Details on Trials Transparency at University of Aberdeen

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Dear University of Aberdeen,

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

Foi, University of Aberdeen

Dear Nicholas DeVito,
I refer to your email of 10 August 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 as soon as possible and within the statutory timescales.

Yours sincerely,
Mary Sabiston
Information Compliance Officer
University of Aberdeen

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Foi, University of Aberdeen

9 Attachments

Dear Nicholas DeVito,

FREEDOM OF INFORMATION REQUEST FOI 2020-220

I refer to your email of 10 August 2020 requesting information relating to trails transparency.

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

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.

SOP-QA-3 V4 (Protocol guidance for high risk trials and CTIMPs) attached.
SOP-QA-33 V3 (Research project publication and dissemination) attached.

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.

SOP-QA-4 V4 (Applying for sponsorship) attached.

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

SOP-QA-33 V3.

-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).

SOP-QA-33 sec 3.19

-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.

SOP-QA-5 (Sponsorship review and risk assessment) attached.

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

As stated in the SOPs noted above.

-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.

SOP-QA-3 sec 3.4

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

Effective date is stated on all SOPs.

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

Research Governance Team - three staff.
Quality Assurance Team - four staff (NHS staff, with a Framework agreement in place between University and NHS to provide Research Governance and Quality Assurance service across both organisations).

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

Research Governance - 2 WTE.
Quality Assurance - 3.2 WTE.

-Job titles and descriptions
-Grades of positions

Research Governance Manager – Grade 7
Research Governance Officer - Grade 6
Quality Assurance Manager – NHS AfC Grade 8B
Quality Assurance Support Officer - NHS AfC Grade 6
Research Monitor x 2 - NHS AfC Grade 6

-If any of these posts are currently vacant
No.

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.
N/A.

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.

SOP-QA-28 V3 (Monitoring) attached, TMP-QA-59 V5 (Monitoring Plan) attached and TMP-QA-48 V8 (Monitoring checklist) attached.

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.

SOP-QA-28 V3 and TMP-QA-48 V8 attached.

How investigators are notified that results are due to report.

SOP-QA-31 V3 (Research project closure) attached.

Whether past registration and reporting are considered during the process of new trials being planned and approved within the institution.
Considered as part of Sponsorship risk assessment.

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.

No disciplinary actions taken.
Annual audits conducted of clinical trial registration and publication process. The most recent (IQA-93) from August 2019 is attached.

Should you be dissatisfied with this response, you have the right to request a review. A request for review must be made within 40 working days of the receipt 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 [University of Aberdeen request email].

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 receipt of the University’s review response. Details on how to make an appeal to the Commissioner are available at www.itspublicknowledge.info/Appeal. Should you be dissatisfied with the Commissioner’s decision, you have a right of appeal to the Court of Session on a point of law.

Yours sincerely,
Mary Sabiston
Information Compliance Officer
University of Aberdeen

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