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These protocols describe a series of clinical trials conducted by KCPP in collaboration with AARA Clinical Research to evaluate various treatments for rheumatoid arthritis, psoriatic arthritis, and other autoimmune diseases.
Note:
Year
Region / City:
Northland
Theme:
Rheumatology, Clinical Trials
Document Type:
Clinical Trial Protocols
Institution:
KCPP
Author:
Micah Judd, Naishi Kachadiya
Target Audience:
Healthcare Providers, Researchers, Clinical Trial Coordinators
Period of Validity:
Ongoing
Study Type:
Randomized, Double-blind, Placebo-controlled
Interventions:
Rinvoq, Taltz, Zepbound, Dazodalibep, Guselkumab
Study Purpose:
Evaluation of treatments for rheumatoid arthritis, psoriatic arthritis, lupus, Sjogren’s syndrome
Study Design:
Parallel-arm, Open Label, Biospecimen Collection, Registry Trial
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Year:
Not specified
Region / City:
Not specified
Topic:
Author disclosure, conflicts of interest
Document type:
Author disclosure form
Organization / Institution:
Rheumatology
Author:
Not specified
Target audience:
Authors of manuscripts submitted to Rheumatology
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Institution:
University of Colorado, Anschutz Medical Campus
Department:
Division of Rheumatology
Document Type:
Onboarding Letter
Authors:
Rachael Fuhrman, Jason R. Kolfenbach, M.D.
Target Audience:
Incoming Rheumatology Fellows
Associated Locations:
VA Medical Center, Denver Health, UCHealth
Due Dates:
Various (April 5th, April 12th, May 1st, June 11th, July 31st)
Related Systems:
OneDrive, Docusign, MedHub
Training Requirements:
VHA Mandatory Training, local policy acknowledgements, orientation handbooks
Context:
Official onboarding correspondence outlining required actions, deadlines, and document submissions for new rheumatology fellows at a university-affiliated medical program.
Year:
2026
Region / City:
Scotland
Topic:
Paediatric Rheumatology, Iloprost Treatment
Document Type:
Medical Guideline
Author:
Scottish Paediatric & Adolescent Rheumatology Network
Target Audience:
Healthcare professionals involved in paediatric rheumatology
Period of Validity:
June 2026
Approval Date:
June 2026
Date of Changes:
N/A
Year:
2023
Region / City:
Tallaght
Subject:
Rheumatology Patient Queries
Document Type:
Form
Organization / Institution:
Tallaght University Hospital
Author:
Tallaght University Hospital
Target Audience:
Patients of Tallaght University Hospital
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2025
Region / city:
UK
Topic:
Rheumatology, Axial Spondyloarthritis
Document type:
Guideline
Organization / institution:
British Society for Rheumatology
Author:
Sizheng Steven Zhao, Stephanie R Harrison, Ben Thompson, Max Yates, Joe Eddison, Antoni Chan, Nick Clarke, Nadia Corp, Charlotte Davis, Lambert Felix, Kalveer Flora, William J Gregory, Gareth T Jones, Christopher A Lamb, Helena Marzo-Ortega, Daniel J Murphy, Harry Petrushkin, Virinderjit Sandhu, Raj Sengupta, Stefan Siebert, Danielle A Van Der Windt, Dale Webb, Zenas Z N Yiu, Karl Gaffney
Target audience:
Health professionals, rheumatologists
Period of validity:
Ongoing
Approval date:
2025
Date of changes:
Not specified
Context:
This is a clinical guideline for treating axial spondyloarthritis with biologic and targeted synthetic DMARDs.
