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This document provides a protocol template for observational studies sponsored by UCL or UCLH, detailing regulatory, ethics, and policy requirements.
Year:
2021
Region / City:
London
Subject:
Research Protocols
Document Type:
Template
Organization:
UCL/UCLH Joint Research Office
Author:
UCL/UCLH Research Office
Target Audience:
Chief Investigators, Researchers
Period of Validity:
N/A
Approval Date:
06/01/2021
Modification Date:
N/A
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Year:
2021
Organization:
University College London (UCL) / University College London NHS Foundation Trust (UCLH)
Document Type:
Protocol template
Scope:
Data-only studies with anonymised or pseudonymised data
Intended Users:
Chief Investigators submitting studies for UCL/UCLH sponsorship
Version:
1.0
Date of Version:
06/01/2021
Regulatory Compliance:
Health Research Authority (HRA) guidance, Research Ethics Committee requirements, UK Data Protection Act 2018, GDPR 2016/679
Context:
Guidance on preparing, formatting, and submitting protocols for data-only studies under UCL/UCLH sponsorship, including required declarations and version tracking.
Year:
2026
Region / City:
London
Subject:
Clinical Research Protocol
Document Type:
Template
Institution:
University College London Hospitals NHS Foundation Trust (UCLH)
Author:
UCLH Research Office
Target Audience:
UCLH Investigators, Clinical Researchers
Study Duration:
Ongoing
Approval Date:
Not specified
Date of Modification:
Not specified
Year:
2018
Region / city:
United States
Topic:
Clinical Research / Observational Studies
Document type:
Template
Organization:
National Institute for Dental and Craniofacial Research (NIDCR)
Author:
N/A
Target audience:
Principal Investigators and Study Staff
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2012
Region / City:
N/A
Theme:
Medical Outcomes Research
Document Type:
Technical Specifications
Organization / Institution:
Foundation for the National Institutes of Health (FNIH)
Author:
Patrick Ryan, Christian Reich, Mark Khayter
Target Audience:
Researchers, healthcare professionals, organizations working in medical outcomes research
Period of Validity:
N/A
Approval Date:
March 9, 2012
Date of Changes:
N/A
Year:
2022
Region / City:
Boston, MA, USA; Rio de Janeiro, Brazil; Providence, RI, USA
Topic:
Dental implants, occlusal contact, pressure-sensitive indicators
Document type:
Clinical study
Institution / Organization:
Harvard School of Dental Medicine, University of The State of Rio de Janeiro, Johnson and Wales University
Author:
Philip Millstein, Carlos E. Sabrosa, Wai Yung
Target audience:
Dental professionals, researchers in restorative dentistry
Period of validity:
Not specified
Approval date:
December 08, 2022
Date of changes:
Not specified
Year:
2026
Region / City:
Not specified
Topic:
Cancer, Parenteral nutrition, Fatigue, Physical function
Document type:
Case report
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Healthcare professionals, researchers
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Document Type:
Protocol Template
Research Category:
Observational Research
Intervention Type:
Non-Therapeutic Interventions
Oversight Body:
Colorado Multiple Institutional Review Board (COMIRB)
Institution:
University of Colorado Denver
Review Authority:
Institutional Review Board (IRB)
Required Fields:
Study Title; Protocol (COMIRB) Number; Principal Investigator; Version Number; Version Date; Sponsor
Sections Included:
Study Rationale; Background; Objectives; Study Design; Study Population; Recruitment and Retention; Study Assessments and Procedures; Risk/Benefit Assessment; Unanticipated Problems; Data Analysis; Future Research of Stored Specimens
Reporting Requirement:
Unanticipated Problems reported within 5 working days to IRB
Contact:
[email protected]
Year:
2018
Region / City:
Barcelona, Spain
Topic:
Endoscopic mucosal resection, Colonoscopy, Narrow band imaging
Document Type:
Research article
Organization / Institution:
Hospital del Mar, Barcelona
Author:
Fausto Riu Pons, Montserrat Andreu, Javier Gimeno Beltran, Marco Antonio Álvarez-Gonzalez, Agustín Seoane Urgorri, Josep Maria Dedeu, Luis Barranco Priego, Xavier Bessa
Target Audience:
Medical professionals, Gastroenterologists
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Title:
Supplement to “Broadening the Berlin Definition of ARDS to Patients Receiving High–flow Nasal Oxygen”
Study type:
Observational study
Document type:
Supplement including statistical analysis plan, tables and figures
Study population:
Patients with acute hypoxemic respiratory failure due to COVID–19
Clinical focus:
Acute respiratory distress syndrome according to the Berlin definition
