№ files_lp_3_process_7_095658
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Statement template defining the sponsor’s declaration regarding the use or non-use of the Belgian Model Informed Consent Form in a clinical trial application for investigational vaccine studies involving adult healthy volunteers.
Document type:
Sponsor statement template
Subject:
Use of Belgian Model Informed Consent Form for vaccine trials in adult healthy volunteers
Related procedure:
Clinical trial application
Scope:
Interventional trials with investigational vaccines
Geographical reference:
Belgium
Applicable to:
Sponsors of clinical trials
Referenced document:
Belgian Model ICF for Vaccine Trials in Adult Healthy Volunteers
Required information:
EU number, trial number, sponsor details, adaptations to mandatory text if applicable
Signature requirement:
Sponsor representative in the Member State
Date format:
DD/MMM/YYYY
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
Global
Topic:
Coaching, ICF Credentialing
Document Type:
Exam Format
Organization:
International Coach Federation (ICF)
Author:
International Coach Federation (ICF)
Target Audience:
Coaching professionals pursuing ICF certification
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Document type:
Guidance document
Subject:
Informed consent in interventional clinical trials
Population:
Healthy adult participants
Scope:
Interventional clinical trials with trial medicine
Jurisdiction:
Belgium
Organizations mentioned:
CT College; Healixia; Ethics Committees; Belgian Data Protection Authority
Language versions:
English; French; Dutch
Intended users:
Clinical trial sponsors
Regulatory context:
Ethics Committee submission requirements
Version:
1.0
Year:
2023
Region / City:
Global
Topic:
Credentialing, Coaching, Exam Format
Document Type:
Official Announcement
Organization / Institution:
International Coaching Federation (ICF)
Author:
ICF
Target Audience:
Coaching professionals, Credentialing candidates
Effective Date:
February 1, 2023
Scheduled Break Start Date:
February 1, 2023
Change Date:
February 1, 2023
Year:
2021
Region / city:
Global
Topic:
Clinical Decision Making, Physical Therapy
Document Type:
Guide
Author:
Not specified
Target Audience:
Students, Healthcare Professionals
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Organization:
International Coaching Federation (ICF)
Document Type:
Sample Agreement
Subject:
Professional Coaching Services
Parties:
Coach; Company Client; Employee Client
Referenced Standard:
ICF Code of Ethics
Effective Date:
To be specified
Jurisdiction:
Not specified
Purpose:
Provision of professional coaching services to selected company employees
Liability Statement:
Disclaimer of warranties and limitation of liability by ICF
Termination:
Subject to terms specified within the Agreement
Confidentiality:
Protection of Employee Client confidentiality and coaching communications
Year:
2026
Region / City:
United States
Topic:
Tax Credit, Employment, Certification
Document Type:
Government Form
Organization:
U.S. Department of Labor, Employment and Training Administration
Author:
U.S. Department of Labor
Target Audience:
Employers, Job Applicants, State Workforce Agencies
Effective Period:
Until March 31, 2026
Approval Date:
Not specified
Revision Date:
Not specified
Document type:
Supplementary table
Subject:
Mapping of ICF categories to Target Outcomes and questionnaires
Classification system:
International Classification of Functioning, Disability and Health (ICF)
Components covered:
Body Function; Activities and Participation
ICF chapters:
b1 Mental functions; b2 Sensory functions and pain; d1 Learning and applying knowledge; d2 General tasks and demands; d3 Communication; d4 Mobility; d5 Self-care; d6 Domestic life; d7 Interpersonal interactions and relationships; d8 Major life areas; d9 Community, social and civic life
Levels included:
Level 2; Level 3–4
Additional section:
Neuropsychological assessment
Source reference:
WHO ICF Browser (https://apps.who.int/classifications/icfbrowser/
Note:
)
Note:
EU number
Sponsor(s) of the trial:
Name and address of the company, hospital, university or other organisation
Date:
DD/MMM/YYYY
Year:
24
Region / city:
Not specified
Field:
Health and Wellness Coaching
Document type:
Academic Program Requirements
Organization:
Notre Dame of Maryland University
Author:
Not specified
Target audience:
Students enrolled in the Master of Arts in Health and Wellness Coaching
Duration:
Three semesters
Approval date:
Not specified
Modification date:
Not specified
Year:
2018
Region / city:
Vale of York, Scarborough and Ryedale
Theme:
Varicose Veins Management
Document type:
Commissioning Policy
Organization:
NHS Vale of York and Scarborough and Ryedale CCGs
Author:
Not specified
Target audience:
Healthcare professionals, Primary care clinicians, Vascular surgeons
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
2018
Document type:
Guidance document
Subject:
Informed consent in interventional clinical trials
Population:
Healthy adult participants
Scope:
Interventional clinical trials with trial medicine
Jurisdiction:
Belgium
Organizations mentioned:
CT College; Healixia; Ethics Committees; Belgian Data Protection Authority
Language versions:
English; French; Dutch
Intended users:
Clinical trial sponsors
Regulatory context:
Ethics Committee submission requirements
Version:
1.0
Year:
2024
Region / City:
Ireland
Topic:
Clinical Trials, Legal Agreements, Healthcare
Document Type:
Explanatory Note
Organization:
HSE, IPHA
Target Audience:
Contract Research Organizations, Hospitals, Pharmaceutical Companies
Effective Date:
20.05.24
Related Date:
20.05.24
Approval Date:
20.05.24
Year:
2021
Region / City:
Brussels
Topic:
Clinical Research Ethics
Document Type:
Submission Form
Institution:
Saint-Luc University Clinics (CUSL)
Author:
Ethics Committee
Target Audience:
Researchers, Clinical Trial Investigators
Period of Validity:
2021-2022
Approval Date:
N/A
Date of Changes:
N/A
Year:
2019
Region / City:
Toronto, Canada
Topic:
Informed consent, Clinical trial
Document Type:
Template, Informed consent form
Institution:
SickKids
Author:
SickKids REB
Target Audience:
Parents, Researchers
Effective Period:
N/A
Approval Date:
November 14, 2019
Modification Date:
N/A
Year:
2019
Region / City:
SickKids, Canada
Topic:
Clinical Trial Consent Form
Document Type:
Template
Organization:
SickKids Research Ethics Board
Author:
SickKids
Target Audience:
Research Teams, Clinical Trial Participants
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
Spring 2009
Region / City:
Dartmouth-Hitchcock Medical Center
Subject:
Interventional Radiology Procedures
Document Type:
Clinical Manual
Institution:
Dartmouth-Hitchcock Medical Center
Author:
Not specified
Target Audience:
Medical professionals in interventional radiology
Effective Period:
Ongoing for clinical rotations
Approval Date:
Spring 2009
Date of Last Revision:
Not specified
Year:
2024
Region / City:
United Kingdom
Topic:
Health Technology Evaluation
Document Type:
Meeting Minutes
Organ / Institution:
National Institute for Health and Care Excellence (NICE)
Author:
Committee members and NICE staff
Target Audience:
Healthcare professionals, policy makers, and stakeholders in health technology evaluation
Period of validity:
10 October 2024
Approval Date:
10 October 2024
Date of Changes:
None