Clinical trial transparency (for UAEM Global Health Ranking)

Roedd y cais yn llwyddiannus.

Dear University of Leeds,

Q1. Does the university have publicly available policies and/or SOPs that require its staff to follow global best practices in clinical trial registration and registry entry maintenance?

Q2. Does the university have publicly available policies and/or SOPs that commit it to following global best practices in clinical trial summary results posting?

Q3. Has the university within the last 12 months made public an internal audit of trial registration and/or summary results posting performance? If yes, please share a link to that document.

Q4. Does the university have time-specific plans to retrospectively post missing summary results for university-sponsored clinical trials completed in the past? If yes, please share a link to that document. If the document is not online, please provide a copy of the document.

Q5. Does the university have a publicly available policy that prohibits its staff from undeclared ‘outcome switching’, HARKing, p-hacking and/or similar (mal)practices when they report clinical trial outcomes?

This FOI request is being filed on behalf of UAEM-UK and TranspariMED.

Please note that the answers to these questions will be used to determine the university’s score in the forthcoming Global Health Ranking of leading UK universities by Universities Allied for Essential Medicines (UAEM) UK.

We encourage you to read this background briefing before compiling your response:
https://www.scribd.com/document/38281405...

Thank you very much for your time, best wishes,

Till Bruckner / TranspariMED

Tracey Crombie,

I am out of the office until Monday 2 July and I will respond to any emails on my return. I apologise for any inconvenience this may cause. If your query is urgent, please contact Helen Pickersgill on 0113 34 34036 or [email address].

Jenny Foggin,

I am away from the office and will not return until Tuesday 3 July. If your email is about a Freedom of Information request, please contact Tracey Crombie in the Legal Adviser's Office. If it is otherwise urgent, please contact the Secretariat for advice on 343 4036.

Tracey Crombie,

Dear Till

I can confirm receipt of the request below, dated 28 June 2018. 

Your request is being dealt with under the terms of the Freedom of Information Act 2000 and will be answered within twenty working days.  As such, you should expect to hear from the University in response by 26 July 2018, if, in the meantime, you have any queries about the request, please don’t hesitate to contact Jenny Foggin ([email address]).   

Kind regards

Tracey Crombie
PA to the Legal Adviser
University of Leeds
LS2 9JT
Tel:  0113 343 4078 (NB 8am-4pm)
Fax:  0113 343 3925

This communication is intended solely for the addressee, is strictly confidential and may also be legally privileged.  If you are not the addressee please do not read, print, re-transmit, store or act in reliance on it or any attachments.  Instead, please contact Tracey Crombie on the above telephone number.

Any liability (in negligence or otherwise) arising from any third party acting, or refraining from acting, on any information contained in this email is excluded.

It is the responsibility of the receiver of this email to ensure that any onward transmission or use of this email (including attachments) will not adversely affect their systems or data contained on their systems.  Receivers are advised to carry out virus checks.  The University of Leeds accepts no responsibility with regard to the communication or other use of this email.

dangos adrannau a ddyfynnir

Jenny Foggin,

Dear Mr Bruckner,

 

I have set out below responses to the questions that you raised in your
email of 28 June.

 

I hope this is helpful in resolving your query. If you have any questions
about this email, however, please don't hesitate to contact me.

 

If you are unhappy with the service you have received in relation to your
request and wish to make a complaint or request a review of our decision,
you should write to or email directly Mr D Wardle, Deputy Secretary, The
University of Leeds, Leeds, LS2 9JT ([email address]). You should
do so within three months of receiving the University’s response to your
request. Further information about how the University manages Freedom of
Information requests and about our complaints procedure is also available
on our website (www.leeds.ac.uk).

 

If you are not content with the outcome of the internal review, you have
the right to apply directly to the Information Commissioner for a
decision.  Generally, the ICO cannot make a decision unless you have
exhausted the review/complaints procedure provided by the University.  The
Information Commissioner can be contacted at:  Information Commissioner’s
Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.

 

Best wishes,

 

Jenny

 

Jenny Foggin

Senior Governance and Freedom of Information Officer

Legal Adviser’s Office

The University of Leeds

0113 3431155

 

 

 

 

 

dangos adrannau a ddyfynnir

Dear Jenny,

I cannot find the response in your reply on this platform:
https://www.whatdotheyknow.com/request/4...

I also cannot find it in my email inbox.

Can you please resend it via WhatDoTheyKnow so that it becomes publicly visible?

