Details on Trials Transparency at University of Warwick

Roedd y cais yn llwyddiannus.

Dear University of Warwick,

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

infocompliance, Resource, University of Warwick

Thank you for your email which has been received by the University's
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References

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1. mailto:[email address]

infocompliance, Resource, University of Warwick

7 Atodiad

Nicholas DeVito

 

Thank you for your email dated 10 August 2020 requesting information from
the University of Warwick under the Freedom of Information Act 2000.
Please find below your request and our response.

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.

Please find below (and attached) a list of documents that contain the
information requested with effective dates:

1.                SOP 28 – Transparency in Clinical Research Studies (July
2019)

2.                SOP 3 – Research Sponsorship (February 2018)

3.                University of Warwick Institutional Sponsorship &
Oversight Policy
https://warwick.ac.uk/services/ris/resea...
(November 2018)

4.                Division of Sponsor Responsibilities Form (MG to insert
if applicable)

5.                Job descriptions of professional support staff
(effective date N/A as not controlled)

6.                Warwick Clinical Trials Unit (WCTU) Governance Committee
minutes (19 Aug 2020)

7.                WCTU Report to Sponsorship and Oversight Committee (10
June 2020)

8.                Research Misconduct Guidance
[1]https://warwick.ac.uk/services/ris/resea...
(March 2018)

9.                Research Integrity -Codes of Practice & Policies
[2]https://warwick.ac.uk/services/ris/resea...

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.

1.                SOP 28 – Transparency in Clinical Research Studies (July
2019)

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

1.                SOP 28 – Transparency in Clinical Research Studies (July
2019)

-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).

1.                SOP 28 – Transparency in Clinical Research Studies (July
2019)

-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.

2.                SOP 3 – Research Sponsorship (February 2018)

3.                University of Warwick Institutional Sponsorship &
Oversight Policy
https://warwick.ac.uk/services/ris/resea...
(November 2018)

4.                Division of Sponsor Responsibilities Form (MG to insert
if applicable)

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

1.                SOP 28 – Transparency in Clinical Research Studies (July
2019)

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

N/A.

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

No disciplinary action has been taken against any investigators for
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.

SOP 28 (document 1) describes which roles are responsible for these
activities at Warwick.

The responsibility of undertaking this activity is also allocated using
the Division of Sponsor Responsibilities Form (Document 4).

 

The roles that provide support and monitor these activities are not
explicitly tasked to do so by their job description, however the job
descriptions cover activities relating to transparency with more general
wording around compliance.

 

The main staff who are responsible and provide support in this area are:

 

3 x WCTU Quality Assurance Managers, FA7, 2.2 FTE

1 x Research Governance & Quality Assurance Manager, FA7, FTE 1.0

1 x WCTU Head of Operations, FA8, FTE 0.8

1 x WCTU Deputy of Operations, FA8, FTE 1.0

5 x WCTU Senior Project Managers FA7, FTE 4.6

 

Please find attached the Job Descriptions (document 5) for all of the
above roles.

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.

Trial transparency is monitored through our governance structure as
follows:

 

o The WCTU Governance Committee have transparency as a standard agenda
item and meet regularly to review clinical trial transparency - see
document 6 - Redacted minutes from recent meeting.
o The WCTU Governance Committee Report to University Sponsorship and
Oversight Committee - see document 7 - Redacted CTU Report to SOC.
o Matters are escalated as appropriate from the Sponsorship and
Oversight Committee to the University of Warwick Research Governance
and Ethics Committee.

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.

6.                Warwick Clinical Trials Unit (WCTU) Governance Committee
minutes (19 Aug 2020)

7.                WCTU Report to Sponsorship and Oversight Committee (10
June 2020)

How investigators are notified that results are due to report.

1.                SOP 28 – Transparency in Clinical Research Studies (July
2019)

Whether past registration and reporting are considered during the process
of new trials being planned and approved within the institution.

The Sponsorship and Oversight Committee review and approve applications
for Sponsorship across the University of Warwick (document 3).  This
Committee also receives and reviews reports on clinical trial transparency
(document 7). When reviewing applications for sponsorship, the Committee
consider risks relating to the trial and team during this process and any
issues relating to past compliance with University policies and procedures
would be considered.

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.

There has been no disciplinary action taken by the University of Warwick
in relation to clinical trial registration and/or reporting or official
independent audits of clinical trial registration and/or results reporting
within the last 5 years.

We do monitor clinical trial transparency and as part of this would report
and escalate issues that are not compliant with our standard operating
procedures, guidance and policies.

Our Research Integrity Codes of Practice & Policies (see document 9)
specify that staff should aim to design, produce and disseminate work of
the highest quality and ethical standards, foster and support honesty in
research, in relation their own research and that of others. 

Any failure to comply with the Research Code of Practice or any actions
that may be deemed as misconduct could lead to disciplinary actions as set
out in the University’s Statute 28 and related Ordinances, Disciplinary
Regulation 23 or employees terms and conditions as appropriate.
Allegations of research misconduct will be investigated under the
University’s Code of Practice for the Investigation of Research
Misconduct, which could result in disciplinary actions.

If you are dissatisfied with the way in which your request has been
handled you can request an internal review within one month of our
response and, in the first instance, you are advised to follow the
procedure outlined here:
[3]http://www2.warwick.ac.uk/services/legal...

If you remain dissatisfied with how your request has been handled, you
have a right to appeal to the Information Commissioner at: The Information
Commissioner’s Office, Wycliffe House, Walter Lane, Wilmslow, and
Cheshire, SK9 5AF (0303 123 1113) ([4]https://ico.org.uk/) There is no
charge for making an appeal.

Yours sincerely,

Ian Rowley
Ian Rowley | Director of Reputation and Culture Change
University House | University of Warwick | Coventry | CV4 8UW

References

Visible links
1. https://warwick.ac.uk/services/ris/resea...
2. https://warwick.ac.uk/services/ris/resea...
3. http://www2.warwick.ac.uk/services/legal...
4. https://ico.org.uk/