№ lp_1_2_03491
File format: docx
Character count: 14030
File size: 44 KB
Structured guidance for preparing a clinical study’s data and safety monitoring plan, including definitions, reporting requirements, and procedural recommendations.
Note:
Year
Document Type:
Template and Guidelines
Sponsoring Institution:
National Institute on Aging (NIA)
Intended Use:
Clinical study planning
Target Audience:
Investigators conducting clinical trials
Content Focus:
Data and safety monitoring, adverse event reporting, interim analysis, participant protection
Study Phase:
Applicable to all behavioral and intervention studies
Sections Included:
Participant safety, interim analysis, data and safety monitoring, DSMB responsibilities, confidentiality protection
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:
Dana-Farber/Harvard Cancer Center
Theme:
Multi-center clinical trials, Data and Safety Monitoring
Document Type:
Template
Organization / Institution:
Dana-Farber/Harvard Cancer Center
Author:
DF/HCC
Target Audience:
Clinical trial administrators, coordinators, researchers
Period of validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2021
Region / Country:
Asia-Pacific
Topic:
Agricultural Development, Farmer Organizations
Document Type:
Program Implementation Call
Organization / Institution:
Asian Farmers Association for Sustainable Rural Development (AFA), La Via Campesina
Author:
AFA-LVC Consortium
Target Audience:
National Implementing Agencies, Farmer Organizations
Implementation Period:
2021–2026
Approval Date:
March 15, 2021
Document Revision Date:
Not specified
Year:
2023
Region / City:
Liverpool City Region
Topic:
Black Business Support
Document Type:
Survey
Author:
Gloria Hyatt, MBE
Target Audience:
Black business owners in the Liverpool City Region
Period:
Pilot Programme
Approval Date:
Not specified
Amendment Date:
Not specified
Context:
A survey focused on evaluating the business support available to Black entrepreneurs in Liverpool City Region, collecting demographic information, and providing feedback for improving services.
Year:
2025
Region / City:
Winston-Salem, NC
Theme:
Law, Health Policy, Bioethics
Document Type:
Academic CV
Institution:
Wake Forest University, Duke University, University of Pennsylvania
Author:
Nia M. Johnson
Target Audience:
Academic professionals, students in law, bioethics, health policy
Period of Activity:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
20__
Note:
Region/City
Document Type:
Project Study Report
Year:
2026
Region / City:
London
Subject:
Clinical Research Protocol
Document Type:
Template
Institution:
University College London Hospitals NHS Foundation Trust (UCLH)
Author:
UCLH Research Office
Target Audience:
UCLH Investigators, Clinical Researchers
Study Duration:
Ongoing
Approval Date:
Not specified
Date of Modification:
Not specified
Note:
Year
Note:
Year
Subject:
Data Protection, GDPR Compliance
Document Type:
Agreement, Data Processing Agreement
Target Audience:
Participating NHS / HSC Organisations, Sponsors
Contextual description:
Data processing agreement for non-commercial research studies between Sponsor and Participating NHS / HSC Organisation.
Year:
2024
Note:
Region / City
Theme:
Research Study Setup
Document Type:
Template
Target Audience:
Sponsor/Co-Sponsors, Participating NHS/HSC Organisations
Note:
Year
Year:
2016
Region / City:
Stafford, VA
Topic:
Science Education, Special Needs
Document Type:
Registration Form
Institution:
VSDB (Virginia School for the Deaf and the Blind)
Author:
Dr. Debbie Pfeiffer
Target Audience:
Families of students with hearing disabilities
Event Date:
Oct. 8, 2016
Date of Approval:
Not specified
Date of Changes:
Not specified
Year:
2016–
Country:
United States
Subject:
Compensation claims for victims of state sponsored terrorism
Document type:
Application instructions
Program:
U.S. Victims of State Sponsored Terrorism Fund
Administering authority:
U.S. Department of Justice
Legal basis:
Justice for United States Victims of State Sponsored Terrorism Act
Submission method:
Online claims portal
Language requirement:
English
Eligibility basis:
Final court judgment
Filing deadline rule:
90 days after final judgment
Privacy framework:
Privacy Act of 1974
Contact information included:
Yes
Year:
2024
Region / City:
Morgantown, West Virginia
Topic:
Occupational Safety and Health, Spirometry Training
Document Type:
Federal Regulation and Approval Request
Institution:
National Institute for Occupational Safety and Health
Author:
Kathleen Rogers, BS, RRT, CPFT
Target Audience:
Sponsors and applicants for NIOSH-approved spirometry training courses
Validity Period:
5 years (for course renewal)
Approval Date:
January 2, 2024
Date of Revisions:
None indicated
Note:
Year
Year:
2023
Region / City:
United Kingdom
Topic:
Clinical Research
Document Type:
Template
Organization/Institution:
The University of Nottingham
Author:
Not specified
Target Audience:
NHS / HSC organizations, Sponsors, CROs
Period of Activity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2024
Institution:
University of Maryland, College Park
Division:
Office of Research Administration, Division of Research
Type of Document:
Handbook / Guidance
Scope:
Sponsored Research Projects
Audience:
Faculty and Staff involved in Sponsored Research
Topics:
Proposal Preparation, Award Administration, Compliance, Ethics, Intellectual Property, Reporting
Revision Date:
November 2024
External References:
OMB Guidance, Federal and Private Funding Regulations
https:
//ora.umd.edu/sponsored-research-toolbox/um-resources/um-policies
Year:
2023
Region / City:
Stony Brook University, New York
Topic:
Institutional Salary Policy for Sponsored Awards
Document Type:
Policy Document
Organization:
Stony Brook University
Author:
Office of Sponsored Programs
Target Audience:
Faculty and staff involved in sponsored research
Period of Effectiveness:
Ongoing
Approval Date:
Not specified
Date of Revisions:
Not specified