№ lp_2_3_38404
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This document is a checklist for Principal Investigators to ensure compliance with ICH-GCP principles during clinical trials involving human subjects.
Note:
Year
Subject:
Clinical Trials (Human Subject Research)
Document Type:
Checklist
Target Audience:
Principal Investigators, Quality Assurance/Quality Improvement staff
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Note:
Year
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:
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
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
Note:
Year
Topic:
Financial disclosure, clinical study
Document Type:
Form
Target Audience:
Investigators, Sub-Investigators, Clinical Research Participants
Note:
Year
Year:
2026
Region / City:
Mysuru, Karnataka
Topic:
Public Health, Employment Opportunity
Document Type:
Job Posting
Organization / Institution:
KHPT
Author:
KHPT
Target Audience:
Job Seekers
Period of Action:
2 months
Approval Date:
2026-02-05
Date of Changes:
N/A
Note:
Year
Note:
Year
Subject:
Surety Bond Rider
Document Type:
Bond Rider
Organization / Institution:
American Alternative Insurance Corporation
Note:
Grade
Region / City:
Ipswich, Suffolk
Theme:
Educational Psychology, Inclusion Services
Document Type:
Job Description
Organization:
Suffolk County Council
Target Audience:
Professionals in psychology and education
Period of Validity:
Temporary (Maternity Cover)
Year:
2026
Region / City:
Suffolk, Ipswich
Topic:
Transport Planning
Document Type:
Job Description
Organization:
Suffolk County Council
Author:
Not specified
Target Audience:
Professionals in transport planning, potential applicants
Period of Validity:
Permanent
Approval Date:
Not specified
Amendment Date:
Not specified