№ lp_1_26936
File format: docx
Character count: 3645
File size: 49 KB
Administrative application form used in the regulatory approval process for amendments to approved clinical trial investigators and sites in South Africa.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2021
Region / City:
Charleston County, South Carolina
Topic:
Building Permit Application, Zoning, Construction Plans
Document Type:
Checklist
Author:
Charleston County Government
Target Audience:
Contractors, Homeowners, Design Professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2022
Region / city:
Pennsylvania
Topic:
Stream Habitat Restoration
Document type:
Report
Organization / institution:
Pennsylvania Fish and Boat Commission (PFBC)
Author:
Pennsylvania Fish and Boat Commission
Target audience:
Environmental Managers, Conservationists, Fisheries Professionals
Period of validity:
N/A
Approval date:
N/A
Modification date:
N/A
Year:
2021
Region / city:
California
Theme:
Education, Regulations
Document type:
Final Statement of Reasons
Institution:
California Commission on Teacher Credentialing
Target audience:
Educators, School administrators, Policy makers
Period of validity:
Ongoing
Approval date:
April 2021
Amendment dates:
February 2021, July 2021, December 2021
Note:
Context
Year:
2026
Region / City:
Greenwich
Topic:
Student Governance, University Constitution
Document Type:
Official Amendments
Organization / Institution:
Greenwich Students’ Union
Author:
Henry Setter, GSU President
Target Audience:
Students, Trustees, University Staff
Period of Effect:
From approval onward
Approval Date:
2026
Date of Amendments:
2026
Bid Number:
ECR/SCM/PRCL2/EL/10/2021
Closing Date:
21 January 2022
Closing Time:
12:00 NOON
Delivery Address:
Passenger Rail Agency of South Africa, PRASA CRES, 8 Station Street Station Building, East London
Location:
East London, South Africa
Scope:
Refurbishment, alterations, and additions at Mtsotso, Mdantsane, Mount Ruth, and Egerton Station
Duration:
12 months construction period
Type:
Request for Proposal (RFP)
Issuing Organization:
Passenger Rail Agency of South Africa (PRASA)
Confidentiality Requirements:
Applicable to all bidders and associated parties
Regulatory Notice:
Recipients outside South Africa should observe relevant local regulations
Year:
2018
Region / City:
Australia
Theme:
Building regulations, construction design
Document Type:
Performance-based design brief
Organ / Institution:
National Construction Code
Author:
Not specified
Target Audience:
Building professionals, surveyors, architects
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
2019
Year:
2022
Region / City:
Not specified
Topic:
Wastewater Management, Environmental Regulations
Document Type:
Rule
Organization / Institution:
EQD
Author:
Not specified
Target Audience:
Environmental Agencies, Wastewater Management Operators
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Jurisdiction:
Canada
Authority:
Health Canada
Directorate:
Medical Devices Directorate
Document type:
Regulatory guidance and administrative instructions
Regulatory framework:
Medical Devices Regulations
Regulations issued:
July 1998
Subject matter:
Amendments for non-significant additions or deletions of catalogue or model numbers
Application scope:
Sections 28 to 31 and Section 34 of the Medical Devices Regulations
Exclusions:
Private Label licences
Submission requirements:
Fax-back form with copy of page 1 of the applicable licence
Processing timeframe:
7 calendar days from receipt
Authorization effect:
Amended licence authorizes sale of listed devices and catalogue numbers
Related guidance:
Guidance for the Interpretation of Significant Change; Guidance for the Interpretation of Sections 28 to 31
Administrative source:
Medical Devices Directorate, Health Canada
Year:
2020
Region / City:
Augsburg, Germany
Topic:
Engineering thermoplastics, e-mobility, electronics
Document type:
Press release
Organization:
Ultrapolymers Deutschland GmbH
Author:
Konsens PR GmbH & Co. KG
Target audience:
Electronics and engineering industry professionals
Period of validity:
October 2020 and beyond
Date of approval:
October 2020
Date of changes:
Not specified
Year:
2020
Region / City:
Chicago
Topic:
Affordable Housing Compliance
Document Type:
Project Data Sheet
Agency / Organization:
City of Chicago
Author:
City of Chicago Department of Buildings
Target Audience:
Architects, Engineers, Contractors
Period of Validity:
Ongoing
Approval Date:
February 14, 2020
Date of Revisions:
February 14, 2020
Year:
2017
Region / City:
Maryland
Topic:
Shell Record Layout, Workday Benefits
Document Type:
Technical Specifications
Institution:
Maryland Department of Budget and Management (DBM)
Author:
SPS (LL)
Target Audience:
Universities, MDOT, Judiciary, General Assembly of MD
Effective Period:
March 2017
Approval Date:
March 10, 2017
Amendment Date:
March 10, 2017
Year:
1998
Region / city:
N/A
Subject:
Catalytic Asymmetric Hydrogenation and Enantioselective Reactions
Document type:
Scientific Paper
Organization / institution:
N/A
Author:
N/A
Target audience:
Chemists, Researchers
Period of validity:
N/A
Approval date:
N/A
Date of changes:
N/A
Keywords:
Enantioselectivity, Catalysis, Ketones, Reduction, Hydrogenation, Additions
Contextual description:
This is a scientific paper on catalytic enantioselective reactions, including ketone reduction and hydrogenation mechanisms.
Year:
2017
Date:
May 7, 2017
Subject:
Biblical authority in the New Testament church
Theme:
Expediencies and additions in religious practice
Type of document:
Sermon outline
Religious tradition:
Christianity
Biblical focus:
New Testament teachings
Primary sources cited:
John 11:50; John 16:7; Hebrews 12:10; 1 Corinthians 6:12; 1 Corinthians 10:23; 2 Samuel 6:6–7; Exodus 25:12–14; Numbers 4:15; 1 Chronicles 15:11–15; Revelation 22:18–19; Deuteronomy 12:32; Matthew 15:3–9; Hebrews 10:25; Acts 5:12; Acts 19:9–10; Acts 20:7–8; 1 Corinthians 16:19; 1 Corinthians 11:22, 34; 1 Corinthians 4:6; Colossians 3:17; 1 Corinthians 9:19–23
Key topics:
Specific and generic authority; worship practices; singing; instrumental music; assembling; church work; baptism
Intended audience:
Members of the New Testament church
Language:
English
Year:
2026
Region / City:
South Australia
Topic:
Budgerigar Breeding
Document Type:
Guide
Organization / Institution:
Goodwood
Author:
Bill Stone
Target Audience:
Budgerigar fanciers and breeders
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Context:
A guide on selecting high-quality stock for breeding exhibition budgerigars, focusing on the importance of pure strain breeding and the effects of inbreeding versus cross-strain breeding.
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