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This document is a template for Sponsors of clinical trials to submit necessary information as part of an application dossier for clinical trials in accordance with EU Regulation No. 536/2014.
Note:
Year
Document type:
Template
Institution / organization:
EU Clinical Trials Expert Group
Target audience:
Sponsors of clinical trials
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The product description is provided for reference. Actual content and formatting may differ slightly.
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.
Year:
2025
Institution:
Yale University; Yale New Haven Health System
Document type:
Administrative request form
Subject area:
Human subjects research oversight
Regulatory framework:
U.S. federal human research protection regulations
Responsible body:
Institutional Review Board
Related system:
IRES IRB
Intended users:
Principal Investigators; Unaffiliated Investigators
Scope:
Authorization and oversight of unaffiliated investigators
Jurisdiction:
United States
Ethical standards referenced:
Belmont Report; HHS 45 CFR 46; FDA 21 CFR 50; HIPAA
Approval authority:
Yale/YNHHS Institutional Signatory Official
Note:
Year
Document Type:
Clinical Research Delegation Log
Author:
Principal Investigator / Investigator of Record
Target Audience:
Research Staff
Document type:
Agreement
Institution:
Oregon State University
Program:
Human Research Protection Program
Oversight body:
Institutional Review Board
Research area:
Human subjects research
Parties:
Individual Investigator; Oregon State University
Compliance framework:
International, federal, state, and local laws and regulations
Training requirements:
Research ethics training; CITI or equivalent
Approval requirement:
Institutional Review Board review and approval
Signature fields:
Investigator; HRPP Administrator
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:
2020
Region / City:
Tampa, Florida
Topic:
Human Subjects Research
Document Type:
Manual
Institution:
University of South Florida (USF)
Author:
USF Institutional Review Board
Target Audience:
Researchers and Investigators
Period of validity:
Ongoing from September 22, 2020
Approval Date:
September 22, 2020
Modification Date:
Not specified
Context:
A manual outlining procedures, regulations, and policies for conducting human subjects research at the University of South Florida, including requirements for IRB review and oversight.
Year:
Not specified
Region / City:
Maricopa County
Subject:
Law Enforcement, Criminal Investigations
Document Type:
Job Description
Agency:
Maricopa County Sheriff’s Office, Public Defender’s Office
Author:
Not specified
Target Audience:
Individuals seeking employment as investigators
Period of validity:
Not specified
Approval Date:
Not specified
Date of amendments:
Not specified
Year:
2026
Program:
NSF Research Traineeship (NRT)
Type of document:
Federal information collection request
Type of collection:
Customer satisfaction survey
Governing framework:
Generic Clearance for the Collection of Routine Customer Feedback
OMB Control Number:
3145-0215
Purpose:
Collection of customer satisfaction feedback on a principal investigator orientation webinar
Respondents:
Registered attendees of the NRT New PI orientation
Number of respondents:
21
Event date:
January 14, 2026
Data collection method:
Web-based survey via Google Forms
Personally identifiable information collected:
No
Incentives provided:
No
Estimated respondent burden:
4 hours
Estimated federal cost:
$200
Responsible organization:
National Science Foundation
Certifying official:
Suzanne H. Plimpton, NSF Reports Clearance Officer
Year:
20____
Region / City:
Bexar County, Texas
Subject:
Legal motion for the appointment of a private investigator
Document Type:
Court motion
Institution:
County Court, State of Texas
Author:
[DEFENDANT NAME]’s Attorney
Target Audience:
Legal professionals, court officials
Effective Period:
Not specified
Approval Date:
[DATE OF CASE ASSIGNMENT]
Amendment Date:
Not specified
Year:
2014
Region / City:
University of Cincinnati
Subject:
Informed consent for participation in medical research
Document type:
Research consent form
Organization / Institution:
University of Cincinnati
Author:
Principal Investigator, Research Team
Target audience:
Research participants
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Context:
Template for informed consent document for participation in biomedical or health-related research studies.
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