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This document is a pre-review checklist for submissions to the IRB, detailing the necessary steps for HRPO staff to assess completeness, regulatory compliance, and administrative considerations in clinical research protocols.
Note:
Year
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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.
Note:
Year
Topic:
Procurement, Equipment, Services, Software
Document Type:
Checklist
Organization:
County APD
Year:
2023
State:
Wisconsin
Type of Document:
Questionnaire / Data Collection Form
Institution:
Department of Health Services, Division of Public Health
Program:
Trauma Program
Target Audience:
Hospitals seeking Level IV trauma classification
Reporting Period:
12 months prior to PRQ submission
Submission Deadline:
45 days before scheduled site visit
Contact Email:
[email protected]
HRP-308 Worksheet: Pre-Review Screening Checklist for Human Research Submissions (February 16, 2026)
Year:
2026
Date:
February 16, 2026
Document Code:
HRP-308
Document Type:
Worksheet
Subject:
Human Research Ethics Review and IRB Pre-Review Screening
Responsible Body:
Institutional Review Board (IRB)
Purpose:
Screening of submission materials for Human Research review
Related Documents:
HRP-309 Ancillary Review Matrix; HRP-330 HIPAA Authorization Worksheet; HRP-024 SOP New Information; HRP-306 Drugs Worksheet; HRP-307 Devices Worksheet; HRP-801 Establishing Reliance Agreements; HRP-815 Institutional Profile Form; HRP-830 Communication and Responsibilities Worksheet
Regulatory Areas Referenced:
Human Research Regulations; EU GDPR; HIPAA; NIH Policy; FERPA; PPRA
Primary Users:
IRB staff conducting submission screening
Scope:
Initial review, modification review, and pSite review for studies relying on the IRB
Key Topics:
regulatory oversight determination, ancillary reviews, ethics training verification, conflict of interest disclosure, consent documentation, research protocol completeness, drug and device oversight, multi-site research coordination, HIPAA authorization review, protection of vulnerable populations
Note:
Year
Context:
This document outlines the process for Clinical Faculty to complete a Pre-Review of Payroll Statements in the PAC system for certification.
Year:
2024
Region / city:
Edinburgh, UK
Topic:
Genetics of Mortality in Critical Care
Document Type:
Study Protocol
Organization / Institution:
University of Edinburgh, NHS Lothian Health Board
Author:
Prof JK Baillie, Ms F Griffiths, Dr S Clohisey, Dr A Law, Dr N Parkinson, Mr L Murphy, Mr Edward Rippingale-Combes
Target Audience:
Researchers, Healthcare professionals
Duration:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Cincinnati
Subject:
Social and Behavioral Sciences Research
Document Type:
Research Protocol Submission Guidelines
Institution / Organization:
University of Cincinnati
Author:
Not specified
Target Audience:
Researchers submitting to the IRB-S
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
United States
Theme:
Racial and gender discrimination, military climate, sexual harassment, sexual assault
Document Type:
Research Protocol
Organization / Institution:
Department of Defense, Office of People Analytics (OPA)
Author:
Unknown
Target Audience:
Racial/ethnic minority service members in the U.S. military
Period of Action:
2023
Approval Date:
Unknown
Date of Changes:
Unknown
Version:
1.5.0.0
Protocol Posting Date:
June 2024
CAP Laboratory Accreditation Program Protocol Required Use Date:
March 2025
Authors:
Gulisa Turashvili, MD, PhD; Uma G. Krishnamurti, MD, PhD; Barbara A. Crothers, DO; Giovanna A. Giannico, MD; Krisztina Hanley, MD; Anna Plotkin, MD; Anthony N. Karnezis, MD, PhD.
Note:
Accreditation Requirements
Date of Protocol Posting:
June 2024
Date of Required Use:
March 2025
Year:
2025
Date:
September 11, 2025
Version:
v1.1
Document type:
Research report
Author:
Edgar Marcelo Quiroz Robles
Affiliation:
Independent Researcher
Field:
Theoretical cosmology and mathematical physics
Framework:
4-Dimensional Elastic Model of the Universe (4DEM)
Related theories:
String theory
Status:
Draft
Repository:
Zenodo
Publication note:
Extended appendices published as Amazon KDP eBooks
Note:
Year
Year:
2026
Version:
NENC v2.0
Date published:
22 January 2026
Planned review date:
October 2027
Region:
North East and North Cumbria
Healthcare system:
NHS
Clinical area:
Neurology
Condition:
Amyotrophic lateral sclerosis
Medicine:
Riluzole
Document type:
Shared care protocol
Indication:
Extension of survival or time to mechanical ventilation in ALS
Target population:
Adults
Intended audience:
NHS healthcare professionals
Initiating authority:
Neurological specialist services
Regulatory reference:
NICE Technology Appraisal TA20
Prescribing setting:
Secondary to primary care transfer
Monitoring requirements:
Liver function tests, full blood count, urea and electrolytes
Route of administration:
Oral or enteral
Licensing status:
Licensed for ALS only
Investigator:
[insert name of principal investigator]
Key Information:
The following is a short summary of this study to help you decide whether or not to be a part of this study. More detailed information is listed later on in this form.
Note:
Why am I being invited to take part in a research study?
You will be asked to _________ [include a high level summary of the procedures that will be done. For example:
You will be given an investigational drug and asked to come for 3 study visits. You will give a total of 3 blood samples and fill out questionnaires asking about how you feel.]
Instead of being in this research study, your choices may include:
[List alternatives procedures. For student subject pools describe alternatives for course credit. For clinical trials describe the options that you would normally offer patient. If applicable, include supportive care as an option.]
Detailed Information:
The following is more detailed information about this study in addition to the information listed above.
[Tell the subject what to expect using lay language and simple terms. Whenever appropriate include the following items:
]
Year:
2020
Type of Document:
Protocol
Organization:
XXXX
Target Audience:
Leadership, Crisis Management Team
Scope:
International
Update Date:
October 2020
Document Sections:
Definitions, Purpose, Crisis Management Team, Escalation Levels, Phases, Strategy, Logs, After-Action Review, Annexures
Note:
Year
Year:
2025
Region / City:
London
Topic:
Neonatal BCG vaccination program
Document Type:
Protocol
Organization / Institution:
NHSE
Author:
Alice Waters
Target Audience:
Healthcare professionals involved in neonatal care and immunization
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
September 2025
Year:
2022
Region / City:
Cheshire and Merseyside
Subject:
Child Protection, Family Law
Document Type:
Practice Note
Issuing Authority:
His Honour Judge Steven Parker, Designated Family Judge for Cheshire and Merseyside
Period of Application:
2022-2023 (pilot phase)
Approval Date:
9th March 2022
Amendment Date:
None
Note:
Date of Application
Year:
2025
Region / city:
United Kingdom
Subject:
COVID-19 vaccination
Document type:
Protocol
Institution:
UK Health Security Agency (UKHSA)
Author:
UK Health Security Agency (UKHSA)
Target audience:
Healthcare providers involved in COVID-19 vaccination
Period of validity:
1 October 2025 – 31 January 2026
Approval date:
12 September 2025
Note:
Revision history