2nd July 2018

Dear Till,

I write to acknowledge receipt of your request, dated 28th June 2018, made under the provisions of the Freedom of Information Act 2000.

Please note the effective date of the request, i.e. date of receipt of your request by the University of Leicester for processing, is 28th June 2018 and that the latest date by which the University must respond under the terms of the Freedom of Information Act 2000 is 27th July 2018.

I will arrange for the information to which you are entitled under the Freedom of Information Act 2000 to be supplied to you as soon as reasonably possible, and in any event within the period set out by the Act.

Please do not hesitate to contact me if you have any queries regarding your request.

Regards,

Claudia Perdomo-Pelaez
Senior Information Assurance Officer
Information Assurance Services,
University of Leicester, University Road, Leicester, LE1 7RH, UK
t: +44 (0)116 229 7345
e:  [email address] 
w: www.le.ac.uk

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18th July 2018

Dear Till,

I write on behalf of the University of Leicester in response to your request, dated 28th June 2018 made under the provisions of the Freedom of Information Act 2000. Our response is as follows

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?

Yes, please refer to our good practice in research website.
https://www2.le.ac.uk/offices/researchsu...

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?

Yes, please refer to website referred above.

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.

No. The University does not have information recorded regarding this question.

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.

No. The University does not have information recorded regarding this question.

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 publicly available policy called Research Code of Conduct, which section 6 provides for research misconduct. Please refer to following link
https://www2.le.ac.uk/offices/researchsu...

If you have any concerns or wish to complain or appeal about any aspect of this response then in the first instance please contact the University's Data Protection Officer (Mr Parmjit Gill: 0116 229 7946, [email address])

Please be aware that it is also your legal right under Section 50 of the Freedom of Information Act, to apply to the Information Commissioner for a decision whether a request for information made to the University has been dealt with in accordance with the provisions of the Act. It should be noted that there is a requirement that there will be no undue delay in making the application and there is an expectation that the complainant will have exhausted the University's internal complaints procedure.

Complaints to the Information Commissioner should be addressed to:

FoI Compliance Team (Complaints)
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

I hope you find this response helpful. Please don't hesitate to contact me if you have any queries regarding the above.

Regards,

Claudia Perdomo-Pelaez
Senior Information Assurance Officer
Information Assurance Services,
University of Leicester, University Road, Leicester, LE1 7RH, UK
t: +44 (0)116 229 7345
e:  [email address] 
w: www.le.ac.uk

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