Research completion
Steps to follow when completing a clinical trial or clinical research study
In line with the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, the University requires that all essential documents be retained for at least five years after the completion of clinical research, or for a longer period if there are other applicable requirements (eg clinical trials leading to a marketed product, or genetic studies).
If the study involves minors, essential documents should be archived until the youngest subject reaches 21, or five years after the conclusion of the study, whichever is longer.
The publication policy should be addressed in the protocol, a written agreement or a departmental SOP.
The chief investigator must provide a summary of the clinical research within one year of research completion to the MHRA (if a CTIMP/device trial), REC, the Research Governance, Ethics & Assurance Team and relevant NHS trust (if applicable).
The University is occasionally called upon to provide reference to recent publications. Please inform the Research Governance, Ethics & Assurance Team of the reference when your paper is accepted for publication.
It is mandatory for any interventional trial registered in European Union Drug Regulating Authorities Clinical Trials (EudraCT) database to enter results onto the EudraCT database.
| Timing of trial | Mandatory | Optional | Timing to post results |
|---|---|---|---|
| Ends on or after 21 July 2014 | Full data set | Summary attachment(s) | Up to one year after the trial ends. If affected by the system being offline the deadline is now 13 July 2016. |
| Ended less than one year prior to 21 July 2014 (ie trials that ended between 22 July 2013 and 21 July 2014) |
Full data set | Summary attachment(s) | Up to 21 July 2015. If affected by the system being offline the deadline is now 13 July 2016. |
| Ended more than one year prior to 21 July 2014 (ie trials that ended before 21 July 2013) |
Only one of the following:
|
Previously up to 21 July 2016. Deadline now extended to 21 December 2016. |
In order to enter data onto the EudraCT results database the results user must already be registered on EudraCT. Instructions to do this can be found on the EudraCT website.
Then there are two options on how to be assigned a trial within the database:
- Automatically assigned by selecting 'request assignment based on protocol information' if the user requesting assignment had their email address included in the original Clinical Trial Agreement (CTA) submitted to the national competent authority. The user will be automatically granted access as a results user if the email address matches their record.
- Alternatively the sponsor must sign a letter which is then uploaded by the user to EudraCT nominating the results user for that trial.
DOWNLOAD TEMPLATE NOMINATION LETTER
The nominated results user and a list of University of Oxford sponsored clinical trials to which you wish this user to be assigned should be sent to RGEA.Sponsor@admin.ox.ac.uk for processing. Once the letter is processed by EudraCT (this may take up to 25 days) the results user will be assigned the trial and can give other users access.
Further information about uploading the results can be found in the EudraCT website's help and FAQ sections.
