Site validation pack

Sheffield Clinical Trials Research Unit

Sheffield CTRU

Generated 6 Oct 2026, 10:34 · ID 47

Unverified

Last verified: 15/04/2026

Instructions for reviewers

Review each field against your knowledge of this site. Mark Accurate if the value is right, Needs correction if it is wrong or inaccurate (add notes), Not sure if you cannot verify it, or Does not apply if the field is not relevant.
Evidence shown is from our source registry. Fields marked No source yet hold values we could not yet pin to a document — those were AI-inferred and need your input most. Fields marked Searched — not published are ones we looked for and could not find publicly; the note lists where we checked.
Your selections and notes are kept in this browser tab only (not sent to the database). Print or save as PDF when finished, then return it to the DIGIT team.

Overview

Total fields

Field-cited

Whole-record source only

AI-inferred, no source yet

Searched — not published

No value held

Needs review

Source coverage

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Field-level source coverage Optional	19 of 36 reviewable fields are cited to a source (53%) · 2 with no source yet · 15 searched — not published · 13 with no value held	Computed	No citation linked to this field yet.	Response for Field-level source coverageAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Identity and organisation

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Site name Required	Sheffield Clinical Trials Research Unit	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Header “Clinical Trials Research Unit” Page: https://www.sheffield.ac.uk/ctru	Response for Site nameAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Short name Recommended	Sheffield CTRU	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Header “Clinical Trials Research Unit” Page: https://www.sheffield.ac.uk/ctru Short name retained as Sheffield CTRU, the public shorthand used across CTRU pages and registry listings.	Response for Short nameAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Organisation Required	University of Sheffield	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Contact us “The University of Sheffield” Page: https://www.sheffield.ac.uk/ctru	Response for OrganisationAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Site type Recommended	CTU	Field-cited	UKCRC Registered CTUs https://ukcrc-ctu.org.uk/registered-ctus/ Section: Fully Registered Units “Sheffield Clinical Trials Research Unit” Page: https://ukcrc-ctu.org.uk/registered-ctus/ UKCRC confirms this is a registered Clinical Trials Unit; site_type=ctu per data-dictionary.	Response for Site typeAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Website URL Recommended	https://www.sheffield.ac.uk/ctru	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Page URL “https://www.sheffield.ac.uk/ctru” Page: https://www.sheffield.ac.uk/ctru	Response for Website URLAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Description Required	UKCRC-registered Clinical Trials Research Unit at the University of Sheffield providing trial design, conduct, analysis, and reporting support across complex interventions including mental health trials.	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Overview “The Clinical Trials Research Unit (CTRU) is a UKCRC-registered clinical trials unit providing high-quality support in running clinical trials in line with international regulatory standards, from the planning stages right through to analysis and reporting.” Page: https://www.sheffield.ac.uk/ctru	Response for DescriptionAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Active site Recommended	Yes	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Overview “providing high-quality support in running clinical trials” Page: https://www.sheffield.ac.uk/ctru Current-tense operational description supports active=TRUE.	Response for Active siteAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Location and scope

Field	Current value	Evidence	Source evidence	Response	Notes / correction
UK region Recommended	Yorkshire and the Humber	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Contact address “Barber House ... Sheffield S10 2HQ” Page: https://www.sheffield.ac.uk/ctru Region normalized to controlled vocabulary: Yorkshire and the Humber.	Response for UK regionAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Country Recommended	England	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Contact address “Sheffield S10 2HQ” Page: https://www.sheffield.ac.uk/ctru UK address in Sheffield implies country=England for this record.	Response for CountryAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
City Recommended	Sheffield	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Contact address “Sheffield S10 2HQ” Page: https://www.sheffield.ac.uk/ctru	Response for CityAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Latitude Recommended	53.3811000	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Contact address “Barber House 387 Glossop Road Sheffield S10 2HQ” Page: https://www.sheffield.ac.uk/ctru Coordinates retained as geocode for the published Barber House address.	Response for LatitudeAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Longitude Recommended	-1.4886000	Field-cited	University of Sheffield — Clinical Trials Research Unit https://www.sheffield.ac.uk/ctru Section: Contact address “Barber House 387 Glossop Road Sheffield S10 2HQ” Page: https://www.sheffield.ac.uk/ctru Coordinates retained as geocode for the published Barber House address.	Response for LongitudeAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Catchment population Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: CTRU is a university CTU and does not publish a defined service catchment population; searched CTRU pages, NIHR partners page, and STH annual report.	Response for Catchment populationAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Geographic coverage Recommended	No value held	No source yet	No citation linked to this field yet.	Response for Geographic coverageAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Contacts and leadership

