US Profile Updated in ClinRegs
The United States profile in ClinRegs has been reviewed and updated with the most current requirements. Key updates include:
-
Data protection requirements (See Quality, Data & Records Management)
-
Updated guidance on eCTD submissions (See Submission Process)
-
Additional supplemental resources related to cellular and gene therapy, investigator responsibilities, and safety reporting in Regulatory Authority, Trial Initiation, Safety Reporting, and Site/Investigator Selection
-
Food & Drug Administration processes for expedited review of drugs (See Timeline of Review)
Sources Added During this Update:
(Legislation) Health Insurance Portability and Accountability Act of 1996 (HIPAA) (August 20, 1996)
US Congress
(Regulation) Code of Federal Regulations - Title 45, Part 160 - General Administrative Requirements (45CFR160) (Up to Date as of January 13, 2022)
US Department of Health & Human Services
(Regulation) Code of Federal Regulations - Title 45, Part 164 – Security and Privacy (45CFR164) (Up to Date as of January 13, 2022)
US Department of Health & Human Services
(Guidance) Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection (G-IRBRpting) (January 2009)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects (G-InvstgtrResp) (October 2009)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff: Certificates of Confidentiality (G-CertCnfdntlty) (September 2020)
Food & Drug Administration, US Department of Health & Human Services
(Document) SOPP 8110: Submission of Regulatory Applications - Exempt from eCTD Requirements (USA-89) (Version 5) (Effective August 23, 2020)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Cellular & Gene Therapy Guidances (USA-80) (FDA reviewed December 10, 2021)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Contact OHRP (USA-82) (Last Reviewed March 3, 2016)
Office for Human Research Protections, US Department of Health & Human Services
(Webpage) Contact FDA (USA-81) (FDA reviewed April 7, 2020)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) HHS – Contact Us (USA-83) (Last Reviewed March 30, 2020)
US Department of Health & Human Services
(Webpage) Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review (USA-84) (FDA reviewed February 23, 2018)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Development & Approval Process - Drugs (USA-85) (FDA reviewed October 28, 2019)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Research (USA-86) (Last Reviewed June 13, 2018)
US Department of Health & Human Services
(Webpage) The HIPAA Privacy Rule (USA-87) (Last Reviewed December 7, 2021)
US Department of Health & Human Services
(Webpage) Office of Clinical Policy (USA-88) (FDA reviewed September 27, 2021)
Food & Drug Administration, US Department of Health & Human Services
Sources Revised During this Update:
(Guidance) eCTD Technical Conformance Guide (G-eCTDTech) (October 2021)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Transmitting Electronic Submissions Using eCTD Specifications (G-eCTDspecs) (Version 1.9) (June 14, 2021)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) IND Application Reporting: Safety Reports (USA-38) (FDA reviewed October 19, 2021)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Investigational New Drug Applications (INDs) for CBER-Regulated Products (USA-52) (FDA reviewed April 21, 2021)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Revised Common Rule Q&As (USA-54) (Last Reviewed December 1, 2021)
Office of Human Research Protections, US Department of Health & Human Services
(Webpage) Submission of an Investigational New Drug Application (IND) to CBER (USA-53) (FDA reviewed May 19, 2021)
Food & Drug Administration, US Department of Health & Human Services