Details on Trials Transparency at Bangor University

The request was successful.

Dear Bangor University,

We are interested in how universities and hospital trusts manage the registration of clinical trials and the reporting of their summary results at the institutional level. For the avoidance of doubt, we are not interested in, nor asking about, trialists sharing of individual patient-level data with re-identification risks nor about specific study-level documentation. Throughout this request, we refer to clinical trials as defined by the WHO (i.e. not just CTIMPs as covered under EU law) (https://www.who.int/news-room/q-a-detail...).

1. Please can I request your clinical trials transparency/clinical trial registration and reporting policy or policies, standard operating procedures (SoPs), guidance given to staff, and any other overarching documentation for your institution related to the registration and reporting of clinical trials. If your institution contains sub-units (i.e. CTUs, joint research offices) with their own detailed clinical trials policies and procedures separate from any overarching institutional documentation, please provide these as well.

If you provide more than one document can you please indicate which document(s) primarily cover which of these areas and if possible the relevant sections of the document provided (or acknowledge the absence of documentation covering these areas):

-Requirements related to the registration of clinical trials.

-Requirements for investigators to report the summary results (non-individual patient-level results) of their clinical trials in any form.

-Requirements to report results, specifically, to a clinical trial registry for all clinical trials (e.g. EU Clinical Trial Register, ClinicalTrials.gov, ISRCTN or any other ICTRP approved registry).

-Processes for determining sponsorship of clinical trials, and how sponsorship responsibility is assumed/handed off when new primary investigators (PIs) join or leave the institution.

-If applicable, how responsibility for registration and reporting is handled for trials with external (domestic or international) collaborators.

-If applicable, how registration and reporting is handled for trials funded or co-sponsored with industry, if different from standard procedure.

-Disciplinary actions that may be taken by your institution against investigators failing to comply with any of the relevant policies provided.

Please ensure the effective/publication date of any provided documentation is clear whenever possible.

2. Please provide the following information on university administrative or support staff, not including the Primary Investigators of specific studies, who are explicitly tasked by their job description with oversight in ensuring trials are registered and reported at your institution:

-the number of staff with any part of their job explicitly related to these activities

-Full/Whole Time Equivalents (FTE) dedicated to these activities

-Job titles and descriptions

-Grades of positions

-If any of these posts are currently vacant

If these tasks are not centralised within specific individuals, please provide any documentation available which explains how staff undertake trial registration/reporting tasks or acknowledge that no specific documentation exists in this area.

3. Please provide any standard operating procedures, documentation, or relevant policies detailing trials transparency monitoring at your institution either overall or for relevant trial-conducting division(s) within your institution.

If you provide more than one document, or refer to document(s) provided in another response, please indicate which document applies to which of the following criteria and if possible the relevant sections (or if no documentation exists for that criteria):

-How trial registration and results reporting is monitored at your University.
How investigators are notified that results are due to report.
Whether past registration and reporting are considered during the process of new trials being planned and approved within the institution.

In addition, please provide any information on disciplinary actions taken by your institution related to clinical trial registration and/or reporting, in the last 5 years and any official audits of clinical trial registration and/or results reporting conducted at your institution in the last 5 years. If this information does not exist, please acknowledge this in your response.

If the fulfillment of this request is to be delayed due to the COVID-19 pandemic, please inform me of this and the expected time in which you believe you will be able to honor the request. I am happy to allow a reasonable amount of extra time to fulfill any requests.

Best
Nicholas DeVito

Information Compliance Shared mailbox, Bangor University

Diolch am eich neges. Mae staff y Brifysgol yn gweithio o adref ar hyn o
bryd, ac oherwydd hynny, y dull gorau o gysylltu â ni fydd drwy e-bost.
Byddwn yn ymateb mor fuan â phosib i'ch ymholiad.