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Contact name Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no named single contact person is published on the CTRU pages used.	Response for Contact nameAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Contact email Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no direct contact email is present on the downloaded CTRU pages used for this verification.	Response for Contact emailAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Principal investigator Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no public site-level PI field identified on the pages searched.	Response for Principal investigatorAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
PI email Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no PI email published on the cited sources.	Response for PI emailAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
NHS trust partner Recommended	Sheffield Teaching Hospitals NHS Foundation Trust	Field-cited	NIHR Sheffield CRF — Our collaborators/partners https://www.sheffield.crf.nihr.ac.uk/about-us/our-collaboratorspartners Section: Our collaborators/partners “Sheffield Teaching Hospitals NHS Foundation Trust (STH)” Page: https://www.sheffield.crf.nihr.ac.uk/about-us/our-collaboratorspartners	Response for NHS trust partnerAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Infrastructure

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Pharmacy facilities Recommended	No	Not published	Searched — not published UNSOURCEABLE as TRUE: no explicit on-site IMP pharmacy facility claim for the CTRU pages searched; field retained FALSE.	Response for Pharmacy facilitiesAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Dedicated research facility Recommended	No	Not published	Searched — not published UNSOURCEABLE as TRUE: no dedicated CTRU inpatient research facility statement on cited pages; field retained FALSE.	Response for Dedicated research facilityAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
CRF bed count Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no CTRU-specific bed count published in sources searched.	Response for CRF bed countAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
EDC experience Recommended	No	Not published	Searched — not published UNSOURCEABLE as explicit boolean from public pages; retained FALSE conservatively.	Response for EDC experienceAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
GCP certified Recommended	No	Not published	Searched — not published UNSOURCEABLE as explicit site-level statement in public sources searched; retained FALSE conservatively.	Response for GCP certifiedAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
NIHR CRN partner Recommended	Yes	Field-cited	NIHR Sheffield CRF — Our collaborators/partners https://www.sheffield.crf.nihr.ac.uk/about-us/our-collaboratorspartners Section: Our collaborators/partners “NIHR Research Delivery Network (RDN)” Page: https://www.sheffield.crf.nihr.ac.uk/about-us/our-collaboratorspartners CTRU is listed among NIHR-connected collaborators; is_nihr_crn_partner set TRUE in site seed update.	Response for NIHR CRN partnerAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Operational capacity

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Research staff count Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no staff count metric on cited sources.	Response for Research staff countAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Annual MH trial count Recommended	No value held	Not published	Searched — not published UNSOURCEABLE as single scalar; condition-specific activity is captured in site_diagnosis_experience rows.	Response for Annual MH trial countAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Active competing studies Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no published scalar count in sourced pages.	Response for Active competing studiesAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Typical monthly recruitment rate Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no monthly recruitment metric published.	Response for Typical monthly recruitment rateAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
R&D approval timeline (days) Recommended	No value held	Not published	Searched — not published UNSOURCEABLE: no R&D timeline metric published for this CTU.	Response for R&D approval timeline (days)AccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Capabilities

Research capabilities available at this site.

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Capability: Platform trial experience Recommended	Trial Methodology · Platform trial experience · CTRU current portfolio includes active work on platform trial design and analysis methods (APT-SAP). · Available	Field-cited	University of Sheffield CTRU — Current trials and studies https://www.sheffield.ac.uk/ctru/current-trials Section: APT-SAP “Enhancing the design, conduct and analysis of Adaptive and Platform Trials through consensus-driven Statistical Analysis Plan guidance.” Page: https://www.sheffield.ac.uk/ctru/current-trials Mapped to capability_type_id 44 (Platform trial experience).	Response for Capability: Platform trial experienceAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Capability: Adaptive trial experience Recommended	Trial Methodology · Adaptive trial experience · CTRU current portfolio includes active work on adaptive trial design and analysis methods (APT-SAP). · Available	Field-cited	University of Sheffield CTRU — Current trials and studies https://www.sheffield.ac.uk/ctru/current-trials Section: APT-SAP “Enhancing the design, conduct and analysis of Adaptive and Platform Trials through consensus-driven Statistical Analysis Plan guidance.” Page: https://www.sheffield.ac.uk/ctru/current-trials Mapped to capability_type_id 45 (Adaptive trial experience).	Response for Capability: Adaptive trial experienceAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Diagnosis experience

