Mr Till Bruckner

By email only to: request-494718-a09228be@whatdotheyknow.com

URL: https://www.whatdotheyknow.com/request/clinical_trial_transparency_for_21

27 July 2018

Dear Mr Bruckner,

Freedom of Information Act 2000

Request for information: response
Date of request: 28 June 2018
Due date: 26 July 2018
Ref: RITM0112870

We refer to your request for information dated 28 June 2018. Please accept our apologies for the delay in
responding to your request.

We confirm that the University holds information of the description specified in your request. The answers
to your questions are as follows—

1. Question

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?

2. Response

For Q1 and 2: Yes, we have publicly available research policies available here
https://www.southampton.ac.uk/about/governance/regulations-policies-
guidelines.page#research_%26amp%3B_enterprise_policies
Mr Till Bruckner —2— 27 July 2018

In particular the University has a Research Data Management Policy, Open Access Policy, an Ethics Policy
and the University’s Code of Conduct for research clearly states that all researchers are obliged to be aware
of and comply with all requirements relevant to their particular research.

Q3. No such audit has been undertaken nor planned to be undertaken at the current time.

Q4. No we don’t have such plans. However the University has oversight of monitoring activities for CTIMPs
it sponsors and seeks to ensure studies are carried out in compliance with the ICH Good Clinical Practices
and our funder requirements.

Q5. No as these are quite specific examples of potential misconduct. Our Code of Conduct (which can be
found from link above) emphasises good research conduct and needs to be applicable to researchers from
all disciplines not just those undertaking medical research. The principles of excellence, openness, integrity
and rigour outlined in the Code is applicable. In addition, such activity deemed as research misconduct,
would be handled according to the University’s Procedures for investigating cases of alleged misconduct in
research, which is publically available.

If you do not feel that we have dealt with your request in accordance with the requirements of Part I of the
Act, you may request a review. Your request for a review should specify in what respect you consider that
the requirements of Part I have not been met. The request for a review should be addressed to the Chief
Operating Officer and may be sent by email to foi@soton.ac.uk.

The Information Commissioner is responsible for enforcing rights of access to information and the operation
of the publication scheme. You may apply to the Information Commissioner in writing (FOI/EIR Complaints
Resolution, Information Commissioner's Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF)
or electronically for a decision whether, in any specified respect, your request for information has been
dealt with by the University in accordance with the requirements of Part I of the Act. The Information
Commissioner will not normally take action unless she is satisfied that the University's review procedures
have been exhausted.

Yours sincerely,

Freedom of Information Office

email: foi@soton.ac.uk
Mr Till Bruckner —3— 27 July 2018