 

Ar gyfer ymholiadau'r Iechyd a Diogelwch cysylltwch â
[1][email address]

 

Ar gyfer ymholiadau’r Mewnfudo cysylltwch â [2][email address]

 

Ar gyfer ymholiadau sy’n gysylltiedig â Rhyddid Gwybodaeth cysylltwch â
[3][Bangor University request email]

 

Ar gyfer ymholiadau yn ymwneud â chwynion cysylltwch â
[4][email address]

Ar gyfer ymholiadau yn ymwneud ag apeliadau academaidd cysylltwch  â 
[email address]

 

 

Diolch,

Gwenan

 

 

Thank you for your message. The University's staff are currently working
from home and therefore the best way to contact us is by e-mail. We will
respond to your enquiry as quickly as possible.

 

For Health and Safety enquiries, please contact
[5][email address]

 

For enquiries relating to Immigration, please contact
[6][email address]

 

For enquiries relating to Freedom of Information, please contact
[7][Bangor University request email]

 

For enquiries relating to Complaints, please contact
[8][email address]

 

For enquiries relating to Academic Appeals, please contact
[9][email address]

 

Thank you.

 

 

Gwenan

 

Mae croeso i chi gysylltu gyda'r Brifysgol yn Gymraeg neu Saesneg

You are welcome to contact the University in Welsh or English

Rhif Elusen Gofrestredig 1141565 - Registered Charity No. 1141565

Gall y neges e-bost hon, ac unrhyw atodiadau a anfonwyd gyda hi, gynnwys
deunydd cyfrinachol ac wedi eu bwriadu i'w defnyddio'n unig gan y sawl y
cawsant eu cyfeirio ato (atynt). Os ydych wedi derbyn y neges e-bost hon
trwy gamgymeriad, rhowch wybod i'r anfonwr ar unwaith a dilewch y neges.
Os na fwriadwyd anfon y neges atoch chi, rhaid i chi beidio a defnyddio,
cadw neu ddatgelu unrhyw wybodaeth a gynhwysir ynddi. Mae unrhyw farn neu
safbwynt yn eiddo i'r sawl a'i hanfonodd yn unig ac nid yw o anghenraid yn
cynrychioli barn Prifysgol Bangor. Nid yw Prifysgol Bangor yn gwarantu bod
y neges e-bost hon neu unrhyw atodiadau yn rhydd rhag firysau neu 100% yn
ddiogel. Oni bai fod hyn wedi ei ddatgan yn uniongyrchol yn nhestun yr
e-bost, nid bwriad y neges e-bost hon yw ffurfio contract rhwymol - mae
rhestr o lofnodwyr awdurdodedig ar gael o Swyddfa Cyllid Prifysgol Bangor.

This email and any attachments may contain confidential material and is
solely for the use of the intended recipient(s). If you have received this
email in error, please notify the sender immediately and delete this
email. If you are not the intended recipient(s), you must not use, retain
or disclose any information contained in this email. Any views or opinions
are solely those of the sender and do not necessarily represent those of
Bangor University. Bangor University does not guarantee that this email or
any attachments are free from viruses or 100% secure. Unless expressly
stated in the body of the text of the email, this email is not intended to
form a binding contract - a list of authorised signatories is available
from the Bangor University Finance Office.

References

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9. mailto:[email address]

Information Compliance Shared mailbox, Bangor University

Our Ref. FOI2095

 

Dear Nicholas DeVito,

 

Thank you for your Freedom of Information request, received by email on
the 10^th August 2020.

 

We will now consider your request and you will receive the information
requested within the statutory timescale of 20 working days, as defined by
the Freedom of Information Act 2000, subject to the information not being
exempt or containing reference to a third party.

 

For your information, the Act defines a number of exemptions which may
prevent release of the information you have requested. There will be an
assessment, and if any of the exemption categories apply then the
information will not be released. You will be informed if this is the
case, including your rights of appeal.

 

If the information you requested contains reference to a third party, then
they may be consulted prior to a decision being taken on whether or not to
release the information to you. You will be informed if this is the case.

 

If you have any queries please contact us.

 

Kind regards,

Compliance Team

 

[1]http://www.bangor.ac.uk/emailtpl/logo-a2... Tîm Cydymffurfio Compliance Team

Llywodraethu a Chydymffurfio Governance and Compliance

Gwasanaethau Corfforaethol Corporate Services

E-bost: [2][Bangor University request email] Email: [8][Bangor University request email]

Prifysgol Bangor, Bangor, Gwynedd, LL57 2DG Bangor University, Bangor, Gwynedd, LL57 2DG

Elusen Gofrestredig: Rhif 1141565 Registered Charity: No. 1141565

[3]http://www.bangor.ac.uk/emailtpl/twitter... [9]http://www.bangor.ac.uk/emailtpl/twitter...
[5]http://www.bangor.ac.uk/emailtpl/faceboo... [11]http://www.bangor.ac.uk/emailtpl/faceboo...