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Diagnosis experience: Schizophrenia Recommended	Schizophrenia · Psychotic Disorders · Moderate · prev trials: 2	Field-cited	ClinicalTrials.gov API query — Sheffield mental health studies https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Section: API query output “totalCount: 26” Page: https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Keyword mapping of completed Sheffield trials in unioned registry outputs supports previous_trial_count=2 for diagnosis_area_id 1. University of Sheffield CTRU — STEPWISE research study https://www.sheffield.ac.uk/ctru/completed-trials/stepwise Section: STEPWISE trial “STEPWISE is an individually randomised controlled trial ... for adults with schizophrenia ... schizoaffective disorder and first-episode psychosis” Page: https://www.sheffield.ac.uk/ctru/completed-trials/stepwise At least two completed psychosis/schizophrenia-relevant studies identified across ClinicalTrials.gov and ISRCTN query outputs for Sheffield; moderate threshold (2-4) applied.	Response for Diagnosis experience: SchizophreniaAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Diagnosis experience: Major depressive disorder Recommended	Major depressive disorder · Mood Disorders · Extensive · prev trials: 8	Field-cited	ClinicalTrials.gov API query — Sheffield mental health studies https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Section: API query output “totalCount: 26” Page: https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Union of mandatory ClinicalTrials.gov and ISRCTN queries yields >=5 completed depression-relevant studies linked to Sheffield/CTRU context; extensive threshold (>=5) applied. ClinicalTrials.gov API query — Sheffield mental health studies https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Section: API query output “totalCount: 26” Page: https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Retained previous_trial_count=8 from existing data; count is consistent with completed depression-mapped studies from mandatory registry query set.	Response for Diagnosis experience: Major depressive disorderAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Diagnosis experience: Generalised anxiety disorder Recommended	Generalised anxiety disorder · Anxiety Disorders · Extensive · prev trials: 5	Field-cited	ClinicalTrials.gov API query — Sheffield mental health studies https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Section: API query output “totalCount: 26” Page: https://clinicaltrials.gov/api/v2/studies?query.locn=Sheffield%2C%20United%20Kingdom&query.cond=depression%20OR%20anxiety%20OR%20schizophrenia%20OR%20psychosis%20OR%20bipolar&pageSize=100&countTotal=true Retained previous_trial_count=5 from existing data; consistent with mandatory registry query union and anxiety keyword mapping. University of Sheffield CTRU — Current trials and studies https://www.sheffield.ac.uk/ctru/current-trials Section: CONTACT-GAD “A randomised CONtrolled trial of Tailored Acceptance and Commitment Therapy for older people with treatment resistant Generalised Anxiety Disorder” Page: https://www.sheffield.ac.uk/ctru/current-trials Current GAD trial plus multiple anxiety/depression registry hits across mandatory ClinicalTrials.gov and ISRCTN queries supports extensive threshold (>=5).	Response for Diagnosis experience: Generalised anxiety disorderAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Linked cohorts

Cohorts hosted at or linked to this site.

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Linked cohorts Optional	No value held	No source yet	No citation linked to this field yet.	Response for Linked cohortsAccurateNeeds correctionNot sureDoes not apply No response selected	No notes

Verification metadata

Internal catalogue status — for reference only.

Field	Current value	Evidence	Source evidence	Response	Notes / correction
Verification status Recommended	unverified	Internal	Internal catalogue field	—	—
Last verified Recommended	15 Apr 2026	Internal	Internal catalogue field	—	—
Data source Recommended	Verified Apr 2026 from University of Sheffield CTRU pages, UKCRC CTU register, NIHR Sheffield CRF partners page, ClinicalTrials.gov API, ISRCTN API, and Sheffield Teaching Hospitals annual report.	Internal	Internal catalogue field	—	—