Good morning Till,

I am writing to acknowledge your request under the Freedom of Information Act 2000 received by The University of Manchester on 29 June 2018, our reference as per the subject line.

The University will respond to your request within 20 working days.

Kind regards

Sharon

Sharon Glen | Information Officer | Information Governance Office | Directorate of Compliance and Risk |Professional Support Services | G6 Christie Building | The University of Manchester | Oxford Road | Manchester | M13 9PL | Tel +44(0) 161 306 7549| www.manchester.ac.uk

We are all responsible for protecting personal data held by the University, including who we share that data with. Stop and think before you send your email.  For further guidance see: www.dataprotection.manchester.ac.uk

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Dear Till,

Thank you for your request for information received by The University of
Manchester on 29 June 2018 which was 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?

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?

The University has now considered your request and our response can be
found below.

1.       For all drug trials that go through Clinical Trials Management
Group (CTMG), Eudract registration is required and is listed in the
following Standard Operating Procedures which can be found at
[1]http://www.staffnet.manchester.ac.uk/ser...

UM/UoM Sponsorship of Study/SOP03/4.0

UM/UoM Clinical Trial Authorisation/SOP07/6.0

For all non-drug trials that go through CTMG, there is a requirement to
register all clinical trials on a public database – in line with UK best
practice

UM/UoM Sponsorship of Study/SOP03/4.0

2.       In the area for trials there is no SOP or policy, but the posting
of data is in line with the University of Manchester Data Management Plan
(DMP) and regulatory requirements.

3.       No information held - In the area of clinical trials there has
been no internal audit of trial registrations and/or summary results
posting performance.

4.       No information held - In the area of clinical trials there is no
such plan to do so in the near future.

5.       No information held - In the area of clinical trials there is no
such policy.

I trust this information is of use to you.

Kind regards

Sharon

Sharon Glen | Information Officer | Information Governance Office |
Directorate of Compliance and Risk |Professional Support Services | G6
Christie Building | The University of Manchester | Oxford Road |
Manchester | M13 9PL | Tel +44(0) 161 306 7549| [2]www.manchester.ac.uk

[3]data_matters_logo2-(3)

We are all responsible for protecting personal data held by the
University, including who we share that data with. Stop and think before
you send your email.  For further guidance see:
[4]www.dataprotection.manchester.ac.uk

Confidentiality and Legal Privilege: The contents of this email and its
attachment(s) are confidential to the intended recipient and may be
legally privileged. It may not be disclosed, copied, forwarded, used or
relied upon by any person other than the intended addressee. If you
believe that you have received the email and its attachment(s) in error,
you must not take any action based on them, nor must you copy or show them
to anyone. Please respond to the sender and delete this email and its
attachment(s) from your system.

References

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