Details on Trials Transparency at University of Manchester

The request was successful.

Dear University of Manchester,

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/health-topics/clinic...).

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

MTRS FOIA, University of Manchester

1 Attachment

Dear Nicholas,

 

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

 

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

 

NB Due to the current situation with the Covid-19 virus and the
University’s response to it, there may be a delay in receiving your
response at this time.

 

With best regards

 

Lisa

 

 

Dr Lisa Crawley l  Information Officer  l Information Governance Office
l Directorate of Compliance and Risk l  Professional Support Services |
Room G7 Christie Building  l Compliance & Risk Management Office l  The
University of Manchester  l  Oxford Road  l  Manchester  l  M13 9PL  l 
Tel +44 (0)161 275 8400  

[1]www.manchester.ac.uk

[2]cid:image001.jpg@01D65F8C.4B07A260

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

 

References

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1. http://www.manchester.ac.uk/
3. http://www.dataprotection.manchester.ac....

MTRS FOIA, University of Manchester

1 Attachment

Dear Nicholas,

 

Thank you for your request for information received by The University of
Manchester on 03 August 2020 and please see our responses which follow
below.

 

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.

 

·         UoM clinical trial policy was updated in April 2020 and requires
registration of all trials on a publically accessible register. It is
accessible at:
[1]http://documents.manchester.ac.uk/DocuIn...

·         UoM clinical trial sponsorship process includes checks to ensure
trial registration and obtain a signed agreement of the investigator to
register the trial (SOP attached).

·         UoMSOP07 Clinical Trial Authorisation v6, March 2018, states
requirement for trial registration to EudraCT. Accessible at
[2]http://documents.manchester.ac.uk/displa...

·         The University Publications Policy was last updated on 19^th
June 2019 and is accessible at:
[3]http://documents.manchester.ac.uk/DocuIn...

·         UoM SOP on Publication states that all CTIMPs must be registered
on the EudraCT database as a minimum. Accessible at:
[4]http://documents.manchester.ac.uk/DocuIn...

·         All University of Manchester sponsored trials have an
independent data monitoring committee to ensure oversight of results and
outcomes

·         Sponsorship review and approval process, v6.4, 29.05.2020
(Non-CTIMPs/ non-regulated clinical interventions) attached. Located in
Faculty Research Governance Pack, accessible at:
[5]http://documents.manchester.ac.uk/displa...

·         Sponsor Conditions, v10, 09.10.2018 (Non-CTIMPs/ non-regulated
clinical interventions) attached. Located in Faculty Research Governance
Pack, accessible at:
[6]http://documents.manchester.ac.uk/displa...

 

 

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.

 

·         UoM Clinical Trial Policy version 5, April 2020, section 4.5.16

·         UoMSOP22 Publication version 1, March 2018, section 5

·         UoMCTSOP03 Processing Requests for Sponsorship version 5, July
2020, section 4.2.2

·         UoMSOP07 Clinical Trial Authorisation v6, March 2018, Section
4.1

·         Non-CTIMPs/ non-regulated clinical interventions - Sponsorship
review and approval process, v6.4, 29.05.2020. Appendix 4 - evidence of
clinical trial registration must be submitted before green light issued.

 

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

 

·         UoMSOP22 Publication version 1, March 2018

·         Non-CTIMPs/ non-regulated clinical investigations – Sponsorship
review and approval process, v6.4, 29.05.2020. Appendix 7 – CI sent
reminder email one month in advance of planned closed date; reminder
covers process and study-specific requirements.  

·         Non-CTIMPs/ non-regulated clinical investigations - Sponsor
Conditions v10, 09.10.2018

 

-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).

 

·         UoM Clinical Trial Policy version 5, April 2020, section 4.5.16

·         UoMSOP22 Publication version 1, March 2018, section 5

·         UoMSOP07 Clinical Trial Authorisation v6, March 2018, Section
4.1

 

-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.

 

·         UoM Clinical Trial Policy version 5, April 2020, section 4.4

·         UoMCTSOP03 Processing Requests for Sponsorship version 5, July
2020. Sponsorship responsibility is managed by the University’s
Sponsorship team and is not assumed/handed over when investigators join or
leave.

 

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

 

·         UoMCTSOP03 Processing Requests for Sponsorship version 5, July
2020.

 

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

 

No 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.

 

If, at the end of an investigation, research misconduct is found to have
occurred, the procedures contained within the University Code of Practice
for Investigating Concerns about the Conduct of Research may form the
investigation element of any disciplinary process. The code is available
at [7]http://documents.manchester.ac.uk/displa... and should
be read in conjunction with the University’s standard disciplinary
procedures for all staff.

 

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.

