№ lp_2_3_37328
File format: docx
Character count: 113042
File size: 1536 KB
Protocol template for investigator-initiated clinical studies outlining study design, objectives, patient selection, treatment plans, dose adjustments, adverse event reporting, and appendices.
Year:
2018
Institution:
The George Washington University Cancer Center
Document Type:
Research Protocol Template
Study Phase:
Phase II
Principal Investigator:
Not specified
Co-Investigators:
Not specified
Statistician:
Not specified
Sponsor:
The George Washington University Cancer Center
Support/Grant:
Not specified
Supplied Agents:
Not specified
Other Agents:
Not specified
Study Number:
Assigned by GW Cancer Center
Location:
Washington, DC, USA
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024
Regulatory authority:
Therapeutic Goods Administration (TGA)
Medicine:
MACITENTAN 10 mg with TADALAFIL 40 mg (Opsynvi®)
Indication:
Pulmonary arterial hypertension (PAH), WHO Group 1, functional class II and III
Therapy type:
Dual or triple combination therapy
Dosage form:
Tablet, fixed dose combination (FDC)
Prescriber type:
Medical practitioners
Restriction type:
Authority Required (Written, Complex Authority Required)
Clinical criteria:
Treatment as dual therapy (MAC+TAD) or triple therapy with prostanoid
Population:
Adult patients with stable PAH on separate doses of macitentan and tadalafil
Previous considerations:
PBAC recommendations for macitentan and tadalafil since 2011–2014
Approval date:
16 September 2024
Source documents:
TGA registration, PBAC meeting minutes, ACM minutes August 2024, FDA, EMA, CDA references
Year:
2023
Region / city:
Australia
Topic:
Oncology, Pharmaceuticals
Document Type:
Resubmission
Institution:
Australian Government, Pharmaceutical Benefits Advisory Committee
Author:
AstraZeneca Pty Ltd.
Target Audience:
Healthcare professionals, regulatory bodies
Effective Period:
Ongoing
Approval Date:
November 2021
Date of Changes:
November 2021
Year:
2020
Region / City:
Elbonia
Meeting:
3GPP TSG-RAN WG2 #112
Document Type:
Technical report
Source / Organization:
Nokia, Nokia Shanghai Bell
Agenda Item:
5.4.3
Purpose:
Discussion and Decision
Scope:
Analysis of bandwidth combination sets (BWCS) for inter-ENDC and intra-ENDC configurations
Relevant Standards:
TS 38.101-1, TS 38.101-2, TS 38.101-3, TS 38.306
Deadline:
Short
Section:
26 13 13
Voltage class:
5 kV–15 kV
Document type:
Technical specification
Subject:
Medium-voltage switch-circuit breaker combination switchgear
Equipment type:
Metal-enclosed load-interrupter switchgear with vacuum circuit breakers
Applicable standards:
ANSI/IEEE C37 series; CSA 22.2 series; UL or C-UL listing
Frequency:
50 Hz; 60 Hz
System configuration:
Three-phase, grounded-neutral, ungrounded, or high-impedance grounded
Installation type:
Indoor or outdoor metal-enclosed switchgear
Manufacturer requirements:
Minimum five years experience; ISO 9001 or 9002 certification
Switchgear ratings:
Main bus up to 2000 A; short-time current up to 38 kA
Circuit breaker ratings:
5.0 kV and 15.0 kV classes with specified BIL and current ratings
Submittals required:
Shop drawings, wiring diagrams, schematics, bills of material, manuals
Construction requirements:
Factory-assembled metal-enclosed construction per IEEE C37.20.3
Storage and handling:
In accordance with manufacturer recommendations
Year:
2025
Region / City:
USA
Theme:
Reproductive Health, Contraception
Document Type:
Clinical Practice Standard
Agency / Institution:
(insert AGENCY name)
Author:
(insert AGENCY name)
Target Audience:
Healthcare providers (MDs, NPs, PAs, DOs, NDs, RNs)
Period of Action:
Ongoing
Approval Date:
January 2025
Revision Date:
March 2017, January 2018, January 2019, January 2021, October 2022, January 2025
Year:
2025
Region / City:
Australia
Topic:
Pharmaceutical benefits, chemotherapy, PBS
Document Type:
FAQ
Organization:
Pharmaceutical Benefits Scheme
Author:
Pharmaceutical Benefits Advisory Committee (PBAC)
Target Audience:
Healthcare providers, prescribers, patients
Effective Period:
From December 1, 2024
Approval Date:
Not specified
Modification Date:
Not specified
Contextual Description:
FAQ document providing detailed information on the changes in PBS listing for Opdualag and Vyxeos under the EFC Program, including prescription and claiming details.
