Clinical trials registration and reporting

Till Bruckner made this Freedom of Information request to University of Aberdeen

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was successful.

Dear Sir/Madam,

Could you please provide the following information:

1. Does the university have a policy requiring those conducting clinical trials in humans to register those trials on a public clinical trials registry before the first participants are recruited? If yes, please provide a link to the policy.

2. Does the university have a policy requiring those conducting clinical trials in humans to post the results of those trials on a public clinical trials registry within 12 months of a trial being completed? If yes, please provide a link to the policy.

3. Does the university have a policy requiring those conducting clinical trials in humans to post the methodologies of those trials on a public clinical trials registry and/or different online platforms, and if so, within what time frame? If yes, please state the time frame and provide a link to the policy.

4. Does the university audit staff and contractor compliance with the policies referred to in questions 1-3? If yes, please provide a link to a document providing the most recent audit data, or if such data exist but are not online, please provide the relevant data.

5. How many clinical trials sponsored by the university were completed during the calendar year 2015?

6. How many clinical trials sponsored by the university that were completed during the calendar year 2015 have been registered on a public clinical trials registry as of today?

7. How many clinical trials sponsored by the university that were completed during the calendar year 2015 have posted results on a public clinical trials registry as of today?

8. Please provide the name of each clinical trial that was sponsored by the university and was completed during the calendar year 2015 that has not been registered on a public clinical trials registry as of today, together with the name and email address of the Principal Investigator (or equivalent position within the research team) of that trial.

9. Please provide the name and unique identification number of each clinical trial that was sponsored by the university and was completed during the calendar year 2015 that has not posted its results on a public clinical trials registry as of today, together with the name and email address of the Principal Investigator (or equivalent position within the research team) of that trial.

Thank you for your time, I look forward to hearing from you,

Till Bruckner

Foi, University of Aberdeen

Dear Mr Bruckner,

I refer to your email of 24th February 2017 and, on behalf of the University, I acknowledge receipt and confirm that your request is being dealt with in terms of the Freedom of Information (Scotland) Act 2002. In terms of that Act, a reply will be sent to you within 20 working days.

Yours sincerely,
Amy Walsh.

Amy Walsh
Administration Assistant.
Email: [email address] Tel: 01224 273079

Core working hours: Monday - Friday: 8.45am - 1.00pm
The Sir Duncan Rice Library, LSC&M, Aberdeen University, Bedford Road, Aberdeen AB24 3AA

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Foi, University of Aberdeen

Dear Till Bruckner,

 

FREEDOM OF INFORMATION REQUEST FOI 2017-059

 

I refer to your email of 24 February 2017 requesting information relating
to clinical trials at the University of Aberdeen.

 

Your request has now been considered under the Freedom of Information
(Scotland) Act 2002, ‘the Act’.

 

1.            Does the university have a policy requiring those conducting
clinical trials in humans to register those trials on a public clinical
trials registry before the first participants are recruited? If yes,
please provide a link to the policy.

 

The University does not have a documented policy requiring clinical trials
involving humans sponsored by the University to be registered on a public
clinical trials registry, although it is routine practice to do so. Please
accept this message as a notice under section 17(1)(b) that the University
does not hold the information you have requested.

 

2.            Does the university have a policy requiring those conducting
clinical trials in humans to post the results of those trials on a public
clinical trials registry within 12 months of a trial being completed? If
yes, please provide a link to the policy.

 

The University’s policy on publication of results is outlined in Clinical
Research Governance standard operating procedure 33. The procedure can be
viewed on our website at,

[1]http://www.abdn.ac.uk/clinicalresearchgo...

 

3.            Does the university have a policy requiring those conducting
clinical trials in humans to post the methodologies of those trials on a
public clinical trials registry and/or different online platforms, and if
so, within what time frame? If yes, please state the time frame and
provide a link to the policy.

 

The University does not have a documented policy requiring publication of
the methodology used in clinical trials involving humans sponsored by the
University. Please accept this message as a notice under section 17(1)(b)
that the University does not hold the information you have requested.

 

4.            Does the university audit staff and contractor compliance
with the policies referred to in questions 1-3? If yes, please provide a
link to a document providing the most recent audit data, or if such data
exist but are not online, please provide the relevant data.

 

The University does not audit compliance with the requirement set out in
paragraph 5.6 of the procedure cited in answer to your second question.
Please accept this message as a notice under section 17(1)(b) that the
University does not hold the information you have requested.

 

5.            How many clinical trials sponsored by the university were
completed during the calendar year 2015?

 

One co-sponsored trial was completed in this period.

 

6.            How many clinical trials sponsored by the university that
were completed during the calendar year 2015 have been registered on a
public clinical trials registry as of today?

 

One trial had been registered by the date of your request.

 

7.            How many clinical trials sponsored by the university that
were completed during the calendar year 2015 have posted results on a
public clinical trials registry as of today?

 

One trial had posted results by the date of your request.

 

8.            Please provide the name of each clinical trial that was
sponsored by the university and was completed during the calendar year
2015 that has not been registered on a public clinical trials registry as
of today, together with the name and email address of the Principal
Investigator (or equivalent position within the research team) of that
trial.

 

No trials sponsored by the University fall into this category. Please
accept this message as a notice under section 17(1)(b) that the University
does not hold the information you have requested.

 

9.            Please provide the name and unique identification number of
each clinical trial that was sponsored by the university and was completed
during the calendar year 2015 that has not posted its results on a public
clinical trials registry as of today, together with the name and email
address of the Principal Investigator (or equivalent position within the
research team) of that trial.

 

No trials sponsored by the University fall into this category. Please
accept this message as a notice under section 17(1)(b) that the University
does not hold the information you have requested.

 

Should you be dissatisfied with this response, you have the right under
the Act, to request a review.  A request for review must be made within 40
working days of the date of this reply. It must include your name and
address for correspondence and specify the request for information and the
grounds for dissatisfaction with the decision. Please send your request
for review to our mailbox, [University of Aberdeen request email]. The University will respond to
your request for a review within 20 working days of receipt of your
request.

 

If you are unhappy with the outcome of the University’s internal review
process, you have the right to appeal to the Scottish Information
Commissioner, within 6 months from the date of receipt of the University’s
review notice. Details on how to make an appeal to the Commissioner are 
available at:  www.itspublicknowledge.info/Appeal. Should you remain
dissatisfied with the Commissioner’s decision, you have a right of appeal
to the Court of Session on a point of law.

 

Yours sincerely,

Iain Gray

 

University Data Protection Officer

University of Aberdeen

 

 

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Dear Iain Gray,

thank you very much for such a clear and comprehensive response.

Yours sincerely,

Till Bruckner