 

Specific individuals are not explicitly tasked by their job descriptions
to undertake clinical trial registration and reporting. Clinical trial
registration and reporting are embedded in sponsor policies and procedures
(as provided in relation to Q1). The University’s Research Governance,
Ethics and Integrity Team (RGEIT) is responsible for developing and
monitoring University policy and providing guidance and support to
researchers in the area of research governance, integrity and ethics. The
management of University-sponsored regulated trials (CTIMPs) and
monitoring of legal/policy compliance is undertaken by the RGEIT and
overseen by the University’s Clinical Trial Management Group (CTMG).
Non-regulated University-sponsored trials are managed and monitored by a
Faculty-based Research Governance Team with oversight from the HRA
Oversight Committee (HRA OC).

 

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.

 

·         Trial registration for non-CTIMPs/ non-regulated clinical
interventions - Sponsorship review and approval process, v6.4, 29.05.2020.
All non-regulated trials/interventions are reviewed before sponsor green
light is issued to start. Appendix 4 outlines that evidence of clinical
trial registration must be submitted before the green light is issued.

·         Trial registration for CTIMPs/clinical trials -  UoMCTSOP03
Processing Requests for Sponsorship version 5, section 4.2.2 - Evidence of
trial registration is required before sponsor green light is issued.

·         UoM SOP on Publication states that all CTIMPs must be registered
on the EudraCT database as a minimum. Accessible at:
[8]http://documents.manchester.ac.uk/DocuIn.... Updates to
registration and results reporting are subject to audit by the clinical
trials team, the most recent taking place in July 2020.

 

How investigators are notified that results are due to report.

 

·         Non-CTIMPs/ non-regulated clinical investigations – Sponsorship
review and approval process, v6.4, 29.05.2020. Appendix 7 – CI sent
reminder email one month in advance of planned closed date; reminder
covers process and study-specific requirements.  

·         CTIMPS/clinical trials – investigators are notified at the point
of end of trial declaration of the deadline for publishing results, this
is monitored by the clinical trials team and reminders sent out if needed.

 

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

 

We have interpreted this question to be asking if a researcher approaches
us for Sponsorship of a new trial, we would take into account whether they
had registered and reported as expected for previous trials. If that is
correct, it isn’t currently part of our processes to consider past
registration and reporting when setting up new trials, but if a CI was not
registering and reporting on their trial we would be aware of that through
the processes already provided in the response, and we would address that
within the oversight of that trial.

 

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 as described above in the last 5
years. Clinical trial registration and results reporting are subject to
audit, the latest one on results reporting having taken place in July
2020.

 

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 Services | G7 Christie
Building | The University of Manchester | Oxford Road | Manchester | M13
9PL | Tel +44(0) 161 306 7549| [9]www.manchester.ac.uk

[10]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:
[11]www.dataprotection.manchester.ac.uk

 

References

Visible links
1. http://documents.manchester.ac.uk/DocuIn...
2. http://documents.manchester.ac.uk/displa...
3. http://documents.manchester.ac.uk/DocuIn...
4. http://documents.manchester.ac.uk/DocuIn...
5. http://documents.manchester.ac.uk/displa...
6. http://documents.manchester.ac.uk/displa...
7. http://documents.manchester.ac.uk/displa...
8. http://documents.manchester.ac.uk/DocuIn...
9. http://www.manchester.ac.uk/
11. http://www.dataprotection.manchester.ac....

Dear University of Manchester,

Many thanks for your comprehensive response. Unfortunately, a few of the links to provided documentation appear to require a log-in to the linked portal to access. Would you please provide, as attachments, the following documents referenced in your response?

The clinical trial policy (Reference [1]).

The Faculty Research Governance Pack containing the sponsorship and approval process (Reference [5])

The sponsor conditions document (Reference [6])

Thank you again and I look forward to receiving these documents.

Best,
Nicholas DeVito

MTRS FOIA, University of Manchester

2 Attachments

Hi Nicholas,

With apologies, please find those attached. As per the original response [6] is contained within [5] - the Faculty Research Governance Pack attached.

Kind regards

Sharon

Sharon Glen | Information Officer | Information Governance Office | Directorate of Compliance and Risk |Professional Services | G7 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

show quoted sections

Dear Sharon,

Many thanks again, however the html document provided for references 5 and 6 does not actually allow me to access the linked documents when downloaded on my computer. Do you have an alternate way to share those documents? Perhaps as a PDF?

Best,
Nicholas DeVito

MTRS FOIA, University of Manchester

2 Attachments

Hi Nicholas,

 

Apologies, please try this.

 

Kind regards

 

Sharon

 

Sharon Glen | Information Officer | Information Governance Office |
Directorate of Compliance and Risk |Professional Services | G7 Christie
Building | The University of Manchester | Oxford Road | Manchester | M13
9PL | Tel +44(0) 161 306 7549| [1]www.manchester.ac.uk

[2]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:
[3]www.dataprotection.manchester.ac.uk

 

 

References

Visible links
1. http://www.manchester.ac.uk/
3. http://www.dataprotection.manchester.ac....