№ lp_2_3_25661
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File size: 54 KB
Legal agreement establishing the terms and conditions governing the conduct, regulatory compliance, confidentiality, intellectual property, and operational responsibilities for an investigator initiated clinical study in Australia.
Type of Document:
Clinical Trial Research Agreement
Jurisdiction:
Australia
Parties:
Institution and Organisation
Subject:
Investigator Initiated Study
Related Legislation:
Privacy Act 1988 (Cth); A New Tax System (Goods and Services Tax) Act 1999 (Cth)
Regulatory Authorities:
Therapeutic Goods Administration (TGA); National Health and Medical Research Council (NHMRC)
Applicable Guidelines:
ICH Good Clinical Practice (CPMP/ICH/135/95) as adopted by TGA
Scope:
Conduct of a clinical study in accordance with an approved Protocol
Key Roles:
Principal Investigator; Responsible Human Research Ethics Committee (HREC)
Confidentiality:
Protection of Confidential Information excluding Personal Information
Intellectual Property:
Allocation and definition of Background and Study-related Intellectual Property
Study Components:
Protocol; Investigator’s Brochure; Case Report Forms; Biological Samples; Investigational Product
Completion Criteria:
Database lock and provision of Essential Documents including HREC acknowledgment
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Organisation:
Canberra Health Services
Document type:
Guideline
Reference number:
CHS25/225
Jurisdiction:
Australian Capital Territory
Healthcare setting:
Public health services
Subject area:
Medication management
Professional scope:
Nursing and midwifery practice
Approved by:
Drug and Therapeutics Committee
Target professionals:
Registered nurses and registered midwives
Patient groups:
Adults, children 12 years or older, and selected medicines for children under 12 years
Exclusions:
Neonates, Special Care Nursery patients, Neonatal Intensive Care Unit patients
Regulatory framework:
Australian medicines scheduling (Schedules 2, 3, 4, and 8)
Content components:
Governance, safe use, documentation, approved medicine lists
Year:
2025
Region / city:
Netherlands
Topic:
Clinical Trials, Industry, Medicine
Document Type:
Agreement
Institution:
Nationale Federatie van Universitair Medische Centra (NFU), vereniging Samenwerkende Topklinische opleidingsZiekenhuizen (STZ), Vereniging Innovatieve Geneesmiddelen, Stichting Het Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL), Prinses Máxima Centrum voor Kinderoncologie, Associatie van Contract Research Organisaties in Nederland (ACRON)
Author:
Not specified
Target audience:
Sponsors, CROs, Research Institutions
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Context:
A template for clinical trial agreements between industry sponsors, academic and non-academic hospitals in the Netherlands, including protocols, financial arrangements, and data protection requirements.
Year:
2023-2025
Region / City:
N/A
Subject:
Tenure Review Process
Document Type:
Procedural Guide
Institution:
N/A
Author:
Michael Susi, Jessie Tong, Margaret Edsall, Angel Flesher, Eugenia Lean, Mary Boyce
Target Audience:
Faculty members undergoing tenure review
Period of Validity:
2023-2025
Approval Date:
N/A
Date of Modifications:
N/A
Year:
2021
Region / City:
Not specified
Topic:
Patient follow-up process
Document Type:
Standard Operating Procedure (SOP)
Issuing Organization:
Not specified
Author:
Kirstin Eadie
Target Audience:
Clinical and administrative staff, operational managers, BI team
Effective Period:
Not specified
Approval Date:
27th September 2021
Date of Changes:
Not specified
State:
New Jersey
Country:
United States
Issuing body:
New Jersey Department of Education, Division of Teaching and Learning Services
Legal reference:
N.J.A.C. 6A:8-2.1
Standards last adopted:
2020
Review process initiated:
May 2025
Subject area:
Career readiness, financial literacy, information literacy, key competencies
Education levels:
Kindergarten through Grade 12
Domains:
Career Readiness; Personal Financial Literacy; Information Literacy; Key Competencies and Skills
Document structure:
Framework, disciplinary concepts, developmental progressions, performance expectations by grade band, summary of changes
Type of document:
State educational standards framework
Year:
2020
Region / city:
N/A
Topic:
Network procedure correction
Document type:
Change Request
Organization:
3GPP
Author:
Mediatek Inc.
Target audience:
Technical experts and network engineers
Effective period:
N/A
Approval date:
2020-06-08
Modification date:
N/A
Release:
Rel-16
Work item code:
TEI16
Category:
F
Clauses affected:
5.5.2.3.5
Summary:
The change request proposes a correction to the handling of abnormal cases in network initiated detach procedures, specifically addressing synchronization issues between the network and UE.
Year:
2025
Region / city:
Zurich
Theme:
Oncology, Clinical Trials
Document Type:
Funding Proposal
Institution:
University of Zurich, CCCZ
Author:
N/A
Target Audience:
Researchers, Investigators, Clinical Trials Applicants
Validity Period:
2025
Approval Date:
N/A
Date of Changes:
N/A
Context:
Detailed proposal outline for a research funding call for investigator-initiated clinical trials in oncology, including project description, team structure, cost estimate, and timelines.
