№ lp_1_2_26304
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This document is a checklist for investigators conducting clinical trials, ensuring adherence to Good Clinical Practice (GCP) standards and compliance with regulatory requirements.
Year:
2016
Region / city:
Not specified
Subject:
Clinical trial regulations, GCP compliance
Document type:
Checklist
Institution:
Not specified
Author:
Not specified
Target audience:
Investigators, trial staff
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
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Document type:
Regulatory guidance
Subject:
Pharmacovigilance reporting
Regulatory framework:
ICH E2F
Scope:
Clinical trials of investigational medicinal products
Reporting obligation:
Annual safety reporting
Intended recipients:
Regulatory authorities, ethics committees, sponsors
Key entities referenced:
Medicines and Healthcare Products Regulatory Agency (MHRA)
Covered document sections:
Executive summary, safety actions, cumulative exposure, adverse event reporting
Confidentiality status:
Contains confidential and unblinded safety data
Applies to:
Non-commercial sponsors
Document type:
Regulatory guidance
Subject area:
Nonclinical pharmacology summaries
CTD module:
Module 2.6.3
Standard referenced:
ICH M4S — The CTD Safety
Submission format:
eCTD
Regulatory framework:
Common Technical Document
Issuing organizations referenced:
International Council for Harmonisation, U.S. Food and Drug Administration
Referenced guidance dates:
August 2001
Content elements:
Primary pharmacodynamics, secondary pharmacodynamics, safety pharmacology, pharmacodynamic drug interactions
Technical requirements:
INN usage, GLP compliance identification, study numbering, CTD location referencing
Source type:
Guidance with annotated sample tables
Note:
Year
Subject:
Intangible Cultural Heritage (ICH)
Document Type:
Questionnaire
Target Audience:
Communities involved in ICH practices, researchers, organizations
Contextual description:
A model questionnaire for identifying elements of intangible cultural heritage when creating inventories.
Note:
Year
Contextual Description:
International ethical and scientific standards for conducting clinical trials with human subjects, outlining compliance with ICH-GCP Guidelines and additional requirements for NYU’s HRPP.
Year:
2024
Region / City:
Paris
Theme:
Disaster Risk Reduction, Intangible Cultural Heritage
Document Type:
Lesson Plan
Organization:
UNESCO
Author:
UNESCO
Target Audience:
Stakeholders involved in the inventorying, safeguarding, and mobilization of intangible cultural heritage in disaster contexts
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2026
Region:
European Union / Non-EU agencies
Subject:
Pharmaceutical quality assessment
Document type:
Regulatory submission form
Organization:
European Medicines Agency
Author:
Not specified
Target audience:
Regulatory affairs professionals
Period covered:
Not specified
Date issued:
2026
Reference standard:
ICH Common Technical Document
Subject Area:
Clinical research regulation
Document Type:
Regulatory document review worksheet
Related Standards:
ICH GCP Guidelines; 45 CFR 46; 21 CFR 50; 21 CFR 312
Institution / Authority Referenced:
Division of Microbiology and Infectious Diseases (DMID)
Regulatory Authority Referenced:
U.S. Food and Drug Administration (FDA)
Ethics Oversight Reference:
Office for Human Research Protections (OHRP)
Purpose:
Guidance for completion, review, and maintenance of essential regulatory documents for clinical trials
Document Structure:
Tier-based classification of regulatory documents with section and page references
Document Tiers:
Tier 1A; Tier 1B; Tier 2; Closeout Documents
Key Forms Referenced:
Form FDA 1572; Investigator of Record Form; Financial Disclosure Form
Key Roles Referenced:
Principal Investigator; Sub-Investigator; Clinical Site Monitor
Oversight Bodies Referenced:
Institutional Review Board (IRB); OHRP
Applicable Study Types:
DMID-supported IND and IDE clinical studies
Primary Users:
Site staff conducting DMID supported studies; clinical site monitors; DMID contractors
Core Documentation Covered:
Investigator credentials, IRB approvals, informed consent documentation, laboratory certifications, regulatory compliance records
Compliance Focus:
Verification of adherence to Good Clinical Practice and applicable federal regulations
Year:
2012–2021
Region / City:
Washington State, USA
Document Type:
Membership roster
Organization:
SACH (State Advisory Council on Homelessness), ICH (Interagency Council on Homelessness)
Positions Included:
Local Government Representatives, Non-Profit Representatives, Housing Authority Representative, Philanthropic Representative, Federal Government Representative, Homeless Person Representatives, Business Representative, ICH Agency Representatives, Youth Representative
Appointments:
Various dates 2012–2017
Expirations:
Various dates 2018–2021
Contact Information:
Included for each member and agency representative
