№ lp_1_2_62274
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This document provides a template for planning and managing quality control and management activities in clinical trials, detailing processes for ensuring compliance with study protocols and regulatory standards.
Note:
Year
Document Type:
Template
Target Audience:
Research professionals, clinical trial personnel
Price: 8 / 10 USD
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Organization:
Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID)
Country:
United States
Document Type:
Instructional template and procedural guidance
Subject Area:
Clinical research quality management
Related Standards:
Good Clinical Practice (ICH E6(R2))
Associated Systems:
DMID CROMS (Clinical Research Operations and Management Support), NIAID Clinical Research Management System (N-CRMS)
Intended Users:
Clinical research sites conducting DMID-funded clinical studies or trials
Key Roles Mentioned:
Principal Investigator, DMID Clinical Project Manager (CPM)
Scope:
Development, implementation, and oversight of site Clinical Quality Management Plans
Lifecycle Coverage:
Protocol lifecycle from implementation to data review and documentation
Referenced Authorities:
U.S. Food and Drug Administration (FDA), International Council for Harmonisation (ICH)
Required Actions:
Version control, documentation review, quality control and quality assurance activities, signatures and filing of CQMP documents
Primary Components:
Protocol and site identification, quality control activities, quality assurance activities, roles and responsibilities, record selection, internal and external data sources
Year:
2024
Region / City:
European Union
Theme:
Health Technology Assessment
Document Type:
Guidance Document
Author:
HTA Coordination Group (HTACG)
Target Audience:
Health Technology Developers, Regulatory Authorities, Medical Researchers
Period of Validity:
Ongoing
Approval Date:
28 November 2024
Date of Last Change:
N/A
Context:
Guidance document for filling in the joint clinical assessment (JCA) dossier template for medicinal products, intended for use by health technology developers and regulatory bodies.
Year:
2026
Region / City:
Dobbs Ferry
Subject:
Occupational Therapy, Education
Document Type:
Program Curriculum
Institution:
Mercy University
Author:
Not specified
Target Audience:
Prospective students, applicants for Occupational Therapy Doctorate
Period of Validity:
Starting Fall 2026
Approval Date:
Not specified
Modification Date:
Not specified
Institution:
Rural Clinical School Research Centre
Document type:
Research proposal outline
Intended use:
Preliminary presentation of a research idea
Target audience:
Prospective clinical and health researchers
Scope:
Clinical and health research projects
Geographic context:
Australia
Recommended length:
Three to five pages
Required sections:
Title, Background, Aims, Research Question, Research Plan, Dissemination, Project Team, Budget, Timeframe, References
Disciplinary focus:
Medical and health sciences
Note:
Year
Topic:
Clinical Research, Retinal Diseases
Document Type:
Clinical Research Site Information
Organization / Institution:
Jaeb Center for Health Research (JCHR)
Target Audience:
Clinical researchers, Investigators, Healthcare professionals
Authors:
Brendan J. McMullan; Anita J. Campbell; Christopher C. Blyth; Jonathan C. McNeil; Christopher P. Montgomery; Steven Y. C. Tong; Asha C. Bowen
Type of document:
Narrative review article
Topic:
Pediatric Staphylococcus aureus bacteremia
Population:
Neonates, children and adolescents
Medical specialty:
Infectious Diseases
Methods:
Systematic appraisal of published literature
Data sources:
PubMed and Medline
Search period:
January 1960 – 31 December 2018
Geographic context:
High-income countries
Funding source:
No funding received
Conflict of interest:
None declared
Clinical scope:
Community-acquired and healthcare-associated bacteremia
Note:
Year
Year:
2023
Region / city:
Canberra
Topic:
Healthcare, Peritoneal Dialysis
Document Type:
Clinical Procedure
Organization / institution:
Canberra Health Services
Author:
Not specified
Target audience:
Healthcare staff, including Registered and Enrolled Nurses, Medical Officers, Consultants, Nephrology Advance Trainee Registrar (ATR), Students under direct supervision
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2026
Institution:
Nova Southeastern University, Ft. Lauderdale
Course:
Neuromuscular Systems II
Credits:
2
Duration:
12 weeks, first semester of third year
Contributors:
Suzana Simoes PT, DPT, NCS; Kim B. Smith PT, DPT; Jennifer Canbek, PT, PhD, NCS