(I assume you may have forgetten to attached the official response letter when you originally replied.)

Thank you in advance, best wishes,

Till

Jenny Foggin,

1 Atodiad

  • Attachment

    Re FW Freedom of Information request Clinical trial transparency for UAEM Global Health Ranking.txt

    2K Download View as HTML

Dear Mr Bruckner,

 

I am sorry that you were not able to see my responses in this email of 18
July. I am resending it in the hope that this clears matters up.

 

Best wishes,

Jenny

 

 

*********************************************************************

Jenny Foggin

Senior Governance and Freedom of Information Officer

Secretariat

University of Leeds

 

(0113) 343 1155

*********************************************************************

 

 

 

 

 

From: Jenny Foggin
Sent: 18 July 2018 13:03
To: '[FOI #494716 email]'
<[FOI #494716 email]>
Cc: Tracey Crombie <[email address]>
Subject: FW: Freedom of Information request - Clinical trial transparency
(for UAEM Global Health Ranking)

 

Dear Mr Bruckner,

 

I have set out below responses to the questions that you raised in your
email of 28 June.

 

I hope this is helpful in resolving your query. If you have any questions
about this email, however, please don't hesitate to contact me.

 

If you are unhappy with the service you have received in relation to your
request and wish to make a complaint or request a review of our decision,
you should write to or email directly Mr D Wardle, Deputy Secretary, The
University of Leeds, Leeds, LS2 9JT ([1][email address]). You
should do so within three months of receiving the University’s response to
your request. Further information about how the University manages Freedom
of Information requests and about our complaints procedure is also
available on our website ([2]www.leeds.ac.uk).

 

If you are not content with the outcome of the internal review, you have
the right to apply directly to the Information Commissioner for a
decision.  Generally, the ICO cannot make a decision unless you have
exhausted the review/complaints procedure provided by the University.  The
Information Commissioner can be contacted at:  Information Commissioner’s
Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.

 

Best wishes,

 

Jenny

 

Jenny Foggin

Senior Governance and Freedom of Information Officer

Legal Adviser’s Office

The University of Leeds

0113 3431155

 

 

 

 

 

dangos adrannau a ddyfynnir

Dear Jenny Foggin,

I am still unable to see / access the information via this link:
https://www.whatdotheyknow.com/request/c...

This is unusual - we haven't had that problem with other FOI responses.

You could try to copy the original reply into the body of your message so that we can access it.

Yours sincerely,

Till Bruckner

Jenny Foggin,

Dear Mr Bruckner,

I wonder if it is because the text of my reply is in a different colour? I tend to do that, to make it easier to distinguish reply from question. I can't understand why that might cause an issue, but I really can't think of another reason. I have copied it again below, all in black.

Best wishes,

Jenny
Q1. Does the university have publicly available policies and/or SOPs that require its staff to follow global best practices in clinical trial registration and registry entry maintenance? We work in line with HRA/MHRA processes which mandate this - we therefore follow the publically available HRA policies

Q2. Does the university have publicly available policies and/or SOPs that commit it to following global best practices in clinical trial summary results posting? We follow the HRA guidance and their publically available policies

Q3. Has the university within the last 12 months made public an internal audit of trial registration and/or summary results posting performance? If yes, please share a link to that document. The University has not done this.

Q4. Does the university have time-specific plans to retrospectively post missing summary results for university-sponsored clinical trials completed in the past? If yes, please share a link to that document. If the document is not online, please provide a copy of the document. There is no information held regarding such time-specific plans.

Q5. Does the university have a publicly available policy that prohibits its staff from undeclared ‘outcome switching’, HARKing, p-hacking and/or similar (mal)practices when they report clinical trial outcomes? The University has a policy on research misconduct which is available.

This FOI request is being filed on behalf of UAEM-UK and TranspariMED.

Please note that the answers to these questions will be used to determine the university’s score in the forthcoming Global Health Ranking of leading UK universities by Universities Allied for Essential Medicines (UAEM) UK.

We encourage you to read this background briefing before compiling your response:
https://www.scribd.com/document/38281405...

Thank you very much for your time, best wishes,

Till Bruckner / TranspariMED

*********************************************************************
Jenny Foggin
Senior Governance and Freedom of Information Officer
Secretariat
University of Leeds

(0113) 343 1155
*********************************************************************

dangos adrannau a ddyfynnir

Dear Jenny Foggin,

thank you, this is visible / accessible now.

Yours sincerely,

Till Bruckner