Site validation pack

Edinburgh Clinical Trials Unit

Edinburgh CTU

Generated 6 Oct 2026, 10:34 · ID 49

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	18 of 35 reviewable fields are cited to a source (51%) · 3 with no source yet · 14 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	Edinburgh Clinical Trials Unit	Field-cited	Edinburgh Clinical Trials \| Usher Institute https://www.ed.ac.uk/usher/edinburgh-clinical-trials Section: Clinical Trials Strategy “Edinburgh Clinical Trials Unit” Page: https://www.ed.ac.uk/usher/edinburgh-clinical-trials	Response for Site nameAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Short name Recommended	Edinburgh CTU	Field-cited	Edinburgh Clinical Trials \| Usher Institute https://www.ed.ac.uk/usher/edinburgh-clinical-trials Section: Clinical Trials Strategy “Edinburgh Clinical Trials Unit” Page: https://www.ed.ac.uk/usher/edinburgh-clinical-trials The seed abbreviation Edinburgh CTU is the standard short form of the named unit.	Response for Short nameAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Organisation Required	University of Edinburgh	Field-cited	Edinburgh Clinical Trials \| Usher Institute https://www.ed.ac.uk/usher/edinburgh-clinical-trials Section: Clinical Trials Strategy “underpinned by the University of Edinburgh’s Research Strategies” Page: https://www.ed.ac.uk/usher/edinburgh-clinical-trials	Response for OrganisationAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Site type Recommended	CTU	Field-cited	UKCRC Registered CTUs Network - Our Members https://ukcrc-ctu.org.uk/our-members/ Section: Fully Registered Units “Edinburgh Clinical Trials Unit, Edinburgh” Page: https://ukcrc-ctu.org.uk/our-members/ Listed in the UKCRC Registered CTUs Network, so site_type=ctu per data dictionary.	Response for Site typeAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Website URL Recommended	https://www.ed.ac.uk/usher/edinburgh-clinical-trials	Field-cited	Edinburgh Clinical Trials \| Usher Institute https://www.ed.ac.uk/usher/edinburgh-clinical-trials Section: Page URL “https://www.ed.ac.uk/usher/edinburgh-clinical-trials” Page: https://www.ed.ac.uk/usher/edinburgh-clinical-trials	Response for Website URLAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Description Required	UKCRC-registered Clinical Trials Unit at the University of Edinburgh providing trial planning, delivery, data management, and trial methodology support.	Field-cited	Edinburgh Clinical Trials \| Usher Institute https://www.ed.ac.uk/usher/edinburgh-clinical-trials Section: Supporting Trials + Clinical Trials Methodology “ECTU is able to offer support at all stages of the development and progress of a clinical trial from trial planning to trial delivery and reporting.” Page: https://www.ed.ac.uk/usher/edinburgh-clinical-trials Description also reflects data management and methodology support described on ECTU pages.	Response for DescriptionAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Active site Recommended	Yes	Field-cited	Edinburgh Clinical Trials \| Usher Institute https://www.ed.ac.uk/usher/edinburgh-clinical-trials Section: Published date “This article was published on 2024-09-24” Page: https://www.ed.ac.uk/usher/edinburgh-clinical-trials Recent publication date on active ECTU pages 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	Scotland	Field-cited	How to get your trial adopted and access support \| Edinburgh Clinical Trials \| Usher Institute https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support Section: Address “Edinburgh BioQuarter - Gate 3 Edinburgh EH16 4UX” Page: https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support City is Edinburgh in Scotland, so region is Scotland using UK regions vocabulary.	Response for UK regionAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Country Recommended	Scotland	Field-cited	How to get your trial adopted and access support \| Edinburgh Clinical Trials \| Usher Institute https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support Section: Address “Edinburgh” Page: https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support Edinburgh is in Scotland; country set to Scotland.	Response for CountryAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
City Recommended	Edinburgh	Field-cited	How to get your trial adopted and access support \| Edinburgh Clinical Trials \| Usher Institute https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support Section: Address “Edinburgh BioQuarter - Gate 3 Edinburgh EH16 4UX” Page: https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support	Response for CityAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Latitude Recommended	55.9443000	Not published	Searched — not published UNSOURCEABLE in this pass: latitude retained from prior seed and not independently re-verified against a downloaded map source.	Response for LatitudeAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Longitude Recommended	-3.1893000	Not published	Searched — not published UNSOURCEABLE in this pass: longitude retained from prior seed and not independently re-verified against a downloaded map source.	Response for LongitudeAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Catchment population Recommended	850,000	Field-cited	NHS Lothian Charity Annual Report and Financial Statements 2023/2024 https://nhslothiancharity.org/wp-content/uploads/2024/09/NHSLC_A4_Annual_Report_2024_WEB.pdf Section: Partner NHS Lothian summary “>850,000: population of Lothian” Page: https://nhslothiancharity.org/wp-content/uploads/2024/09/NHSLC_A4_Annual_Report_2024_WEB.pdf Used as best available population context for the NHS Lothian partner catchment.	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 generic site contact person in accessed public pages.	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 reliably extracted contact email in downloaded page content used for this pass.	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: lead PI field not published on ECTU overview/support pages.	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: PI contact email not published on ECTU overview/support pages.	Response for PI emailAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