Interventions compared:
High–flow nasal oxygen and invasive ventilation
Severity classification:
Mild, moderate and severe ARDS
Outcomes reported:
ICU discharge, hospital discharge, 28–day mortality, 90–day all–cause mortality
Statistical methods:
Hazard ratios with centre as random effect
Corresponding author:
Fleur–Stefanie L.I.M. van der Ven
Institution:
Department of Intensive Care, Amsterdam University Medical Centers, location ‘AMC’
Country:
The Netherlands
Collaborating group:
PRoAcT–COVID study investigators
Year:
2018
Region / City:
Michigan, USA
Subject:
Astronomy
Document Type:
Syllabus
Institution:
Northern Michigan University
Professor:
Dr. David W. Donovan
Target Audience:
Students of AS 103 course
Duration:
Fall 2018
Approval Date:
Not specified
Change Date:
Not specified
Year:
2022
Region / City:
NHS Tayside
Topic:
Liver disease detection, Malignancy detection
Document Type:
Retrospective Observational Cohort Study
Institution:
NHS Tayside
Author:
Not specified
Target Audience:
Clinicians, Medical researchers
Period of Effect:
April 2022 – July 2024
Date of Approval:
Not specified
Date of Changes:
Not specified
Country:
Slovakia
Institution:
Slovak Hydrometeorological Institute (SHMU)
Thematic area:
Stratospheric ozone layer and UV radiation monitoring
Type of document:
National observational and research report
Observation period:
1961–2019
Main monitoring station:
Aerological and Solar Radiation Measurement Centre Poprad-Gánovce
Coordinates:
49.03 N, 20.32 E
Altitude:
706 m a.s.l.
Measured parameters:
Total column ozone, vertical ozone distribution, UV irradiance, aerosol optical depth, upper-air temperature, pressure, wind, humidity, ground ozone concentration
Instruments:
Brewer spectrophotometers MKIV #097 and MKIII #225, broadband UV radiometers SL 501 and KZ UV S-E-T, sun photometer
International programmes:
WMO GAW GO3OS, WOUDC, EUBREWNET, EUVDB EDUCE, NOAA AERONET, ACTRIS
Calibration traceability:
Environment Canada world reference triad, PTB reference, PMOD WRC
Research projects:
The Development and Spatial Data Processing Technologies of Climate System (ITMS:26220220102, 2010–2016); SHMU Project 2014-91
Data dissemination:
Daily TOC and UVI publication via SHMU website and reporting to international databases
Year:
2024
Region / City:
Conyers, Georgia
Topic:
Atmospheric Chemistry, Industrial Emissions
Document Type:
Dataset
Institution:
Georgia Institute of Technology
Author:
Dr. L. Gregory Huey
Target Audience:
Researchers, Environmental Scientists, Public Health Officials
Period of Validity:
October 2 - October 16, 2024
Approval Date:
January 29, 2026
Date of Modifications:
N/A
Year:
2011
Region / City:
Not specified
Topic:
Lunar Studies, Astronomy
Document Type:
Educational Curriculum
Organization:
Not specified
Author:
Christine Shupla, Alexandra Andrea Jones, LPA Goddard, Brian Grigsby
Target Audience:
Students, Educators
Duration:
Not specified
Approval Date:
Not specified
Revision Date:
Not specified
Keywords:
Lunar geology, Moon phases, Astronomy, Seismic data, Remote sensing, Student research
Document Type:
Research protocol template
Version:
April 22, 2020
Subject Area:
Prospective observational research
Applicable Study Designs:
Cohort, case-control, cross-sectional, descriptive, educational initiatives / interventions
Purpose:
Guidance for drafting a comprehensive prospective observational study protocol
Intended Users:
Investigators conducting prospective observational research
Institutional Context:
SickKids Clinical Research Services
Related Resources:
SPRINT: Streamlined Pathway for Research Initiation; Consent for Non-Interventional/Observational Studies - Parent (v.Nov 2019); Prospective Studies Main Application Checklist (v.Apr 2019)
Version Control Requirement:
Header date update required with each revision
Instructions Included:
Formatting guidance, example text, section deletion guidance, table of contents update instructions
Year:
20__
Note:
Region/City
Document Type:
Project Study Report
Year:
2026
Region / City:
London
Subject:
Clinical Research Protocol
Document Type:
Template
Institution:
University College London Hospitals NHS Foundation Trust (UCLH)
Author:
UCLH Research Office
Target Audience:
UCLH Investigators, Clinical Researchers
Study Duration:
Ongoing
Approval Date:
Not specified
Date of Modification:
Not specified
Note:
Year
Note:
Year
Subject:
Data Protection, GDPR Compliance
Document Type:
Agreement, Data Processing Agreement
Target Audience:
Participating NHS / HSC Organisations, Sponsors
Contextual description:
Data processing agreement for non-commercial research studies between Sponsor and Participating NHS / HSC Organisation.