№ files_lp_4_process_1_39489
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Detailed procedure document outlining the review process for notifications of emergency use of drugs, biologics, or devices, compassionate use of unapproved medical devices, and non-emergency investigational drug access with IRB waiver, specifying responsibilities, workflow, and regulatory compliance.
Year:
2025
Organization:
West Virginia University Office of Human Research Protections (WVU OHRP)
Document Type:
Standard Operating Procedure (SOP)
Approver:
WVU Vice President of Research
Owner:
WVU OHRP Director
Purpose:
Review of emergency use of drugs, biologics, or devices, compassionate use of unapproved devices, and IRB waiver requests for investigational drugs
Scope:
Physicians, IRB staff, Designated Reviewers
Revision History:
None
Materials Referenced:
HRP-024 SOP, HRP-314 Worksheet, HRP-322 Worksheet, HRP-325 Worksheet
Regulatory References:
21 CFR § 50.23; 21 CFR § 50.24; 21 CFR § 56.102(d); 21 CFR § 56.104(c); 21 CFR § 312.305; 21 CFR § 812.36; 21 CFR § 812.47; 21 CFR § 56.105; 21 CFR § 56.108(c)
Effective Date:
12/15/2025
Price: 8 / 10 USD
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Year:
2025
Organization:
West Virginia University
Department:
Office of Human Research Protections (OHRP)
Document type:
Standard Operating Procedure (SOP)
Owner:
WVU OHRP Director
Approver:
WVU Vice President of Research
Purpose:
Removal and deregistration of Institutional Review Boards (IRBs)
Applicable regulations:
45 CFR §46.107, 45 CFR §46.103(b)(3), 45 CFR §46.115(a)(5), 21 CFR §56.107, 21 CFR §56.115(a)(5)
References:
AAHRPP elements II.1.A, II.1.C
Procedures:
Internal and external IRB removal steps, member notifications, database updates
Year:
2014
Country:
Belgium
Legislation:
Royal Decree of 14/12/2006 as amended by Royal Decree of 25/04/2014
Type of document:
Regulatory guidance
Target audience:
Pharmaceutical companies, healthcare professionals
Subject:
Compassionate use programs and medical need programs
Procedures included:
Submission process, dossier requirements, publication information, labeling, pharmacovigilance
Reference:
Regulation 726/2004, Article 6
Year:
2022
Region / City:
Not specified
Topic:
Compassionate love, family dynamics, psychological studies
Document Type:
Supplemental materials
Author:
Not specified
Target Audience:
Researchers in psychology, particularly those studying family relationships and compassionate love
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Study 1:
Parents of children under the age of 18
Study 2:
Parents of adult children (over 18 years)
Study 3:
Not specified
Study 4:
Focus on mothers of different ages
Study 7:
Replication of previous study by Collins et al. (2014)
Methodology:
Surveys, scales (Compassionate Love Scale)
Study Sample Size:
Study 1 - ~200 participants, Study 2 - ~200 participants, Study 4 - 555 participants
Compassionate Love Scale:
6-item and 21-item versions used
Access to Data:
Available on Open Science Framework
Study Details:
Detailed education and income descriptors for studies 1 and 2 provided
Description:
Supplementary materials for studies on compassionate love and beneficence within family dynamics, including sample size considerations, scales used, and demographic data.
Year:
2020
Region / city:
Africa
Topic:
Compassionate use of investigational medicinal products
Document type:
Guideline
Institution:
African Vaccine Regulatory Forum (AVAREF)
Author:
AVAREF
Target audience:
National regulatory authorities, public health organizations, medical professionals
Effective period:
Ongoing
Approval date:
February 2021
Modification date:
N/A
Year:
2020
Region / City:
Africa
Topic:
Compassionate Use of Medicines
Document Type:
Guidance
Organization / Institution:
African Vaccine Regulatory Forum (AVAREF)
Author:
AVAREF
Target Audience:
Regulatory Authorities, Health Organizations
Validity Period:
N/A
Approval Date:
June 15, 2020
Amendment Date:
July 24, 2020
Year:
2024
Region / City:
Belgium
Topic:
Compassionate use programs, medical need programs
Document Type:
Guidance
Organization / Institution:
FAMHP (Federal Agency for Medicines and Health Products)
Author:
FAMHP
Target Audience:
Medical professionals, pharmaceutical companies, regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Context:
This document provides guidelines for the application processes and requirements for compassionate use and medical need programs in Belgium, outlining submission formats, necessary documentation, and approval procedures.
