FDA Circular No. ____ Subject: Guidelines on the Classification of Deficiencies Observed During Inspection of the Conduct of Clinical Trials

Other (TBT)

Pharmaceutics (ICS code(s): 11.120)

Link to ePing

11.120 - Pharmaceutics

Human health

These guidelines shall apply to Sponsors, Clinical Research Organizations (CROs), Investigators, and Research Ethics Committees (RECs), and other stakeholders involved in the approval, conduct, monitoring and inspection, in all phases of clinical trials for Investigational Pharmaceutical Products to ensure that the rights, safety, and well-being of study subjects have been protected, to ensure integrity of the scientific data collected and to assess adherence to the International Council on Harmonization of Good Clinical Practices (ICH-GCP) Principles. These guidelines shall also apply to Good Clinical Practice (GCP) inspectorate service of the FDA’s Field Regulatory Operations Office (FROO) for uniformity of regulatory understanding and implementation of the classification of deficiencies/non-conformances observed in the conduct of inspection of the different phases of a clinical trial for investigational products. And to establish a consistent understanding of the compliance requirements for all stakeholders, as prescribed by R.A. No. 3720, as amended by R.A. No. 9711, R.A. No. 11032, A.O. 2020-0010, and pertinent national and international standards and policies.

1:File here 2:File here

EN:File here

FR:File here

ES:File here

Active Inactive