Year:
2026
Region / City:
Worcestershire, UK
Topic:
Medical Referral Form
Document Type:
Referral Form
Institution:
Worcestershire Acute Hospitals NHS Trust
Author:
Not specified
Target Audience:
Healthcare professionals
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / city:
Liverpool
Topic:
Clinical psychology resources for children and young people with rheumatological conditions
Document type:
Leaflet
Organization:
Alder Hey Children’s NHS Foundation Trust
Author:
Sally Bell & Marilena Hadjittofi
Target audience:
Children, young people, and their families dealing with rheumatological conditions
Period of validity:
Until May 2026
Date of approval:
May 2026
Date of revisions:
None stated
Year:
2024
Region / City:
Pretoria
Subject:
Court Schedules
Document Type:
Court Listing
Institution:
Gauteng Division, Pretoria
Target Audience:
Legal professionals, Court staff
Period of Validity:
20 February 2024
Approval Date:
20 February 2024
Date of Changes:
N/A
Jurisdiction:
Australia
Regulatory framework:
Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme
Document type:
Regulatory notification form
Scope:
Clinical trials involving medicines, biologicals, medical and therapeutic devices
Trial phases covered:
Phase I–IV, bioavailability/bioequivalence, device studies
Subjects:
Human participants
Ethics oversight:
Human Research Ethics Committee (HREC)
Approving authority:
Relevant institutional authority
Geographic coverage:
Australian trial sites with optional international sites
Responsible party:
Lead Investigator
Fee responsibility:
Lead Investigator
Related institution:
La Trobe University
Submission requirement:
Completed form and ethics approval
Note:
Year
Subject:
Clinical Trials, Medical Research
Document Type:
Template
Organization / Institution:
EU Clinical Trials Expert Group
Target Audience:
Sponsors of clinical trials
Document type:
Instructional guidance
Subject:
Informed consent forms in clinical research
Context:
Clinical trials involving human participants
Regulatory and ethical framework:
Research ethics and regulatory compliance
Organizations referenced:
Children’s Oncology Group; National Cancer Institute; National Institutes of Health; OCREB
Funding context:
Public funding by the National Cancer Institute
Intended audience:
Consent form authors; clinical trial investigators; participating centres
Geographic scope:
North America
Population referenced:
Children and adolescents with cancer; parents or legal guardians
Related materials:
Provincial informed consent form templates; lay terminology glossary
Year:
2025
Region / city:
Ireland
Topic:
Clinical trials, Primary care, Research funding
Document type:
Request Form
Organization / institution:
Health Research Board
Author:
HRB Primary Care Clinical Trials Network
Target audience:
Lead Investigators in clinical trials
Effective period:
Until November 2026
Approval date:
N/A
Date of amendments:
N/A
Year:
2024
Region / City:
N/A
Topic:
Critical Appraisal
Document Type:
Checklist
Organization / Institution:
Critical Appraisal Skills Programme (CASP)
Author:
Critical Appraisal Skills Programme (CASP)
Target Audience:
Healthcare professionals, researchers
Date of Approval:
N/A
Date of Modification:
N/A
Note:
Year
Document type:
Template
Institution / organization:
EU Clinical Trials Expert Group
Target audience:
Sponsors of clinical trials
Year:
2023
Region / City:
Rwanda
Theme:
Clinical Trials, Good Clinical Practice (GCP) Inspection
Document Type:
Guidelines
Organization / Institution:
Rwanda Food and Drugs Authority (Rwanda FDA)
Author:
Dr. Emile BIENVENU
Target Audience:
Clinical trial regulators, researchers, pharmaceutical professionals
Period of Validity:
Starting from 23/07/2021
Approval Date:
20/05/2021
Date of Revision:
06/01/2023
Year:
2018
Region / City:
Melbourne
Subject:
Clinical Trials, Monitoring, Investigator-Initiated Trials
Document Type:
Template
Organization / Institution:
Melbourne Children’s Trials Centre, Clinical Research Development Office (CRDO)
Author:
Not specified
Target Audience:
Sponsor-Investigators, Clinical Research Professionals
Effective Period:
Not specified
Approval Date:
01 May 2018
Date of Changes:
Not specified
Note:
Year
Subject:
Clinical Trials, FDA, NIH, IND, IDE
Document Type:
Template
Organization / Institution:
National Institutes of Health (NIH)
Target Audience:
Clinical Researchers, Investigators
Document type:
Application form
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Country:
South Africa
Subject:
Additions and/or changes in investigators and clinical trial sites
Document number:
GLF-CEM-CT-01D
Related form:
CTF3
Version:
v4
Date of first approval:
October 2019
Date of latest update:
September 2022
Update history:
October 2019 first version approved; March 2020 administrative changes; September 2022 administrative changes, checklist update, appendix removal, document number change
Applicable actions:
Additional investigator(s); Change of investigator(s); Additional site(s); Change in site location
Required attachments:
Cover letter; Investigator documents; Site staff documents; Proof of payment
Approval bodies referenced:
Ethics Committee(s)
Intended applicant:
Sponsor, CRO, or local sponsor company
Regulated area:
Clinical trials
Organization:
Joanna Briggs Institute (JBI)
Document type:
Critical appraisal tool / checklist
Topic:
Randomized controlled trials (RCTs)
Target audience:
Researchers conducting systematic reviews
Year:
2020
Source:
JBI Manual for Evidence Synthesis
Format:
Checklist for individual participants in parallel group RCTs
Purpose:
Assess methodological quality and risk of bias in RCTs
Reference:
Tufanaru C, Munn Z, Aromataris E, Campbell J, Hopp L. Chapter 3: Systematic reviews of effectiveness
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.