№ lp_1_2_51805
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This document is a tool summary sheet designed for the preparation of DSMB reports, detailing structure, recommendations, and guidance on the necessary components and formatting for such reports.
Note:
Year
Target Audience:
Statisticians and Principal Investigators responsible for preparation of DSMB reports
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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
Year:
2019
Note:
Region / city
Topic:
Risk of bias assessment, randomized trials
Document type:
Template
Organization / institution:
Cochrane Collaboration
Author:
Julian PT Higgins, Jelena Savović, Matthew J Page, Jonathan AC Sterne
Target audience:
Researchers, clinicians, trialists
Year:
2020
Region / City:
South Australia
Topic:
Systematic Reviews, Critical Appraisal, Healthcare Research
Document Type:
Research Guideline
Institution:
University of Adelaide, JBI
Author:
Tufanaru C, Munn Z, Aromataris E, Campbell J, Hopp L
Target Audience:
Researchers, Healthcare Professionals
Period of Application:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2021
Region / City:
Seattle
Subject:
Oncology, Cardiology
Document Type:
Clinical Protocol
Author:
Kasey Leger, MD
Target Audience:
Medical Professionals, Researchers
Period of Validity:
Ongoing
Approval Date:
2021
Date of Last Update:
2021
Document type:
Supplementary materials
Study type:
Randomized controlled trial
Trial name:
iMODIPONV
Medical field:
Anesthesiology
Clinical focus:
Postoperative nausea and vomiting after hysterectomy
Primary variable:
Muscular tissue oxygen saturation
Population:
Posthysterectomy patients
Study design:
Multicenter
Participating institutions:
University and provincial hospitals
Countries involved:
China, United States
Committees:
Steering Committee, Quality Committee, Data Safety Monitoring Board
Data included:
Site investigators, coordinators, hospital participation, treatment assignment, randomization errors
Analyses:
Sensitivity analyses, multivariable logistic regression
Supplementary content:
Figures and tables
Source type:
Supplement to a peer-reviewed clinical trial publication
Year:
2023
Region / City:
Liege, Belgium
Field:
Anesthesia, Pharmacology
Document Type:
Clinical Trial Report
Institution:
Department of Anesthesia and Intensive Care Medicine, Liege University Hospital, Liege, Belgium
Authors:
G Van Munster, F Beck, PY Hardy, M Carella, V Bonhomme
Target Audience:
Medical professionals, researchers in anesthesia
Period of Study:
October 21, 2021 – April 8, 2022
Approval Date:
2021
Modification Date:
N/A
Funding:
Department of Anesthesia and Intensive Care Medicine, Liege University Hospital, Liege, Belgium
Ethics Approval:
Comité d’Ethique Hospitalo-Facultaire Universitaire de Liège (study number 2021/190)
Clinical Trial Registration:
EudraCT: 2021-002824-19
Methodology:
Randomized, Double-blind, Placebo-controlled
Conclusion:
MS does not effectively reduce propofol requirements for hypnosis in general anesthesia during thyroidectomy
Year:
2026
Region / city:
New York, NY
Topic:
Cardiovascular health, sedentary behavior
Document Type:
Research article
Organization / institution:
Columbia University Medical Center
Authors:
Andrea T. Duran, Ciaran P. Friel, Maria A. Serafini, Ipek Ensari, Ying Kuen Cheung, Keith M. Diaz
Target audience:
Researchers, healthcare professionals
Period of validity:
N/A
Approval date:
N/A
Modification date:
N/A
Year:
2023
Region:
China
Subject:
Male rectal cancer, laparoscopic surgery, postoperative urogenital function
Document Type:
Clinical trial protocol
Organization:
Sun Yat-sen University, Multiple affiliated hospitals
Author:
Research Team
Target Audience:
Medical professionals, researchers, clinicians
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2024
Region / City:
South-Eastern Norway
Subject:
Orthopaedics, Ankle Fractures, Surgery
Document Type:
Research Protocol
Institution:
Norwegian University of Science and Technology, Østfold Hospital Trust
Author:
Frede Jon Frihagen, Marius Molund, Esten Konstad Haanæs
Target Audience:
Medical professionals, researchers in orthopaedics
Period of Validity:
September 2024 - July 2032
Approval Date:
23rd of January 2025
Modification Date:
Not specified
Contextual Description:
Research protocol for a multicentre randomised controlled trial on the deltoid ligament repair in unstable ankle fractures, focusing on patient-reported outcomes and radiological stability.
Year:
2019
Region / city:
Cambridge, United Kingdom
Topic:
Hereditary diffuse gastric cancer, endoscopic surveillance, biopsy techniques
Document type:
Clinical Trial Study
Organization / institution:
University of Cambridge
Target audience:
Medical professionals, researchers, and clinicians involved in hereditary cancer surveillance
Period of action:
October 2017 - December 2018
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Multiple international locations
Topic:
Clinical trial, treatment for eosinophilic granulomatosis with polyangiitis
Document Type:
Research Article
Organization / Institution:
GlaxoSmithKline (GSK), National Institutes of Health (NIH), various academic institutions
Author:
Michael E. Wechsler, Praveen Akuthota, David Jayne, Paneez Khoury, Amy Klion, Carol A. Langford, Peter A. Merkel, Frank Moosig, Ulrich Specks, Maria C. Cid, Raashid Luqmani, Judith Brown, Stephen Mallett, Richard Philipson, Steve W. Yancey, Jonathan Steinfeld, Peter F. Weller, Gerald J. Gleich
Target Audience:
Medical professionals, researchers, healthcare providers
Period of Action:
52 weeks
Approval Date:
2023-01-01
Date of Revisions:
None
Year:
2023
Region / city:
New Zealand
Topic:
Vaccination and mortality data analysis
Document type:
Data analysis report
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, healthcare analysts, and data scientists
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Description:
The document provides a randomized dataset for analyzing vaccination records and associated mortality rates across various doses of the vaccine in New Zealand.
Note:
Year
Topic:
Prenatal Exercise, Maternal Health
Document Type:
Study Report
Year:
2026
Region / city:
Not specified
Subject:
Shoulder Impingement Syndrome, Physical Therapy, Manual Therapy
Document Type:
Clinical Trial
Organization / Institution:
Duke University School of Medicine
Author:
Kachingwe, A., Phillips, B., Sletten, E., & Plunkett, S.
Target Audience:
Healthcare professionals, physical therapists, researchers
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Date:
August 3, 2011
Author:
Lisa Hull
Document type:
Personal letter
Subject:
Support for Anna Stubblefield
Institutions mentioned:
Rutgers University; Essex County Superior Court
Individuals mentioned:
Anna Stubblefield; DMan; Judge Siobhan Teare
Location:
Newark, New Jersey
Related event:
Criminal trial beginning September 9, 2011
Purpose:
Request for awareness, attendance, and support
Funding information:
Defense fund contribution details
Communication medium:
Written correspondence
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
Topic:
Clinical Trials
Document Type:
Plan
Target Audience:
Study team, sponsors, and regulatory authorities
Year:
2014
Region / City:
Geneva
Topic:
Revision of TGP/8, DUS Trial Design and Data Analysis
Document Type:
Draft Document
Organization / Institution:
International Union for the Protection of New Varieties of Plants (UPOV)
Author:
UPOV Office
Target Audience:
Technical Committees, Working Parties for Vegetables, Agricultural Crops, Fruit Crops, Ornamental Plants, and others involved in plant variety protection
Period of Validity:
Ongoing (as of 2014)
Approval Date:
May 27, 2014
Date of Changes:
N/A
Note:
Year