Target audience:
Physical therapy students
Activity type:
Laboratory learning activity with volunteer patients
Focus:
Clinical decision making using ICF model for Parkinson’s disease
Learning objectives:
Assessment of PD cases, development of PT problem list, formulation of patient-centered plan of care, implementation of treatment interventions, evaluation of treatment outcomes
Materials:
Assigned readings from Schenkman & McCulloch (2002), Schenkman et al. (2010)
Methods:
Lab sessions with patient volunteers, outcome measures, treatment sessions, video documentation, SOAP note assignments
Assessment:
Rubric-based evaluation of outcome measures, ICF model application, problem list, plan of care, goals, treatment, and documentation
Year:
2021
Region / City:
Not specified
Topic:
Clinical practice guidelines, rehabilitation, stroke
Document Type:
Interview transcript
Organization / Institution:
Academy of Neurologic Physical Therapy, Jefferson College of Rehabilitation Sciences, Boston University
Authors:
Dr. Therese Johnston, Dr. Lisa Brown
Target Audience:
Clinicians, rehabilitation professionals, researchers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Region / City:
Canberra
Subject:
Female Genital Cutting (FGC), Clinical Guidelines, Healthcare
Document Type:
Clinical Guideline
Organization / Institution:
Canberra Health Services
Target Audience:
Healthcare staff (medical officers, nurse practitioners, registered nurses, midwives, allied health, students)
Contextual Description:
Clinical guideline outlining the management and prevention of female genital cutting (FGC) for healthcare providers at Canberra Health Services.
Year:
2004
Region / City:
USA
Subject:
Healthcare, Medical Software, Procedures
Document Type:
Technical Manual
Organization / Institution:
Department of Veterans Affairs
Author:
REDACTED
Target Audience:
Medical Professionals, IT Staff
Period of Validity:
Ongoing
Approval Date:
April 2004
Date of Changes:
December 2018
Year:
2022
Region / City:
Canberra
Subject:
Clinical Records Management
Document Type:
Procedure
Organization:
Canberra Health Services
Author:
Unknown
Target Audience:
CHS staff involved in clinical record management
Period of Validity:
Indefinite
Approval Date:
2022
Amendment Date:
2022
Year:
2016
Region / city:
Canberra
Subject:
Hip Fracture Care
Document Type:
Clinical Guideline
Organization:
Canberra Health Services
Author:
Australian Commission on Safety and Quality in Health Care
Target Audience:
Healthcare professionals involved in hip fracture management
Period of validity:
Not specified
Approval Date:
22 October 2021
Amendment Date:
Not specified
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
Region / City:
Bernalillo County
Theme:
Air Quality, Environmental Regulations
Document Type:
Application Form
Agency / Institution:
City of Albuquerque
Target Audience:
Facility owners, operators, and applicants for AQN
Certification:
Signed by responsible officer
Year:
2013
Jurisdiction:
Texas, USA
Topic:
Prescriptive authority delegation for nurse practitioners and physician assistants
Document type:
Guidance and form
Legal basis:
SB 406, 83rd Texas Legislature; Texas Occupations Code Section 157; Texas Administrative Code Chapter 193
Applicable settings:
All practice settings except facility-based practices (hospitals and long-term care facilities)
Requirements included:
Written agreement, signatures, license numbers, practice locations, drug categories, consultation and referral plan, emergency plan, communication plan, supervision delegation, quality assurance plan, periodic face-to-face meetings
Effective date:
November 1, 2013
Review period:
Initial 3 years monthly, then quarterly; exceptions for experienced NP/PAs with previous prescriptive authority
Year:
2023
Region / City:
Texas
Topic:
Backflow Prevention Assembly Test and Maintenance
Document Type:
Instruction Manual
Organization / Institution:
Texas Commission on Environmental Quality
Author:
Texas Commission on Environmental Quality
Target Audience:
Licensed testers, public water systems
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2026
Region / City:
United States
Subject:
Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) & Quality Reporting Program (QRP)
Document Type:
Supporting Statement
Agency:
Centers for Medicare & Medicaid Services (CMS)
Author:
U.S. Department of Health and Human Services
Target Audience:
Healthcare professionals, policymakers, and administrators in rehabilitation facilities
Effective Date:
October 1, 2026
Date of Approval:
Not specified
Date of Revision:
March 29, 2024
Expiration Date:
Not specified