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Instructional guidance outlining regulatory, ethical, and practical requirements for drafting and adapting informed consent forms used in pediatric and general clinical trials involving human participants.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
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
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
Note:
Year
Subject:
Clinical Trials, Medical Research
Document Type:
Template
Organization / Institution:
EU Clinical Trials Expert Group
Target Audience:
Sponsors of clinical trials
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
Year:
Not applicable
Region / City:
Not applicable
Subject:
Research ethics and manuscript submission
Document Type:
Submission Template
Organization / Institution:
Not applicable
Author:
Not applicable
Target Audience:
Researchers, Authors submitting manuscripts
Period of validity:
Not applicable
Approval Date:
Not applicable
Date of Changes:
Not applicable
Note:
Year
Region / City:
Buffalo, NY
Topic:
Research Study Consent
Document Type:
Informed Consent Form
Institution:
University at Buffalo
Author:
University at Buffalo Research Compliance
Target Audience:
Research Participants
Year:
2016
Region / City:
United States
Topic:
Electronic Informed Consent (eIC)
Document Type:
Guidance
Agency / Institution:
Office for Human Research Protection (OHRP), Food and Drug Administration (FDA)
Author:
Office for Human Research Protection (OHRP), FDA
Target Audience:
Researchers, IRBs, Clinical Investigators, and Study Participants
Period of Validity:
Ongoing
Approval Date:
December 2016
Date of Revisions:
Not specified
Year:
2018
Region / City:
United States
Theme:
Cancer prevention, clinical trials
Document Type:
Template
Organ / Institution:
National Cancer Institute (NCI), National Institutes of Health (NIH)
Author:
NCI
Target Audience:
Researchers, clinical trial participants
Period of Validity:
Ongoing
Approval Date:
January 19, 2018
Date of Changes:
N/A
Note:
Year
Topic:
Human Subject Research
Document Type:
Informed Consent Form
Organization / institution:
Coastal Carolina University
Author:
[PI Name]
Target Audience:
Potential research participants