Dear University of Edinburgh,
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.
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