[7]FfRhA Aur [13]TEF Gold

 

 

 

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Information Compliance Shared mailbox, Bangor University

Our Ref. FOI2095

 

Dear Nicholas DeVito,

 

The deadline for responding to your request is today. However, we are
experiencing a delay in processing your request due to staff absence and
will not be able to respond by this deadline.

 

Please accept our sincere apologies, we will endeavour to send you a
response as soon as possible.

 

Kind regards

Compliance Team

 

 

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Hello,

Many thanks for letting me know. I am happy to allow additional time given the circumstances. Please do keep me informed about the expected timeline in which you believe you will be able to fulfil the request.

Best,
Nicholas DeVito

Hello,

I just wanted to check in on the status of this request. It has now been almost 2 months since you requested an extension to provide a response.

Best,
Nicholas DeVito

Dear University of Bangor,

I am writing a final request for information based on my initial request dated 10 August 2020. I hope that delays and issues related to the ongoing pandemic have resolved enough to where my request could please be re-considered and appropriately responded to.

You can view my original request is available at:
https://www.whatdotheyknow.com/request/d...

Best,
Nicholas DeVito

Information Compliance Shared mailbox, Bangor University

Diolch am eich neges. Mae staff y Brifysgol yn gweithio o adref ar hyn o
bryd, ac oherwydd hynny, y dull gorau o gysylltu â ni fydd drwy e-bost.
Byddwn yn ymateb mor fuan â phosib i'ch ymholiad.

 

Ar gyfer ymholiadau'r Iechyd a Diogelwch cysylltwch â
[1][email address]

 

Ar gyfer ymholiadau’r Mewnfudo cysylltwch â [2][email address]

 

Ar gyfer ymholiadau sy’n gysylltiedig â Rhyddid Gwybodaeth cysylltwch â
[3][Bangor University request email]

 

Ar gyfer ymholiadau yn ymwneud â chwynion cysylltwch â
[4][email address]

Ar gyfer ymholiadau yn ymwneud ag apeliadau academaidd cysylltwch  â 
[email address]

 

 

Diolch,

Gwenan

 

 

Thank you for your message. The University's staff are currently working
from home and therefore the best way to contact us is by e-mail. We will
respond to your enquiry as quickly as possible.

 

For Health and Safety enquiries, please contact
[5][email address]

 

For enquiries relating to Immigration, please contact
[6][email address]

 

For enquiries relating to Freedom of Information, please contact
[7][Bangor University request email]

 

For enquiries relating to Complaints, please contact
[8][email address]

 

For enquiries relating to Academic Appeals, please contact
[9][email address]

 

Thank you.

 

 

Gwenan

 

Mae croeso i chi gysylltu gyda'r Brifysgol yn Gymraeg neu Saesneg

You are welcome to contact the University in Welsh or English

Rhif Elusen Gofrestredig 1141565 - Registered Charity No. 1141565

Gall y neges e-bost hon, ac unrhyw atodiadau a anfonwyd gyda hi, gynnwys
deunydd cyfrinachol ac wedi eu bwriadu i'w defnyddio'n unig gan y sawl y
cawsant eu cyfeirio ato (atynt). Os ydych wedi derbyn y neges e-bost hon
trwy gamgymeriad, rhowch wybod i'r anfonwr ar unwaith a dilewch y neges.
Os na fwriadwyd anfon y neges atoch chi, rhaid i chi beidio a defnyddio,
cadw neu ddatgelu unrhyw wybodaeth a gynhwysir ynddi. Mae unrhyw farn neu
safbwynt yn eiddo i'r sawl a'i hanfonodd yn unig ac nid yw o anghenraid yn
cynrychioli barn Prifysgol Bangor. Nid yw Prifysgol Bangor yn gwarantu bod
y neges e-bost hon neu unrhyw atodiadau yn rhydd rhag firysau neu 100% yn
ddiogel. Oni bai fod hyn wedi ei ddatgan yn uniongyrchol yn nhestun yr
e-bost, nid bwriad y neges e-bost hon yw ffurfio contract rhwymol - mae
rhestr o lofnodwyr awdurdodedig ar gael o Swyddfa Cyllid Prifysgol Bangor.