NHS trust partner Recommended	NHS Lothian	Field-cited	Supporting Trials \| Edinburgh Clinical Trials \| Usher Institute https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials Section: Governance “The Academic and Clinical Central Office for Research and Development (ACCORD) is a joint office comprising clinical research management staff from NHS Lothian and the University of Edinburgh.” Page: https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials	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 public statement of IMP pharmacy or dispensing facilities on accessed ECTU pages; left at default 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: accessed pages describe CTU services and address but do not explicitly confirm dedicated CRF-style facility provision.	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 bed count on ECTU or UKCRC member pages.	Response for CRF bed countAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
EDC experience Recommended	Yes	Field-cited	Supporting Trials \| Edinburgh Clinical Trials \| Usher Institute https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials Section: Data Management “ECTU has an experienced team who provide a range of data management services and enable the creation of systems that provide a successful infrastructure for research projects.” Page: https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials Data management systems and infrastructure support indicate EDC experience.	Response for EDC experienceAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
GCP certified Recommended	Yes	Field-cited	Supporting Trials \| Edinburgh Clinical Trials \| Usher Institute https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials Section: Supporting Trials “All ECTU studies are conducted in accordance with ICH GCP.” Page: https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials	Response for GCP certifiedAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
NIHR CRN partner Recommended	No	Field-cited	How to get your trial adopted and access support \| Edinburgh Clinical Trials \| Usher Institute https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support Section: ECTU Trial Portfolio and UKCRC Registration “Funders of large scale academic clinical trials (e.g. NIHR) often request that a Registered Clinical Trials Unit is involved in the application.” Page: https://usher.ed.ac.uk/edinburgh-clinical-trials/supporting-trials/how-to-access-ectu-support This supports NIHR-linked trial support but does not evidence CRN partnership; field set FALSE conservatively.	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 numeric count of ECTU delivery staff on accessed pages.	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: no annual mental-health trial throughput figure published for ECTU.	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 current competing-study count published for ECTU.	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 statistic published for ECTU.	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 approval timeline for this site found on public sources searched.	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
Capabilities Recommended	No value held	No source yet	No citation linked to this field yet.	Response for CapabilitiesAccurateNeeds 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 · Some · prev trials: 1	Field-cited	ISRCTN API search archive for Edinburgh CTU https://www.isrctn.com/api/query/format/default Section: ISRCTN99672552 scientificTitle “Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial” Page: https://www.isrctn.com/api/query/format/default Mapped to Schizophrenia (diagnosis_area_id=1) as the trial is for clozapine-unresponsive psychosis spectrum; previous_trial_count=1 and experience_level=some.	Response for Diagnosis experience: SchizophreniaAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Diagnosis experience: Bipolar disorder Recommended	Bipolar disorder · Mood Disorders · Some · prev trials: 1	Field-cited	ISRCTN API search archive for Edinburgh CTU https://www.isrctn.com/api/query/format/default Section: ISRCTN72151939 scientificTitle “A randomised, double-blind, placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment-resistant bipolar depression” Page: https://www.isrctn.com/api/query/format/default Mapped to Bipolar disorder (diagnosis_area_id=4); previous_trial_count=1 and experience_level=some from explicit bipolar trial evidence.	Response for Diagnosis experience: Bipolar disorderAccurateNeeds correctionNot sureDoes not apply No response selected	No notes
Diagnosis experience: Transdiagnostic (anxiety-depression) Recommended	Transdiagnostic (anxiety-depression) · Transdiagnostic · Some · prev trials: 1	Field-cited	ISRCTN API search archive for Edinburgh CTU https://www.isrctn.com/api/query/format/default Section: ISRCTN43130832 scientificTitle “i-Minds: a digital intervention to improve mental health and interpersonal resilience for young people who have experienced online sexual abuse - a non-randomised feasibility clinical trial and nested qualitative study” Page: https://www.isrctn.com/api/query/format/default Mapped to Transdiagnostic (diagnosis_area_id=32) due broad mental health and resilience framing without single diagnosis category; previous_trial_count=1 and experience_level=some.	Response for Diagnosis experience: Transdiagnostic (anxiety-depression)AccurateNeeds 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 2026-04-15 from ed.ac.uk ECTU pages, UKCRC CTU members list, ClinicalTrials.gov API v2 and ISRCTN API query union, and NHS Lothian annual report snippet for Lothian population context.	Internal	Internal catalogue field	—	—