№ lp_1_20189
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This SOP outlines the process for reporting and assessing Reportable Negative Events (RNEs) in nonclinical research studies, ensuring the safety and welfare of human participants and research team members.
Year: 2026
Region / City: International
Theme: Research Ethics
Document Type: Standard Operating Procedure (SOP)
Organ / Institution: ISU-IREB
Author: ISU-IREB SOP Team
Target Audience: Researchers, IREB Members
Period of Validity: Ongoing
Approval Date: 2026-02-03
Date of Changes: N/A
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Policy Statement on ISU-IREB Site Visits
Year: 2023
Region / City: N/A
Topic: Research Ethics, Site Visits
Document Type: Policy Statement
Organization / Institution: ISU-IREB
Author: N/A
Target Audience: Researchers, Ethics Review Boards
Effective Period: N/A
Approval Date: October 24, 2023
Revision Date: N/A
Validation Checklist for Type II (non)clinical variations
Note: Year
V1.1 Nonclinical Study Report Template for RepeatDose Toxicology Studies
Year: 2021
Region / city: N/A
Subject area: Toxicology
Document type: Template
Author: BioCelerate
Target audience: Researchers, regulatory professionals
Period of validity: N/A
Approval date: N/A
Amendment date: N/A
Responses to the applicant’s documentation for the quality, nonclinical, and clinical aspects of a medicinal product submission
Year: 2026
Region / city: N/A
Subject: Pharmaceutical regulatory submission
Document type: Submission guidelines
Authority / institution: N/A
Author: N/A
Target audience: Applicants for pharmaceutical submissions
Validity period: N/A
Approval date: N/A
Amendment date: N/A
Validation Checklist for Type II (non)clinical variations
Note: Year
Contextual description: A checklist for the submission of variations related to type II clinical and non-clinical changes to product information in the European market.
V1.1 Nonclinical Study Plan/Protocol Template for Repeat-Dose Toxicology Studies
Year: N/A
Region / City: N/A
Subject: Toxicology Study Plan/Protocol
Document Type: Template
Organization / Institution: BioCelerate
Author: N/A
Target Audience: Researchers, Sponsors, and CROs involved in nonclinical studies
Period of Validity: N/A
Approval Date: N/A
Modification Date: N/A
Regulatory Guidance for Module 2.4 Nonclinical Overview (Common Technical Document)
Document Type: Regulatory guidance
Module: 2.4 Nonclinical Overview
Framework: Common Technical Document (CTD)
Related Guideline: M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Note: Related Guideline Guidance for Industry M4S: The CTD — Safety
Subject: Nonclinical testing strategy, pharmacology, pharmacokinetics, and toxicology
Intended Application: Registration of pharmaceuticals for human use
Referenced Standards: Good Laboratory Practice (GLP)
Scope: Evaluation of pharmacologic, pharmacokinetic, toxicologic, and impurity data
Topics: RNEs ISU-IREB nonclinical