Details on Trials Transparency at University of Sheffield

The request was partially successful.

Dear University of Sheffield,

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

Dear University of Sheffield,

As the statutory timeline for a response has passed, can you please acknowledge receipt of the above request? I understand the current pandemic may be delaying responses and am happy to allow for additional time to fulfill this request, however I have not received any confirmation that my request has been received and is currently being considered.

Can you please provide information as to the current status of my request and when I might expect a response?

You can find my original request here:
https://www.whatdotheyknow.com/request/d...

Best,
Nicholas DeVito

Freedom Of Information, University of Sheffield

1 Attachment

Good morning,
Please find a response to your FOI request
Kind regards
Luke

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Hello Luke,

Many thanks for your response. It appears there were supposed to be attachments included as part of this response. The response makes reference to a number of documents and says to see "Supporting Documentation" but no additional information was included in your response. This includes:

-Sheffield CTRU’s protocol template, an appendix to Standard Operating Procedure PM003
-Sheffield CTRU Standard Operating Procedure GEN004
-A memorandum of understanding, drawn up between the University of Sheffield and Sheffield Teaching Hospitals in 2012, refers both organisations to STH’s Sponsorship Decision Chart (version 2.1, March 2008)
-The University’s ‘Procedure for monitoring and audit of transparency requirements for University-sponsored human interventional studies

Can you please send along this documentation?

Best,
Nicholas DeVito

Luke Thompson, University of Sheffield

2 Attachments

Good afternoon,

Please find the documents as discussed 
Kind regards 
Luke 

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Dear Luke,

Many thanks but this is still missing the following:

-Sheffield CTRU Standard Operating Procedure GEN004
-A memorandum of understanding, drawn up between the University of Sheffield and Sheffield Teaching Hospitals in 2012, refers both organisations to STH’s Sponsorship Decision Chart (version 2.1, March 2008)

Not sure if the MoU was meant to be made available but could you please share SOP GEN004?

Best,
Nicholas DeVito

Luke Thompson, University of Sheffield

Good afternoon Nicholas,
I have been advised that these are in draft form at the moment and rather
than section 22 being applied I will be able to forward them over to you
in the next few days.
Thank you
Luke
On Wed, 9 Sep 2020 at 20:40, Nicholas DeVito <[1][FOI #682441 email]>
wrote:

Dear Luke,

Many thanks but this is still missing the following:

-Sheffield CTRU Standard Operating Procedure GEN004
-A memorandum of understanding, drawn up between the University of
Sheffield and Sheffield Teaching Hospitals in 2012, refers both
organisations to STH’s Sponsorship Decision Chart (version 2.1, March
2008)

Not sure if the MoU was meant to be made available but could you please
share SOP GEN004?

Best,
Nicholas DeVito

show quoted sections

Great, thank you.

Best,
Nicholas DeVito

Dear Luke,

Can I request an update as to the status of the documents we previously discussed and when they may be made available? Specifically:

-Sheffield CTRU Standard Operating Procedure GEN004
-A memorandum of understanding, drawn up between the University of Sheffield and Sheffield Teaching Hospitals in 2012, refers both organisations to STH’s Sponsorship Decision Chart (version 2.1, March 2008)

Best,
Nicholas DeVito