Year:
2023
Region / City:
Global
Theme:
Assistive Technology, Braille Displays
Document Type:
User Manual
Organization:
APH (American Printing House for the Blind)
Author:
APH
Target Audience:
Users of iOS devices with braille needs
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Region / city:
Australia
Topic:
Therapeutic Goods Regulation
Document type:
Guidance
Organization:
Therapeutic Goods Administration (TGA)
Author:
Commonwealth of Australia
Target audience:
Sponsors, manufacturers, and regulatory professionals
Validity period:
Not specified
Approval date:
October 2022
Date of changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Cancer Treatment / Immunotherapy
Document Type:
Submission
Organ / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Bristol-Myers Squibb
Target Audience:
Medical professionals, healthcare policy makers, pharmaceutical industry stakeholders
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Subject:
Machine Learning, Ensemble Methods, Unsupervised Learning
Document Type:
Educational Unit / Lecture Notes
Author:
Not specified
Target Audience:
Students and researchers in machine learning
Techniques Covered:
Model combination, Voting schemes, Bagging, Boosting, Stacking, K-means clustering, K-nearest neighbors, Gaussian mixture models, Expectation maximization
Scope:
Theoretical explanation of ensemble learning and unsupervised methods, including algorithm generation and combination strategies
Year:
2024
Region / City:
United States
Topic:
Vaccination Protocol
Document Type:
Medical Protocol
Organization / Institution:
American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP)
Author:
Prescriber
Target Audience:
Healthcare professionals
Period of validity:
Indefinite until rescinded
Approval Date:
March 26, 2024
Date of changes:
Not specified
Year:
2023
Region / City:
East Lansing, Michigan
Subject:
Nuclear Physics, Bayesian Methods
Document Type:
Research Paper
Organization / Institution:
Facility for Rare Isotope Beams, Michigan State University, Department of Physics and Astronomy, Michigan State University
Authors:
Knight, Bailey, Lalit, Sudhanva, Godbey, Kyle, Giuliani, Pablo, Nazarewicz, Witold
Target Audience:
Nuclear physicists, researchers in astrophysics
Period of Effectiveness:
N/A
Approval Date:
N/A
Modification Date:
N/A
Contextual Description:
A research paper exploring the use of heteroscedastic uncertainties in Bayesian nuclear model combination, aiming to enhance predictive performance in nuclear physics models.
Year:
2022
Region / City:
N/A
Topic:
Fire & Smoke Damper Testing
Document Type:
Training Aid
Organization:
National Energy Management Institute Committee
Target Audience:
Contractors, Supervisors, Technicians, FLS Supervisors
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Applicable Standards:
NFPA 80 – 2022, NFPA 105 – 2012, NFPA 92 – 2018
Inspection Frequency:
Periodic
Document Purpose:
Guide for developing inspection methods and procedures for FLS dampers
Year:
2021
Organization:
European Commission
Service:
Service for Foreign Policy Instruments (FPI)
Programme:
European Peace Facility (EPF)
Type of document:
Call for expression of interest
Place of employment:
Brussels
Unit:
FPI.5
Job profiles:
Audit assistance; Legal advice including anti-fraud, data protection and access to documents
Grades:
FG III; FG IV
Number of posts:
2
Eligibility:
Contract agents in EU institutions; EPSO CAST reserve list or database candidates
Languages required:
English; French
Application deadline:
23/08/2021
Recruitment period:
From October 2021
Contract type:
Contract agent under Article 3b CEOS
Security requirement:
Security clearance up to SECRET UE/EU SECRET or willingness to undergo vetting
Contact:
[email protected]
Year:
2026
Region / City:
Missouri
Topic:
Hereditary Angioedema Treatment
Document Type:
Proposal
Institution:
MO HealthNet
Author:
MO HealthNet and Conduent
Target Audience:
Health professionals and stakeholders in the MO HealthNet program
Effective Period:
Starting from May 9, 2019
Approval Date:
January 20, 2026
Modification Date:
Not specified
Document Status:
Revision of Existing Criteria
Context:
A proposal outlining the preferred drug list and approval criteria for hereditary angioedema treatment agents within the MO HealthNet program.
Year:
2024
Note:
Region / city
Subject:
Adult with incapacity, Guardianship, Welfare, Property and Financial Affairs
Document type:
Practice Note
Target audience:
Legal professionals, Solicitors, Guardians, Welfare officers
Year:
2023
Region / city:
Massachusetts, USA
Topic:
TRAIN account setup and course registration guide
Document type:
User guide
Organization:
TRAIN
Author:
Not specified
Target audience:
Clerks and Burial Agents
Validity period:
Ongoing
Approval date:
Not specified
Modification date:
Not specified
Year:
2026
Region / City:
N/A
Topic:
Copilot Agents Voucher Service Agreement Verification
Document Type:
Instructional Guide
Organization / Institution:
Microsoft
Author:
N/A
Target Audience:
Partners, Customers
Effective Period:
N/A
Approval Date:
January 14, 2026
Modification Date:
N/A