevant Ethics Committee within 12 months of the end of the trial. The summary of the final report may be enclosed with the end of study declaration, or sent to the MHRA and relevant ethics committee subsequently.

There is no standard format for final reports. As a minimum, information should be provided on whether the project achieved its objectives, the main findings and arrangements for publication or dissemination of the research, including any feedback to participants.

All correspondence with the MHRA and NRES should be retained in the Trial Master File and copied to the Sponsor.

 2. Notify Sponsor

Once the MHRA and the REC have been informed of the end of the trial, please notify the Research Governance Team.

Sponsor Close Down Visit
Once notified of the end of trial, the Research Governance Team will arrange a Trial Close Down Visit . At the Close Down Visit, the Sponsor will review the Trial Master File (TMF) using the and review the subject file to ensure files are complete and contain all essential trial documentation. Following the Close Down Visit, the Sponsor will produce a report and if necessary, provide a list of actions that will need to be satisfied before the Sponsor can issue a ‘Trial Close Down’ letter. Normally, a copy of the final locked database should be provided to the Sponsor before the Trial Close Down letter can be issued.

The process for the Trial Close Down Visit (for Clinical Trials sponsored by Cardiff University) is described by a Sponsor Close Down Visit SOP. For further information on the Close Down Visit please contact the Research Governance Team.

 3. Notify host organisation (R&D)

For single centre trials: CI to notify the local R&D office that the trial has ended. Notification requirements will be determined by the local R&D office.
For multi-centre trials:
Ensure that all local PIs are notified that the trial has ended. It may be more appropriate for the local PI to notify local R&D office.

 4. Data Verification / Source Data Verification

This process aims to ensure the most accurate validated set of data is provided for statistical analysis. Please refer to the CU for further information.

 5. Database Lock

The CI is required to provide the Sponsor with a copy of the locked trial database (where applicable) following study recruitment / follow up. The final database must be "locked" to ensure access to the final data set is permanently restricted for final analysis and report, prior to archiving. Please refer to the CU for further information.

 6. Data Analysis

It is important that the final analysis is carried out promptly after the appropriate follow-up period & involves a qualified statistician. The analysis should follow a carefully written analysis plan which should be written prior to unblinding of data. All outcome measures stated in the protocol should be fully analysed. The analysis should then be discussed by the Trial Management Group and Data Monitoring Committee/Trial Steering Committee where appropriate, to assist interpretation and to discuss the implications of the findings.  

The following EMA documents are essential reading : E3 - Structure and Content of Clinical Study Reports, E9 - Statistical Principles for Clinical Trials & CFPMP - Committee for Proprietary Medicinal Products.

 7. Dissemination of results

Results of the clinical trial should be disseminated, not only to the research community, but also to the general public. It is recommended that the CONSORT guidelines are followed when preparing a manuscript for a clinical trial. This ensures that all relevant information about the trial is reported in the publication.

  8. Archiving

Essential documents must be retained (archived) for sufficient periods to allow for audit and inspection by regulatory authorities and should be readily available upon request. For further information, please refer to the Cardiff University’s Governance and Compliance Division can provide further information on archiving and record management.

 9. End of Trial Checklist

1

MHRA and Ethics

Inform MHRA and REC of Trial Close Down using the Declaration of the End of Trial form 

 

End of Trial Study Reports

Within 12 months, provide MHRA and relevant ethics committee with end of trial study report.

2

Sponsor (Close Down Visit)

-Once you have contacted MHRA and Ethics contact the Research Governance Team who will set up a ‘Close Down Visit'.

-Ensure that the TMF is complete using the

- Following a satisfactory Close Down Visit you will be issued with a Sponsor 'Trial Close Down’ letter.

3

R&D Host

Inform Host R&D that trial has ended.

4Data Verification / Source Data VerificationRefer to the Data Management SOP
5Database LockProvide Sponsor with a copy of the locked trial database (where applicable). Refer to the for more information.

6

Data Analysis

Carry out the final analysis and discuss with Trial Management Group and Data Monitoring Committee/ Trial Steering Committee where appropriate.

7

Dissemination of Results

It is recommended that the CONSORT guidelines are followed when preparing a manuscript for a clinical trial.

8

Archiving

Refer to the Cardiff University’s Governance and Compliance Division provide further information on archiving and record management.