Regulatory Spot
Our commitment to responsible research starts with a solid foundation. The Regulatory Spot offers access to the essential documents that define ethical clinical research standards. We believe that informed professionals contribute to stronger research outcomes.
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ICH E6 (R3) Draft Guideline 20230519 (pdf)
Review the ICH GCP E6(R3) Draft Guidance to stay informed on evolving best practices in clinical trial conduct,ensuring compliance with the latest proposed regulatory expectations.
FDA Form 1572 (pdf)
Statement of Investigator (pdf) Access Form FDA 1572 (Statement of Investigator), a document outlining the qualifications and obligations of clinical investigators in FDA-regulated trials.
Summary of Health and Human Services HIPAA Privacy Rule (pdf)
The HIPAA Privacy Rule sets standards for protecting patient health information in research – access the full document here.
The Belmont Report (pdf)
The Belmont Report established core ethical guidelines for research with human subjects – download the full document here.
Essential Documents of a Clinical Trial (pdf)
Section 8 of ICH GCP defines essential documents necessary for conducting ethical and scientifically sound clinical trials – download the full section.
Declaration of Helsinki (pdf)
The Declaration of Helsinki champions patient rights and well-being in medical research – access the full guidelines here.
Document Retention Period (pdf)
Ensure research integrity and regulatory compliance:21 CFR 312.62 outlines the document retention period for clinical investigators.
Investigational New Drug Application (pdf)
The IND application, outlined in 21 CFR Part 312, is a cornerstone for safe and effective drug development by regulating clinical trials.
ICH GCP E6 (R2) Guidelines (pdf)
Download the ICH GCP E6(R2) guidelines (International Council for Harmonisation's Good Clinical Practice) – your essential reference for ethical and scientifically sound clinical research practices.
Applications for FDA Approval to Market a New Drug (pdf)
21 CFR Part 314 establishes ethical and regulatory standards for clinical trials, protecting participants and ensuring the integrity of research data on investigational new drugs.
HHS Policy for Protection of Human Subjects:Common Rule (pdf)
Subpart A of 45 CFR Part 46, also known as the Common Rule, sets forth ethical principles and regulations for protecting human subjects involved in research funded by the US Department of Health and Human Services (HHS).
Safety Events (pdf)
Promoting patient safety and data reliability, the ICH E6 (R2) guideline provides a standardized approach for managing and reporting adverse events in clinical research.
FDA Form 3455 - Financial Disclossure Form (pdf)
Promoting ethical research practices, FDA Form 3455 mandates disclosure of financial interests by clinical investigators to prevent potential conflicts of interest.
The Principles of ICH GCP (pdf)
The 13 principles of ICH GCP (E6 R2) establish ethical and scientific standards for the design, conduct, and reporting of clinical trials, ensuring the protection of human subjects and the integrity of trial data. Found in ICH GCP E6 R2.
IRB Requirements - 21 CFR Part 56 (pdf)
21 CFR Part 56 outlines the regulations governing Institutional Review Boards (IRBs), detailing their composition, functions, and procedures to ensure the protection of human subjects in research.
Transcelerate Biopharma - ICH GCP Training Requirements (pdf)
TransCelerate BioPharma specifies ICH GCP training requirements to ensure that clinical trial staff are proficient in international guidelines for ethical and scientific quality.
Investigator Responsibilities (pdf)
ICH GCP outlines investigator responsibilities to ensure ethical conduct, participant safety, and accurate data collection in clinical trials.