Year:
2021
Region / City:
Canberra
Subject:
Surgery, Postponement, Elective Surgery
Document Type:
Standard Operating Procedure
Organization:
Canberra Health Services
Author:
Policy Team
Target Audience:
Medical Officers, Registered Nurses, Management/Executive Officers
Period of Validity:
Not specified
Approval Date:
12 November 2021
Amendment Date:
Not specified
Related Policies:
Elective Surgery Access, Clinical Records Management, Informed Consent, Occupational Violence, Consumer Feedback Management
Evaluation:
Monthly reviews of all elective surgery postponements
Legislation:
Health Records (Privacy and Access) Act 1997, Human Rights Act 2019, Work Health and Safety Act 2011
References:
Elective Surgery Access and Management Policy (2021), Waiting Time and Elective Surgery Policy (2012), Elective Surgery Access Policy (2015)
Search Terms:
Postponement, Surgery, Elective, Rescheduling, Elective Waiting List
Contextual Description:
This is a procedural document outlining the steps and guidelines for hospital-initiated postponement and rescheduling of elective surgeries at Canberra Health Services.
Year:
2023
Region:
Western Australia
Type of document:
Structured Administration and Supply Arrangement (SASA)
Authority:
Chief Executive Officer of Health under Part 6 of the Medicines and Poisons Regulations 2016
Issuer:
Dr Andrew Robertson, Chief Health Officer, Department of Health WA
Practitioner:
Registered Pharmacists with approved training
Practice setting:
Registered community pharmacies in Western Australia
Approved activity:
Supply of Schedule 4 oral antibiotics for uncomplicated urinary tract infection
Approved medicines:
Nitrofurantoin, Trimethoprim
Target population:
Female patients aged 18–65 with uncomplicated UTI
Conditions:
Compliance with training, registration, clinical criteria, record-keeping, and regulatory requirements
Date issued:
24 July 2023
Contact:
Medicines and Poisons Regulation Branch, [email protected]
Note:
, Number 034/7-2023
Year:
2021
Region / City:
United Kingdom
Topic:
Healthcare, Patient Care
Document Type:
Standard Operating Procedure (SOP)
Institution:
NHS
Author:
National Health Service (NHS)
Target Audience:
Healthcare professionals
Period of Application:
Indefinite
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / City:
Sacramento, California
Theme:
Public Utilities Commission, Regulatory Procedures, Utility Applications
Document Type:
Resolution
Institution / Organization:
Public Utilities Commission of the State of California
Author:
Public Utilities Commission of the State of California
Target Audience:
Utility companies, legal and regulatory professionals, public servants
Period of Validity:
Ongoing
Approval Date:
February 5, 2026
Amendment Date:
Not specified
Year:
2026
Region / City:
University of the Witwatersrand, South Africa
Subject:
Human Research Ethics
Document Type:
Application Form
Institution:
Human Research Ethics Committee (Medical)
Target Audience:
Researchers seeking ethics waiver
Purpose:
Postgraduate or investigator-initiated research without active human participation
Submission Method:
Email to Medical Ethics Office
Requirements:
Completion of all sections, typed form, ethics training certificate attached
Data Collection:
Not permitted before ethics clearance
Study Categories:
Literature review, in vitro study, microbiology, environmental surveillance, public observation
Applicant Roles:
Principal Investigator, Co-Investigator, Supervisor, Applicant
Endorsements:
Department/Unit Head, Academic or Clinical Head approval required
Guidelines Reference:
Appendix to the HREC (Medical) Application Form
Year:
2026
Institution:
University of Memphis Cecil C. Humphreys School of Law
Document Type:
Form
Audience:
Law students
Purpose:
Approval of student-initiated pro bono projects
Requirements:
Compliance with Pro Bono Handbook, prior approval before service
Submission:
Individual or group submission with participant list
Supervisor:
Anticipated organization supervisor contact information required
Project Scope:
Description of direct legal services and pro bono qualification
Training:
Indicate if training will be provided
Additional Notes:
Space for extra comments
Year:
2018
Region / City:
Victoria, Australia
Topic:
Education, Community Development
Document Type:
Guidelines
Organization:
Adult, Community and Further Education (ACFE) Board
Author:
ACFE Board
Target Audience:
Registered Learn Local Providers, Adult Education Institutions
Period of Validity:
2018-2019
Approval Date:
Not specified
Date of Changes:
Not specified
Country:
New Zealand
City:
Christchurch
Institution:
Christchurch Hospital
Organisation:
Nursing Council New Zealand; Canterbury District Health Board
Document Type:
Clinical agreement
Subject:
Nurse-initiated radiology referrals for adult patients
Healthcare Field:
Radiology; Nursing practice
Authorising Roles:
Clinical Director / Chief of Service; Chief of Radiology; Director of Nursing
Target Audience:
Clinical Nurse Specialists; Senior Medical Officers; Registered Medical Officers; Charge Nurse Managers; Radiologists; MRTs; Radiology nursing staff
Applicable Staff:
Registered Nurses and Nurse Practitioners registered with the Nursing Council New Zealand
Scope:
Adult patients within the specified hospital service
Associated Policies:
Midwife, Nurse Practitioner and Nurse Initiated Radiology Referrals Policy; CDHB Radiation Safety Plan
Associated Forms:
Diagnostic Radiology Consultation Form (QF00294); Interventional Radiology Consultation Form (QF01157)
Training Requirement:
CDHB healthLearn Nurse Midwife Radiology Referrals programme
Legal Reference:
Radiation Protection Act
Oversight:
Clinical Director of the service; Chief of Radiology; Director of Nursing
Audit Requirement:
Annual audit of nurse-initiated radiology referrals
Approval Process:
Clinical Director / Chief of Service; Chief of Radiology; Director of Nursing
Agreement Owner:
Clinical Director of the service; Director of Nursing
Authoriser:
Chief of Radiology (Principal Licence Holder)
Date of Authorisation:
dd month 20xx
Year:
20____
Region / City:
Randall County, Texas
Topic:
Legal Procedure
Document Type:
Motion
Organ / Institution:
Randall County District Court
Author:
[Attorney for Defendant]
Target Audience:
Legal Professionals, Court Officials
Period of Effectiveness:
From the date of approval
Date of Approval:
[DATE OF CASE ASSIGNMENT]
Date of Changes:
None indicated
Context:
This is a legal document requesting the appointment of a private investigator to assist a defendant in preparing a defense in a criminal case.
