№ lp_1_2_64462
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This checklist provides a detailed list of essential documents required by Good Clinical Practice (GCP) before the clinical phase of a trial begins, ensuring regulatory compliance and proper documentation management.
Note:
Year
Topic:
Clinical Trials, Good Clinical Practice (GCP)
Document Type:
Checklist
Target Audience:
Clinical Investigators, Research Coordinators, Regulatory Affairs Professionals
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Note:
Year
Year:
2023
Region / City:
Rwanda
Theme:
Clinical Trials, Good Clinical Practice (GCP) Inspection
Document Type:
Guidelines
Organization / Institution:
Rwanda Food and Drugs Authority (Rwanda FDA)
Author:
Dr. Emile BIENVENU
Target Audience:
Clinical trial regulators, researchers, pharmaceutical professionals
Period of Validity:
Starting from 23/07/2021
Approval Date:
20/05/2021
Date of Revision:
06/01/2023
Note:
Year
Year:
2023
Region / city:
USA
Topic:
Clinical Trials, Regulatory Compliance
Document Type:
Guidelines
Institution:
FDA, UTA
Author:
Unknown
Target Audience:
Researchers, Investigators, Clinical Trial Personnel
Effective Period:
Ongoing
Approval Date:
Unknown
Date of Changes:
Unknown
Note:
Contextual Description
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.
Note:
Year
Topic:
Cloud Infrastructure, DevOps, Cloud Migration
Document Type:
Resume
Author:
Rithvik Katakamsetty
Target Audience:
Potential Employers, Recruitment Agencies, Cloud Infrastructure Specialists
Year:
2025
Region / City:
Birmingham
Theme:
Clinical Research, Good Clinical Practice (GCP)
Document Type:
Policy
Organ / Institution:
University of Birmingham
Author:
University of Birmingham Research Ethics Committee
Target Audience:
Researchers, Clinical Research Staff
Period of Validity:
Ongoing
Approval Date:
Dec-2025
Date of Changes:
Not specified
Date of Review:
2028, Quarter 4 (Oct-Dec)
Year:
2023
Region / City:
Bentonville, AR, Dallas, TX
Theme:
Data Engineering, Cloud Computing, Data Processing, Cloud Architecture
Document Type:
Resume
Organization:
Walmart, Southern California Edison
Author:
Anusha Reddy
Target Audience:
Hiring Managers, Data Engineering Teams
Period of Activity:
Apr 2025-Present, Mar 2024-Feb 2025
Approval Date:
Not specified
Modification Date:
Not specified
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:
2018
Region / City:
San Joaquin Valley, California
Topic:
Healthcare, Agricultural Industry
Document Type:
Report
Organization:
Diringer and Associates, California Rural Legal Assistance Foundation
Author:
Joel Diringer, JD, MPH, Noe Paramo, JD
Target Audience:
Agricultural workers, policymakers, public health professionals
Period of Action:
April 2018
Date of Approval:
April 2018
Date of Changes:
N/A
Contextual Description:
A report examining the impact of Medi-Cal expansion on farmworkers in San Joaquin Valley, addressing both health coverage and economic consequences for agricultural employers.
Institution:
Wayne State University
Program:
Physical Therapy Program
Document type:
Program policy and standards
Subject area:
Physical therapy education
Purpose:
Admission, retention, and graduation requirements
Applicable settings:
Classroom, laboratory, tutorial, and clinical settings
Regulatory and professional references:
American Physical Therapy Association; Commission on Accreditation for Physical Therapy Education
Intended audience:
Physical therapy students and applicants
Professional scope:
Entry-level generalist physical therapy practice
Ethical framework:
Ethical and safe clinical practice standards
Standards categories:
Academic, clinical, physical, and interpersonal abilities
Academic source type:
Institutional academic policy defining professional competency standards
Year:
2026
Region / City:
Brent, London
Type of Document:
Application form
Issuing Authority:
Brent Council
Target Audience:
Charitable organisations and public sector workers providing essential services
Eligibility:
Statutory service workers, NHS employees, home-visiting staff of religious or non-profit organisations
Vehicle Requirements:
Maximum length 6.5m, maximum height 2.5m, maximum weight 5 tonnes
Usage Restrictions:
Only during official duties, not within 750 metres of workplace, not in restricted bays
Application Requirements:
Completed form with applicant and employer declarations
Data Protection:
Personal and vehicle data collected under Data Protection Act for traffic administration and fraud prevention
Year:
2020
Month:
June
Jurisdiction:
United States
Agency:
California Department of Transportation
Division:
Division of Environmental Analysis, Office of Biology
Subject:
Biological assessment
Note:
Subject
Essential fish habitat
Legal framework:
Federal Endangered Species Act
Consultation authorities:
National Marine Fisheries Service
Regulatory references:
50 CFR Ch. IV Sections 402.12 and 402.14(c)
Regulatory updates referenced:
FESA regulations published in 2019
Critical habitat terminology:
Physical or Biological Features
Intended use:
FESA Section 7 consultations
Geographic scope:
State Highway System projects
Document type:
Standardized assessment template
Revision:
Third revision
Accessibility standard:
Americans with Disabilities Act
Source type:
Government technical guidance
Note:
Year
Organization / Institution:
NHS Blood and Transplant
Target Audience:
Healthcare professionals, medical researchers
Contextual Description:
This is a referral form for blood and tissue sample testing, including various genotyping services, used by NHS Blood and Transplant.
Year:
2022
Note:
Region / city
Topic:
Medical Devices, Safety, Compliance
Document Type:
Checklist
Organization / institution:
DFAR Department
Target Audience:
Manufacturers, Regulatory Bodies, Medical Device Industry
Effective Date:
31/10/2022
Review Due Date:
30/10/2025
Year:
2022
Region / city:
Sri Lanka
Topic:
Pharmaceuticals import
Document type:
Invitation for expressions of interest
Organization:
Ministry of Health, Sri Lanka
Author:
Ministry of Health
Target audience:
Pharmaceutical suppliers
Period of validity:
3 months
Approval date:
27th September 2022
Date of amendments:
N/A
Note:
Year
Topic:
Educational Support Strategies
Document Type:
Instructional Support Guidelines
Year:
2026
Region / city:
Sacramento
Subject:
Executive Office Analyst Position Responsibilities
Document Type:
Duties Statement
Agency / Institution:
California Department of Forestry and Fire Protection (CAL FIRE)
Author:
California Department of Forestry and Fire Protection
Target audience:
CAL FIRE employees
Effective period:
From 1/1/2026
Approval Date:
1/1/2026
Date of Changes:
N/A
Note:
Year
Field:
Community Development
Document Type:
Guidelines
Organization / Institution:
Community Development Journal
Target Audience:
Researchers, Practitioners, Academics in Community Development
Contextual Description:
A set of guidelines outlining the expectations and submission process for prospective authors submitting peer-reviewed articles to the Community Development Journal.