Clinical trial transparency (for UAEM Global Health Ranking)

Till Bruckner made this Freedom of Information request to University of Liverpool This request has been closed to new correspondence. Contact us if you think it should be reopened.

The request was successful.

Till Bruckner
Delivered

Dear University of Liverpool,

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

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foi Uof Liverpool, University of Liverpool

Dear Mr Bruckner,

Thank you for your email requesting information about clinical trial policies and audit. I am writing to acknowledge your request and to advise that we will deal with it as soon as possible. We will respond within 20 working days and by 26 July 2018.
Your sincerely,

Vicki Heath

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foi Uof Liverpool, University of Liverpool

4 Attachments

 

[1]Mrs Lesley Jackson Freedom of Information Co-ordinator The Foundation
Building 765 Brownlow Hill Liverpool L69 7ZX F 0151 794 3272 E
[University of Liverpool request email] www.liverpool.ac.uk

 

FOI/LJ

 

27^th July 2018

 

 

Mr Till Bruckner

Via email:  [2][FOI #494714 email]

 

 

Dear Mr Bruckner,

 

Thank you for your email received 30^th June 2018 requesting information
concerning clinical trial transparency for UAEM Global Health Ranking.  I
am pleased to provide the requested information as set out below and
attached:-

 

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?

 

Not detailed in an SOP but we ensure this as part of the Sponsor
Permission to Proceed process – detailed in SOP004 attached

 

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?

 

Detailed in SOP02 - attached

 

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.

 

Not from a Sponsor perspective

 

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.

 

Not from a Sponsor perspective

 

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?

 

Not from a Sponsor perspective

  

If you are not satisfied with the University’s response to your request,
you may ask the University to review it.  If you wish to do this, please
write to the Freedom of Information Reviewer, Legal, Risk & Compliance,
The University of Liverpool, The Foundation Building, 765 Brownlow Hill,
Liverpool, L69 7ZX (email [3][University of Liverpool request email]), enclosing a copy of
your original request and explaining your complaint.  Please include an
address for correspondence.

 

If you remain dissatisfied with the handling of your request, you have a
right to appeal to the Information Commissioner at:-

 

The Information Commissioner’s Office, Wycliffe House, Water Lane,
Wilmslow, Cheshire, SK9 5AF.

Telephone:      0303 123 1113

Website: [4]www.ico.org.uk  

 

Yours sincerely,

Lesley Jackson

Freedom of Information Co-ordinator

 

 

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