№ lp_1_2_31780
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A toolkit for researchers detailing the required "Essential Documents" and recordkeeping practices for FDA-regulated clinical trials.
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
Price: 8 / 10 USD
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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
Note:
Year
Topic:
Clinical Trials, Good Clinical Practice (GCP)
Document Type:
Checklist
Target Audience:
Clinical Investigators, Research Coordinators, Regulatory Affairs Professionals
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
Note:
Year
Year:
2026
Region / City:
N/A
Subject:
Research Documentation, Regulatory Compliance
Document Type:
Checklist
Institution / Organization:
Smartsheet
Author:
Smartsheet
Target Audience:
Research Professionals, Investigators
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2020
Region / City:
Not specified
Theme:
Faculty evaluation, tenure, promotion
Document type:
Administrative guidelines
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Faculty members undergoing review
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Year:
N/A
Region / City:
N/A
Topic:
Clinical Research Documentation
Document Type:
Template
Institution / Organization:
N/A
Author:
N/A
Target Audience:
Research Coordinators, Investigators, Clinical Trial Sites
Effective Period:
N/A
Approval Date:
N/A
Revision Date:
N/A
Year:
2012
Note:
Region / City
Topic:
Clinical Research, Regulatory Compliance
Document Type:
Checklist
Target Audience:
Study coordinators, investigators, and individuals responsible for regulatory binder management
Approval Date:
11 May 2012
Amendment Date:
24 April 2013 (Version 2.0), 12 May 2014 (Version 3.0)
Year:
2023
Region / City:
Not specified
Topic:
Clinical research documentation
Document Type:
Guidelines
Organization:
Not specified
Author:
Not specified
Target Audience:
Study coordinators, investigators, and clinical researchers
Effective Period:
Not specified
Approval Date:
Not specified
Revision Date:
Not specified
Note:
Context
Note:
Year
Subject:
Engineering
Document Type:
Instructional Guide
Organization / Institution:
PLTW
Target Audience:
Students, Teachers
Year:
2020
Region / City:
Australia
Theme:
Asphalt Mix Design
Document Type:
Technical Specification
Organization:
Department of Transport
Author:
Department of Transport
Target Audience:
Engineers, Contractors
Period of Effectiveness:
March 2020 onwards
Approval Date:
March 2020
Date of Changes:
N/A
Year:
2026
Note:
Region / City
Topic:
Asphalt Binder Testing
Document Type:
Data Sheet
Organization:
AASHTO re:source
Target Audience:
Laboratories performing asphalt binder testing
Approval Date:
January 15th, 2026
Description:
Proficiency sample data sheet for performance graded asphalt binder testing, outlining required tests and methods.
Subject:
English Language Arts
Document Type:
Course syllabus and binder table of contents
Educational Level:
Secondary education
Literary Work Studied:
The Great Gatsby
Author Referenced:
F. Scott Fitzgerald
Sections Included:
Reading Section; Writing Section; Research Section; Real World Section
Curriculum Components:
Reading standards; Writing standards; Research and citation practices; Career communication materials
Citation Styles Mentioned:
MLA; APA
Assessment Elements:
FSA rubric writing examples; thesis statement practice; persuasive strategy exercises; claim and evidence materials
Instructional Materials:
Cornell notes assignments; graphic organizers; guiding questions; annotated bibliography example
Additional Topics:
Proper emailing; résumé writing basics; cover letter preparation
Academic Integrity Topic:
Staying Academically Honest
Year:
2023-2024
Field:
Vascular Biology and Thrombosis Research
Type of document:
Award Announcement / Application Form
Sponsor:
Bernd R. Binder
Target audience:
First authors of original research articles
Submission deadline:
June 30, 2025
Award date:
October 22, 2025
Location of award ceremony:
Prague, Czech Republic
Award amount:
€2,500 per prize
Included benefits:
Free registration at ECTH Congress, travel cost reimbursement
Publication requirement:
Peer-reviewed international journal article
Application requirements:
Signed application form, PDF of paper, brief CV, description of significance, co-author consent