Affiliated Agencies:
Kitsap County Department of Human Services, Washington State Coalition Against Domestic Violence, Okanogan County Community Action Council, Lower Columbia Community Action Program, Kennewick Housing Authority, Campion Foundation, U.S. Department of Housing and Urban Development, Department of Commerce, DSHS divisions, Employment Security Department, Department of Veterans Affairs, Health Care Authority, Office of Superintendent of Public Instruction, State Board of Community and Technical Colleges, Department of Corrections, Governor’s Executive Policy Office
Purpose:
Lists appointed members and agency representatives with roles, contact details, and term information
Year:
2026
Region / City:
International
Topic:
Quality Risk Management in Pharmaceuticals
Document Type:
Workshop Overview
Organization / Institution:
ICH
Author:
Not specified
Intended Audience:
Pharmaceutical professionals and quality managers
Related Guidelines:
ICH Q9, ICH Q10
Content Focus:
Risk assessment, risk control, risk communication, risk review, managing subjectivity and bias, use of data and knowledge
Document type:
Application form
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Country:
South Africa
Subject:
Additions and/or changes in investigators and clinical trial sites
Document number:
GLF-CEM-CT-01D
Related form:
CTF3
Version:
v4
Date of first approval:
October 2019
Date of latest update:
September 2022
Update history:
October 2019 first version approved; March 2020 administrative changes; September 2022 administrative changes, checklist update, appendix removal, document number change
Applicable actions:
Additional investigator(s); Change of investigator(s); Additional site(s); Change in site location
Required attachments:
Cover letter; Investigator documents; Site staff documents; Proof of payment
Approval bodies referenced:
Ethics Committee(s)
Intended applicant:
Sponsor, CRO, or local sponsor company
Regulated area:
Clinical trials
Note:
Year
Topic:
Financial Disclosure
Document Type:
Form
Organization / Institution:
Study Sponsor
Target Audience:
Clinical Investigators, Sub-Investigators
Year:
2024
Region / City:
USA
Topic:
Clinical Research, Regulatory Compliance
Document Type:
Guidance Document
Author:
OVPRI Regulatory Affairs
Target Audience:
Principal Investigators, Research Administrators, Clinical Research Coordinators
Period of Effectiveness:
N/A
Approval Date:
04/25/2024
Amendment Date:
07/09/2024
Description:
Guidance document detailing the steps and regulatory requirements for transferring clinical studies between principal investigators, including documentation updates and approvals required for drug, device, and investigator-initiated studies.
Issuing organization:
National Institutes of Health
Program:
Maximizing Investigators’ Research Award for Early Stage Investigators
Funding mechanism:
R35
Clinical trial policy:
Clinical Trial Optional
Document type:
Application guidance and checklist
Subject area:
Biomedical and behavioral research funding
Target applicants:
Early Stage Investigators
Related documents:
Funding Opportunity Announcement; SF424 (R&R) Research Instructions
Application components:
Forms, narrative attachments, budgets, human subjects and clinical trials information
Formatting requirements:
Font, margins, layout, and hyperlink rules specified
Jurisdiction:
United States
Year:
2023
Region / City:
USA
Subject:
Clinical Research, Financial Disclosure
Document Type:
Form
Organization / Institution:
FDA
Author:
FDA
Target Audience:
Clinical investigators
Effective Period:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / city:
N/A
Topic:
Clinical Trial Consent
Document Type:
Research Protocol
Organization / Institution:
DF/HCC
Author:
N/A
Target Audience:
Parents or Guardians of Children Participating in Clinical Trials
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
November 2023
Region / City:
London
Topic:
Research Funding
Document Type:
Policy
Organization:
British Heart Foundation
Author:
British Heart Foundation
Target Audience:
Principal Investigators, Co-applicants, Research Staff
Period of Application:
Until 3 months after the grant end date
Approval Date:
November 2023
Date of Changes:
N/A
Year:
2022
Region / City:
London
Topic:
Clinical Trials, Investigational Medicinal Products, Clinical Development
Document Type:
Template
Organization / Institution:
University College London
Author:
University College London
Target Audience:
Clinical researchers, Investigators, Medical professionals involved in Clinical Trials
Effective Date:
02-Mar-2022
Version:
2.0
Period of Validity:
Reviewed annually
Approval Date:
02-Mar-2022
Date of Last Revision:
Not specified
Year:
20XX
Region / City:
Durham, NC
Theme:
Clinical Trials, Investigational Drugs
Organization / Institution:
Duke University
Author:
Not specified
Target Audience:
Investigators, Institutional Review Boards, Ethics Committees
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified