№ lp_1_06714
File format: docx
Character count: 4310
File size: 47 KB
A regulatory source document defining required information for notifying Australian authorities of planned or amended clinical trials under the CTN scheme.
Jurisdiction:
Australia
Regulatory framework:
Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme
Document type:
Regulatory notification form
Scope:
Clinical trials involving medicines, biologicals, medical and therapeutic devices
Trial phases covered:
Phase I–IV, bioavailability/bioequivalence, device studies
Subjects:
Human participants
Ethics oversight:
Human Research Ethics Committee (HREC)
Approving authority:
Relevant institutional authority
Geographic coverage:
Australian trial sites with optional international sites
Responsible party:
Lead Investigator
Fee responsibility:
Lead Investigator
Related institution:
La Trobe University
Submission requirement:
Completed form and ethics approval
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
1989
Region / City:
Australia
Theme:
Clinical trials, therapeutic goods, medical research
Document Type:
Operational procedures
Organization / Institution:
SESLHD
Author:
SESLHD
Target Audience:
Coordinating Principal Investigators, Sponsors, Clinical Trial Coordinators
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2015
Region / City:
Australia
Topic:
Clinical Trials, Therapeutic Goods
Document Type:
Guidelines
Organization:
Therapeutic Goods Administration (TGA)
Author:
Dr Helen Atkinson
Target Audience:
Researchers, Clinical Trial Investigators
Validity Period:
Since July 1, 2015
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Contextual Description
Year:
2024
Region / City:
Pretoria
Subject:
Court Schedules
Document Type:
Court Listing
Institution:
Gauteng Division, Pretoria
Target Audience:
Legal professionals, Court staff
Period of Validity:
20 February 2024
Approval Date:
20 February 2024
Date of Changes:
N/A
Note:
Year
Subject:
Clinical Trials, Medical Research
Document Type:
Template
Organization / Institution:
EU Clinical Trials Expert Group
Target Audience:
Sponsors of clinical trials
Document type:
Instructional guidance
Subject:
Informed consent forms in clinical research
Context:
Clinical trials involving human participants
Regulatory and ethical framework:
Research ethics and regulatory compliance
Organizations referenced:
Children’s Oncology Group; National Cancer Institute; National Institutes of Health; OCREB
Funding context:
Public funding by the National Cancer Institute
Intended audience:
Consent form authors; clinical trial investigators; participating centres
Geographic scope:
North America
Population referenced:
Children and adolescents with cancer; parents or legal guardians
Related materials:
Provincial informed consent form templates; lay terminology glossary
Year:
2025
Region / city:
Ireland
Topic:
Clinical trials, Primary care, Research funding
Document type:
Request Form
Organization / institution:
Health Research Board
Author:
HRB Primary Care Clinical Trials Network
Target audience:
Lead Investigators in clinical trials
Effective period:
Until November 2026
Approval date:
N/A
Date of amendments:
N/A
Year:
2024
Region / City:
N/A
Topic:
Critical Appraisal
Document Type:
Checklist
Organization / Institution:
Critical Appraisal Skills Programme (CASP)
Author:
Critical Appraisal Skills Programme (CASP)
Target Audience:
Healthcare professionals, researchers
Date of Approval:
N/A
Date of Modification:
N/A
Note:
Year
Document type:
Template
Institution / organization:
EU Clinical Trials Expert Group
Target audience:
Sponsors of clinical trials
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
Year:
2018
Region / City:
Melbourne
Subject:
Clinical Trials, Monitoring, Investigator-Initiated Trials
Document Type:
Template
Organization / Institution:
Melbourne Children’s Trials Centre, Clinical Research Development Office (CRDO)
Author:
Not specified
Target Audience:
Sponsor-Investigators, Clinical Research Professionals
Effective Period:
Not specified
Approval Date:
01 May 2018
Date of Changes:
Not specified
Note:
Year
Subject:
Clinical Trials, FDA, NIH, IND, IDE
Document Type:
Template
Organization / Institution:
National Institutes of Health (NIH)
Target Audience:
Clinical Researchers, Investigators
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
Organization:
Joanna Briggs Institute (JBI)
Document type:
Critical appraisal tool / checklist
Topic:
Randomized controlled trials (RCTs)
Target audience:
Researchers conducting systematic reviews
Year:
2020
Source:
JBI Manual for Evidence Synthesis
Format:
Checklist for individual participants in parallel group RCTs
Purpose:
Assess methodological quality and risk of bias in RCTs
Reference:
Tufanaru C, Munn Z, Aromataris E, Campbell J, Hopp L. Chapter 3: Systematic reviews of effectiveness
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.
Year:
Not specified
Country:
United States
Institution:
National Center for Complementary and Integrative Health
Parent organization:
National Institutes of Health
Document type:
Charter
Subject area:
Clinical trial oversight
Governing body:
Data and Safety Monitoring Board
Scope:
Data and safety monitoring of clinical trials
Regulatory references:
NOT-98-084; NOT-99-107
Funding source:
National Center for Complementary and Integrative Health
Intended users:
Clinical trial investigators and monitoring board members
Year:
2015
Region / City:
CRC
Topic:
Clinical Trials, Corrective and Preventive Action
Document Type:
Standard Operating Procedure
Organization:
Clinical Research Center (CRC)
Author:
Not specified
Target Audience:
Clinical Research Personnel
Period of Validity:
Ongoing
Approval Date:
01/01/2015
Effective Date:
01/01/2015
Review/Revision Date:
06/01/2016
Year:
2015
Region / City:
Not specified
Subject:
Clinical Research Procedures
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
Clinical Research Center (CRC)
Author:
Not specified
Target Audience:
Site staff involved in clinical trials
Period of validity:
Not specified
Approval Date:
01/01/2015
Effective Date:
06/01/2016
Revision History:
Ongoing, with revision dates
Source Documents:
Clinical trial records, CRFs, IRB approvals, training certificates
Sponsor:
Not specified
Keywords:
Site Initiation Visit, SOP, clinical trial, CRC
Date:
August 3, 2011
Author:
Lisa Hull
Document type:
Personal letter
Subject:
Support for Anna Stubblefield
Institutions mentioned:
Rutgers University; Essex County Superior Court
Individuals mentioned:
Anna Stubblefield; DMan; Judge Siobhan Teare
Location:
Newark, New Jersey
Related event:
Criminal trial beginning September 9, 2011
Purpose:
Request for awareness, attendance, and support
Funding information:
Defense fund contribution details
Communication medium:
Written correspondence
Note:
Year
Topic:
Clinical Trials
Document Type:
Plan
Target Audience:
Study team, sponsors, and regulatory authorities
Year:
2014
Region / City:
Geneva
Topic:
Revision of TGP/8, DUS Trial Design and Data Analysis
Document Type:
Draft Document
Organization / Institution:
International Union for the Protection of New Varieties of Plants (UPOV)
Author:
UPOV Office
Target Audience:
Technical Committees, Working Parties for Vegetables, Agricultural Crops, Fruit Crops, Ornamental Plants, and others involved in plant variety protection
Period of Validity:
Ongoing (as of 2014)
Approval Date:
May 27, 2014
Date of Changes:
N/A