№ lp_1_2_30072
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This document outlines the process for transferring a clinical site, including patient safety measures, operational continuity, and data integrity during relocation.
Year:
2018
Region / City:
Lakeland
Theme:
Clinical Trials, Office Relocation, Research Protocols
Document Type:
Standard Operating Procedure
Organization / Institution:
Lakeland Clinical Trials
Author:
Philippa Williams
Target Audience:
Clinical Research Team, Administrative Team
Period of Validity:
From 22 Nov 2018
Approval Date:
10 Sep 2018
Date of Last Revision:
NA
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Year:
2025
Region / City:
Lakeland
Topic:
IRB Protocol Submission and Review Process
Document Type:
User Guide
Organization / Institution:
Lakeland Regional Health
Author:
Lakeland Regional Health IRB
Target Audience:
Researchers, IRB Members
Effective Date:
June 10, 2025
Date of Approval:
Not specified
Date of Changes:
Not specified
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
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
Note:
Year
Topic:
Environmental Management, Risk Assessment
Document Type:
Procedure
Organization / Institution:
North West Biomass Limited
Target Audience:
Site Staff, Contractors
Note:
Year
Topic:
Clinical Research, Retinal Diseases
Document Type:
Clinical Research Site Information
Organization / Institution:
Jaeb Center for Health Research (JCHR)
Target Audience:
Clinical researchers, Investigators, Healthcare professionals
Year:
2010
Region / City:
Europe
Theme:
Grid Computing, Infrastructure, e-Science
Document Type:
Policy
Organization / Institution:
EGI-InSPIRE
Author:
David Kelsey
Target Audience:
Researchers, Site Administrators, Grid Operators
Approval Date:
13/07/2010
Approval Body:
EGI-InSPIRE
Modification Date:
N/A
Date of Document:
13/07/2010
Version:
1.0
Policy Group:
Security Policy Group
Contact Person:
David Kelsey, STFC, UK
Note:
Year
Region / City:
Burlington
Document Type:
Application Form
Topic:
Site Plan Review and Development
Governing Ordinance:
Burlington Unified Development Ordinance
Pre-application Conference Required:
Yes
Special Districts Mentioned:
LHO District, FHO Districts
Infrastructure Requirements:
Public and private utilities
Amendments and Variances:
Applicable if modifying previous approvals
Submission Materials:
Paper and digital copies required
Phased Development:
Possible
Sustainability Incentives:
Optional
Owners’ Association:
Possible