NHS Trust clinical trial reporting systems and plans

The request was successful.

Dear Sir/Madam,

I am filing this freedom of information request on behalf of TranspariMED.

Evidence recently submitted to parliament indicates that the university failed to upload any due clinical trial results onto the European trial registry EudraCT between February and October 2019:
http://data.parliament.uk/writtenevidenc...

Q1. Has the university put into place policies, systems and processes that ensure that in future, every clinical trial sponsored by the university will post its summary results on every WHO primary trial registry (including Clinicaltrials.gov and ISRCTN) where it was originally registered within 12 months of trial completion? If yes, please state the month and year in which these were put into place. If no, if applicable, please state the month and year by which these are expected to be in place.

Q2. Has the university conducted a registry-data based audit of all clinical trials it has sponsored in the past that are listed on trial registries, including all interventional clinical trials listed on the registries EudraCT, ISRCTN, and Clinicaltrials.gov, to identify those trials that have never reported their results (i.e. neither on a registry nor on in a peer-reviewed academic journal)? If yes, please state the month and year in which the audit was completed. If no, if applicable, please state the month and year by which such an audit is expected to be completed.

Q3. Has the university developed a plan for retrospectively reporting the results of past trials that have remained unreported (i.e. reported neither on a registry nor on in a peer-reviewed academic journal)? If yes, please state the month and year the plan was adopted, and the month and year by which the process of retrospective results posting is expected to be completed. If no, if applicable, please the state the month and year by which such a plan is expected to be adopted.

Q4. By when does the university plan to have uploaded all due clinical trial results onto EudraCT?

Definitions:

For the purpose of this FOI request, a clinical trial is defined as per the WHO definition:
“[A] clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.”

Note:

A summary of the recent parliamentary session on clinical trial transparency, and a collection of useful tools for trial sponsors, can be found on the TranspariMED website.

Thank you for your time, best wishes,

Till Bruckner

Freedom of Information,



Please consider this e-mail as acknowledgement of your FOI request. We aim
to respond to your request within 20 working days.

 

Kind regards

 

The FOI Team

 

Have you searched the GMMH FOI disclosure log at
[1]https://www.gmmh.nhs.uk/disclosure-log? GMMH publishes responses to
previous FOI requests on our website and therefore information relating to
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Greater Manchester Mental Health NHS Foundation Trust

References

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Freedom of Information,

Dear Till,

Your questions refer to universities, however GMMH is an NHS Trust and therefore we are unable to answer the questions below. Please clarify whether your request refers to GMMH as an NHS Trust?

Kind regards

FOI Team

show quoted sections

Dear Freedom of Information,

this FOI was indeed directed at Greater Manchester Mental Health NHS Foundation Trust, but accidentally used the term "university" instead of "Trust". Please proceed with responding to this FOI request.

FYI: The Trust was listed in the table titled "NHS Trust and university sponsors that remained at 0% reported on the EUTrialsTracker" here:
http://data.parliament.uk/writtenevidenc...

Also:
http://eu.trialstracker.net/sponsor/grea...

Yours sincerely,

Till Bruckner

Freedom of Information,

1 Attachment

Dear Till,

 

Please find attached the response to your FOI request.  We would be
grateful if you would complete and return the below satisfaction survey.

 

Kind regards

 

The FOI Team

 

 

Please E-mail the electronic version to:

[1][email address]

 

 

1.            How do you rate the quality of service provided

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2.            How do you rate the degree to which the response answered
your request

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4.            How do you rate the overall helpfulness of replies

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5.            If any of the information was withheld, were you told which
exemptions had been applied to the information?

o Yes
o No
o Not applicable

6.            Did you receive the information within the 20 working day
deadline?

(if yes, please go to question 10)

o Yes
o No

7.            If you did not receive the information within the 20-day
deadline, were you advised about the delay and kept informed about the
progress?

o Yes
o No

8.            Did you look at the Publication Scheme on the Website to try
to find the information?

o Yes
o No

9.            If yes, how would you rate the ease of locating the
information?

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10.          Please give any further comments you would like to make

 

 

 

 

 

 

 

               

Thank you

 

 

 

 

show quoted sections

Dear Freedom of Information,

1. How do you rate the quality of service provided

o Very Good

2. How do you rate the degree to which the response answered
your request

o Very Good

3. How do you rate the ease of understanding of the response

o Very Good

4. How do you rate the overall helpfulness of replies

o Very Good

5. If any of the information was withheld, were you told which
exemptions had been applied to the information?

o Not applicable

6. Did you receive the information within the 20 working day
deadline?

o Yes

10. Please give any further comments you would like to make

Your team noted challenges with reporting on EudraCT. This may be useful to them, please pass the link on:
https://www.transparimed.org/single-post...

Yours sincerely,

Till Bruckner

Freedom of Information,



Please consider this e-mail as acknowledgement of your FOI request. We aim
to respond to your request within 20 working days.

 

Kind regards

 

The FOI Team

 

Have you searched the GMMH FOI disclosure log at
[1]https://www.gmmh.nhs.uk/disclosure-log? GMMH publishes responses to
previous FOI requests on our website and therefore information relating to
your query may already be available.

 

 

 

The information contained in this message and any attachments is intended only for the use of the individual
or entity to which it is addressed, and may contain information that is PRIVILEGED, CONFIDENTIAL and exempt
from disclosure under applicable law.
If you have received this message in error, you are prohibited from copying, distributing, or using the information.
Please contact the sender immediately by return e-mail and delete the original message from your system.
Remember that emails sent or received by our staff may be subject to disclosure under the Freedom of Information Act.

Greater Manchester Mental Health NHS Foundation Trust

References

Visible links
1. https://www.gmmh.nhs.uk/disclosure-log