This email and any attachments may contain confidential material and is
solely for the use of the intended recipient(s). If you have received this
email in error, please notify the sender immediately and delete this
email. If you are not the intended recipient(s), you must not use, retain
or disclose any information contained in this email. Any views or opinions
are solely those of the sender and do not necessarily represent those of
Bangor University. Bangor University does not guarantee that this email or
any attachments are free from viruses or 100% secure. Unless expressly
stated in the body of the text of the email, this email is not intended to
form a binding contract - a list of authorised signatories is available
from the Bangor University Finance Office.

References

Visible links
1. mailto:[email address]
2. mailto:[email address]
3. mailto:[Bangor University request email]
4. mailto:[email address]
5. mailto:[email address]
6. mailto:[email address]
7. mailto:[Bangor University request email]
8. mailto:[email address]
9. mailto:[email address]

Information Compliance Shared mailbox, Bangor University

Our Ref. FOI2095

 

Dear Nicholas DeVito,

 

Sincere apologies for the delay, our colleagues are just finalising the
response. We will send this to you as soon as possible.

 

Kind regards

Compliance Team

 

 

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Information Compliance Shared mailbox, Bangor University

1 Attachment

Our Ref. FOI2095

 

Dear Nicholas DeVito,

 

Further to your request for information, the University's response is
below/attached:

 

BU hosts the North Wales Organisation for Randomised Trials in Health and
Social Care (NWORTH). NWORTH sits within the School of Health Sciences in
the College of Human Sciences in Bangor University and supports the
majority of BU’s clinical trials.  NWORTH is registered with UK Clinical
Research Collaboration (UKCRC) and supports transparency in line with the
requirements of this registration. NWORTH reports its research and
maintains regulatory compliance through adherence to Standard Operating
Procedures (SOPs), education and training.  NWORTH’s SOPs include core
procedures for the conduct and the reporting of clinical trials.  NWORTH
has a SOP for End of Trial Reporting (NWORTH 3.06), last updated in June
2020 (attached).  The Quality Assurance Officer at NWORTH has overall
responsibility for ensuring that corrective / preventive actions are
undertaken and are effective at a CTU level. A smaller number of clinical
trials are registered and reported on ClinicalTrials.gov. All clinical
trials are preregistered and published in journals that expect
preregistration. Finally, BU is now undertaking a restructuring of its
entire research governance arrangements. This includes enhancing support
for the pre-registration, where appropriate,  of all research protocols
(clinical and non-clinical), the public deposition of datasets and
reporting functions.

 

 

Please note that the University has a formal complaints procedure. If you
are unhappy with the service you have received in relation to your request
and wish to make a complaint or request a review of our decision you
should write to the University’s Governance & Compliance Office in the
first instance ([1][Bangor University request email]) explaining the grounds
for your complaint. In line with guidance from the Information
Commissioner’s Office, an appeal request must be submitted within two
months of the University’s final response to this Freedom of Information
Act request.

 

Kind regards,

Compliance Team

 

[2][IMG] Tîm Cydymffurfio Compliance Team

Llywodraethu a Chydymffurfio Governance and Compliance

Gwasanaethau Corfforaethol Corporate Services

E-bost: Email:
[3][Bangor University request email] [9][Bangor University request email]

Prifysgol Bangor, Bangor, Bangor University, Bangor,
Gwynedd, LL57 2DG Gwynedd, LL57 2DG

Elusen Gofrestredig: Rhif 1141565 Registered Charity: No. 1141565

[4][IMG][5]@prifysgolbangor [10][IMG][11]@BangorUni
[6][IMG][7]/PrifysgolBangor [12][IMG][13]/BangorUniversity

[8]FfRhA Aur [14]TEF Gold

 

 

 

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