Note:
Year
Subject:
Clinical Trials, Medical Research
Document Type:
Template
Organization / Institution:
EU Clinical Trials Expert Group
Target Audience:
Sponsors of clinical trials
Note:
Year
Document type:
Checklist
Target audience:
Investigators, IRB staff
Context description:
A checklist for investigators and IRB staff to assess and ensure regulatory compliance in clinical and non-clinical research studies.
Year:
2025
Region / City:
Doha, Qatar
Topic:
Human Research Protection
Document Type:
Manual
Institution:
Virginia Commonwealth University
Author:
Huron Consulting Group
Target Audience:
Researchers, Investigators, Staff
Approval Date:
08/07/2025
Modification Date:
Not specified
Period of validity:
Not specified
Note:
Study Summary 1.1 Please provide a brief summary of the study in the table below. A complete description of the study with detailed information should be provided in the body of the protocol. For sections not applicable to the study, mark them as N/A. Study Title Study Design Primary Objective/Purpose Secondary Objective(s)/Purposes Research Intervention(s) ClinicalTrials.gov NCT # Study Population Sample Size Study Duration for individual subjects Study Specific Abbreviations/ Definitions
Background 3.1 Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. :
this section should be limited to only information directly related to the research questions and objectives. Do not include your full dissertation proposal. 3.2 Describe any relevant preliminary data (e.g. pilot data).
Procedures Involved 5.1 Describe and explain the study design. 5.2 Please select the methods that will be employed in this study (select all that apply):
☐ Audio/Video Recording ☐ Psychophysiological Recording ☐ Behavioral Interventions ☐ Record Review - Educational ☐ Behavioral Observations and Experimentations ☐ Record Review - Employee ☐ Deception ☐ Record Review- Medical ☐ Focus Groups ☐ Record Review - Other ☐ Interviews ☐ Specimen Collection or Analysis ☐ Investigational Medical Device – (e.g. Medical Mobile Applications) ☐ Surveys and/or Questionnaires ☐Psychometric Testing ☐ Other Social-Behavioral Procedures Provide a description of all research procedures being performed and when they are performed. (Upload any surveys, questionnaires, interview scripts, focus group scripts, debriefing scripts, psychometric tests, stimulus materials, intervention manuals, and data collection forms on the Local Site Documents page in the IRB application.) 5.3 Describe the procedures or interventions that are going to be conducted as part of the research project, but that would have been conducted anyway, even if the research was not occurring (i.e. standard of care procedures, activities that would occur in a classroom). 5.4 Describe the procedures performed to lessen the probability or magnitude of risks of items selected in 5.2.5. 5 If accessing or collecting existing data, describe: The data that will be collected during the study (e.g. demographics, medical history, etc.). Attach the data capture sheet(s) on the Local Site Documents page in the IRB application. How the data will be obtained, including how you have the authority to access the data. The source or location of the data (e.g. USF Epic, TGH Epic, Hillsborough County School records, CANVAS records, publicly available databases, etc.). 5.6 If collecting and/or analyzing biological specimens, describe: How the biological specimens will be or have been collected. How the biological specimens will be stored. How long the biological specimens will be stored. How the biological specimens will be used. The laboratories that will be used. Whether the collected biological specimens will undergo genetic testing. If so, indicate if this study is part of a Genome Wide Association Study (GWAS) and whether the data will be forwarded to the NIH dbGaP. 5.7 If there are plans for long-term follow-up (once all research related procedures are complete), what data will be collected during this period.
Data and Specimen Storage for Future Research 6.1 If data or specimens will be banked for future research studies, describe where the data or specimens will be stored, how long it/they will b:
the process to request a release, approvals required for release, who can obtain data or specimens, and the data to be provided with specimens.