Note:
Year
Theme:
Mental Health / Compassionate Mind Training
Document Type:
Handout
Organization:
Compassionate Mind
Target Audience:
Individuals, Clients, Mental Health Professionals
Location:
Anglesey (Ynys Môn)
Region:
Wales
Country:
United Kingdom
Language:
English
Type of document:
Interview transcript
Format:
Time-coded video transcript
Main topic:
Council leadership strategy and organizational culture
Key themes:
Compassionate leadership, learning culture, staff wellbeing, performance review, service delivery to children and families
Institutions mentioned:
Local council on Anglesey
Target group:
Council staff, children and families on Anglesey
Time frame referenced:
Several years of implementation
Indicators mentioned:
Staff sickness reduction, decreased reliance on agency staff, lower staff turnover, improved consistency of practice
Year:
2026
Region / Country:
Wales
Organisation:
Mindfulness Wales / Meddylgarwch Cymru
Course title:
Compassionate Mind Training (CMT) for Adults
Format:
Online via Zoom
Duration:
Six sessions
Session dates:
3, 10, 24 February; 3, 10, 17 March 2026
Session time:
4pm–5.30pm
Session length:
90 minutes
Target audience:
Adults, including school staff and professionals in Wales
Cost:
No charge
Research partner:
University of Derby
Research component:
Participation includes completion of online research questionnaires
Contact persons:
Liz Williams; Matt Jones
Publication date:
5 January 2026
Year:
2025
Region / City:
N/A
Topic:
Medical Device, Compassionate Use
Document Type:
Worksheet
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Investigators, Designated Reviewers
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2026
Event Date:
October 15–16, 2026
Location:
DoubleTree by Hilton San Jose, California, USA
Organization:
Coalition for Compassionate Care of California (CCCC)
Document Type:
Call for Poster Submissions
Target Audience:
Health professionals, researchers, educators
Submission Deadline:
March 24, 2026
Conference Theme:
Foundations & Futures
Focus Areas:
Palliative care, advance care planning, serious illness care, healthcare innovation
Poster Requirements:
Abstract up to 250 words, poster display 40” X 60”, one presenter per poster
Registration Policy:
Presenter must register for the conference; $50 discount available; presenters cover own expenses
Contact:
Kristine Wallach, [email protected], 916-779-7501
Year:
2020
Region:
District of Columbia, USA
Topic:
Criminal justice / Prisoner rights
Document type:
Report / Update
Organization:
District of Columbia Corrections Information Council
Collaborating organizations:
Washington Lawyers’ Committee, Public Defender Service of DC, National Association of Criminal Defense Lawyers
Audience:
DC Code Offenders, legal professionals
Number of cases filed:
248
Number of cases decided:
104
Number of compassionate releases granted:
29
Contact emails:
[email protected]
Contact phone:
202-319-1074
Summary:
Report detailing the implementation and outcomes of compassionate release legislation under DC Code 24-403.04, including case statistics and support organizations involved.
Year:
2026
Region:
Not specified
Subject:
Employment Rights / Leave Policies
Document Type:
Policy Attachment
Organization:
Employer / Human Resources Department
Audience:
Employees
Applicability Period:
Ongoing
Related Legislation:
Fair Work Act (FW Act)
Leave Entitlement:
2 days per permissible occasion
Eligible Relations:
Immediate family members, household members, spouse or de facto partner
Conditions:
Serious illness, injury, death, stillbirth, miscarriage
Leave Structure:
Single 2-day period, two separate 1-day periods, or agreed alternative periods
Notice and Evidence Requirements:
As per agreement or linked Personal/Carers Leave clauses
Year:
Not specified
Region / City:
Not specified
Theme:
Religious / Christian sermon
Document Type:
Sermon outline
Author:
Not specified
Target Audience:
Church congregation
Scripture Reference:
Mark 5:21-43
Main Focus:
Compassion and power of Jesus
Key Concepts:
Healing, faith, hope, redemption
Year:
2019
Region / City:
Suffolk
Topic:
Leadership, Workplace Behaviour, Staff Support
Document Type:
Action Plan
Organization:
West Suffolk NHS Foundation Trust (WSFT)
Author:
Not specified
Target Audience:
WSFT leaders, staff members
Period of Action:
From 19th June 2019 onwards
Approval Date:
Not specified
Date of Changes:
Not specified
Main Issues Addressed:
Bullying, harassment, unconscious bias
Key Actions:
Promote inclusivity, encourage reporting, training on unconscious bias, feedback techniques
Expected Outcome:
Improve staff experience, foster better work relationships, ensure safer work environment
Context:
The document is an action plan aimed at improving the work environment at WSFT by addressing bullying, harassment, and unconscious bias, with leadership promoting inclusivity, staff feedback, and effective communication strategies.