Cinical trial audit and action plan

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

This request has been closed to new correspondence. Contact us if you think it should be reopened.

The request was successful.

Dear University of Aberdeen,

could you please provide:

1. A copy of the audit report produced as a result of the clinical trial audit conducted on behalf of the University by the NHS in July 2017

2. A copy of the action plan the university drew up in response to the audit

3. Copies of any updates of the action plan, and/or progress reports on the action plan.

Thank you very much.

Yours faithfully,

Till Bruckner

Foi, University of Aberdeen

Dear Mr Bruckner

I refer to your email of 23 March 2018 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 the Act, a reply will be sent to you within 20 working days.

Yours sincerely,
Lorna Maguire

University Records Manager
Library, Special Collections & Museums
The Sir Duncan Rice Library
The University of Aberdeen
Bedford Road
Aberdeen
AB24 3AA

T: 01224- 273175
Email: [email address]

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Foi, University of Aberdeen

1 Attachment

Dear Mr Bruckner

 

FREEDOM OF INFORMATION REQUEST FOI 2018-116

 

I refer to your email of 23 March 2018 requesting information relating to
a clinical trial audit and action plan, conducted on behalf of the
University by the NHS in July 2017.

 

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

 

 

1.    A copy of the audit report produced as a result of the clinical
trial audit conducted on behalf of the University by the NHS in July 2017.

 

        A copy of the audit report has been provided in the attached
document ( IQA-43 Publication process.pdf).

 

2.    A copy of the action plan the university drew up in response to the
audit.

     

       This forms part of the audit – please refer to the attached
document.

 

3.  Copies of any updates of the action plan, and/or progress reports on
the action plan.

 

i)             The Risk Assessment for Sponsorship includes a specific
section on Registration of Protocol and Dissemination of results: Sponsor
Risk Assessment, with proof of  Completed  

                Registration required by the Sponsor.

 

ii)            The posting of results on eudract is now a Formal Delegated
Task on the co-sponsorship agreement.

 

iii)           The Study Initiation Visit, carried out by monitors, now
includes a requirement for them to confirm that the protocol been
registered on a Public Database.

 

iv)           The study close out Monitoring Visit, conducted also by
monitors, now tasks them to confirm that a) all registers been updated b)
the letter of authorization to eudract was issued

                and c) that work results have been entered or is in
progress

 

It has not proven currently possible to provide a link to the Publication
on eudract, as detailed in the audit, due to the setup of the website.
Work is ongoing to upload results. Where the study was conducted through
our local Clinical Trials Unit, the uploading of results for one study has
been completed, a second is 95% complete, and the results of a third study
has started. Analysis for two of the projects is still ongoing and once
completed, staff will prioritize upload of the results.

 

 

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, [1][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,
you have the right to appeal to the Scottish Information Commissioner
within six months of the date of receipt of the University’s review
notice. Details on how to make an appeal to the Commissioner are 
available at [2]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,

 

Lorna Maguire

University Records Manager

Library, Special Collections & Museums

The Sir Duncan Rice Library

The University of Aberdeen

Bedford Road

Aberdeen

AB24 3AA

 

Email: [3][University of Aberdeen request email]

 

 

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Dear Foi,

thank you very much, your speedy response is appreciated.

Yours sincerely,

Till Bruckner