- Oversight of Clinical Investigations — A Risk|Based Approach🔍
- Clinical Trials Guidance Documents🔍
- Guidance for best practices for clinical trials🔍
- Clinical investigations guidance🔍
- MDCG 2024|3 Guidance on content of the Clinical Investigation ...🔍
- FDA Finalizes Guidance on Informed Consent for Clinical ...🔍
- FDA guidance and regulations🔍
- Digital Health Technologies for Remote Data Acquisition in Clinical ...🔍
Clinical investigations guidance
Oversight of Clinical Investigations — A Risk-Based Approach - FDA
This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical ...
Clinical Trials Guidance Documents | FDA
Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject ...
Guidance for best practices for clinical trials
This guidance updates and adapts the previous work of the World Health Organization (WHO) on research capacity for the context of ...
Clinical investigations guidance - GOV.UK
You must inform the MHRA if you are planning to do this at least 60 days before starting your investigation.
MDCG 2024-3 Guidance on content of the Clinical Investigation ...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed ...
FDA Finalizes Guidance on Informed Consent for Clinical ...
Enrollment in Multiple Investigations: As in the Draft Guidance, FDA discourages concurrent enrollment of a subject in more than one clinical ...
Clinical trials involving investigational drugs, biologics and/or devices are governed by specific FDA regulations. Numerous parties involved in ...
Digital Health Technologies for Remote Data Acquisition in Clinical ...
The guidance represents the current thinking of FDA on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” It ...
NIH and Other Federal Guidelines & Policies for Clinical Research
Read guidelines for high-quality, safe, and ethical clinical research from the NIH, FDA, OHRP, and other Federal agencies.
FDA Guidance on Conduct of Clinical Trials of Medical Products ...
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented ...
Oversight of Clinical Investigations — A Risk-Based Approach to ...
This guidance makes clear that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring clinical investigator (CI) conduct and ...
Guidance for Industry - E6 Good Clinical Practice
The principles established in this guidance may also be applied to other clinical investigations that ... The terms clinical trial and clinical study are ...
100. Overview of FDA Regulations, Information Sheets and Guidance
Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be ...
Clinical Research Regulation For United States | ClinRegs
Summary of United States clinical research requirements and relevant sources related to regulatory authority, ethics committees, submission process, ...
guidelines on medical devices guidelines on clinical investigation: a ...
is not intended to provide comprehensive guidance for clinical investigations of specific medical devices. The guidance contained within this document is ...
FDA publishes final question-and-answer guidance on a risk-based ...
Although clinical investigations must be monitored, the FDA provides flexibility in how to do so. The guidance provides recommendations on ...
Find upcoming IRB trainings and workshops. The clinical trials management system, Study Tracking and Analysis for Research (STAR), training is provided by the ...
Applications are submitted electronically using the Integrated Research Application. System (IRAS). Page 14. MHRA. Guidance on legislation. Clinical ...
Draft Guidance for Industry, Clinical Investigators, and Institutional ...
If different guidance should apply to social and behavioral research, or other non-FDA-regulated studies, OHRP asks that the public comments ...
Three of a Kind: FDA Guidance Documents Provide ...
This guidance is intended to support the conduct of clinical trials with streamlined protocols and procedures that focus on essential data ...