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A list of all pages that have property "DocDescription" with value "STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9". Since there have been only a few results, also nearby values are displayed.

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  • Document:ICH ICH E3 Guideline 1995  + (STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS)
  • Document:ICH ICH E7 Guideline 1993  + (STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS)
  • Document:FRA SI RIPH 2G - Website 16-May-2025  + (Soumission CPP Ă  rĂ©aliser via la plateforme centralisĂ©e avec tirage au sort du CPP)
  • Document:DEU SGB V - Sozialgesetzbuch FĂĽnftes Buch 20-Dez-1988  + (Sozialgesetzbuch (SGB) FĂĽnftes Buch (V) - Gesetzliche Krankenversicherung - (Artikel 1 des Gesetzes v. 20. Dezember 1988, BGBl. I S. 2477))
  • Document:EU CHMP Guidelines -  + (The Committee for Medicinal Products for H … The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.</br></br>Clinical efficacy and safety guideline categories :</br>- Alimentary tract and metabolism</br>- Blood and blood forming organs</br>- Blood products (including biotechnological alternatives)</br>- Cardiovascular system</br>- Dermatologicals</br>- Genito-urinary system and sex hormones</br>- Anti-infectives for systemic use</br>- Antineoplastic and immunomodulating agents</br>- Rheumatology/musculoskeletal system</br>- Nervous system</br>- Respiratory system</br>- Orally inhaled products</br>- Radiopharmaceuticals and diagnostic agents</br>- Allergy/Immunology</br>- Biostatistics</br>- General (Including ICH guidelines E1 </br></br>To be noted:</br>- INS/GCP/46309/2012 – Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMPtions conducted at the request of the CHMP)
  • Document:CIOMS CIOMS Publications -  + (The Council for International Organization … The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.</br></br>Selection of publications:</br></br>- Clinical research in resource-limited settings (2021)</br>- Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA – Second Edition (2016)</br>- Practical Approaches to Risk Minimisation for Medicinal Products: Report of CIOMS Working Group IX (2014)</br>- International Ethical Guidelines for Epidemiological Studies (2009)</br>- Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials: Report of CIOMS Working Group VII (2006)</br>- International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)l Research Involving Human Subjects (2002))
  • Document:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019  + (The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019)
  • Document:GBR The Human Medicines Regulations 2012 01-Jan-2025  + (The Human Medicines Regulations 2012)
  • Document:GBR The Medical Devices Regulations 2002 11-Feb-2021  + (The Medical Devices Regulations 2002)
  • Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004  + (The Medicines for Human Use (Clinical Trials) Regulations 2004)
  • Document:GBR NHS: Records Management Code of Practice 07-Aug-2023  + (The Records Management Code of Practice fo … The Records Management Code of Practice for Health and Social Care (from this point onwards referred to as the Code) is a guide for you to use in relation to the practice of managing records. It is relevant to organisations working within, or under contract to, the NHS in England. or under contract to, the NHS in England.)
  • Document:USA 21 CFR Part 11 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 11 Electronic Records; Electronic Signatures https://www.ecfr.gov/current/title-21)
  • Document:USA 21 CFR Part 54 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 54 Financial Disclosure by Clinical Investigators https://www.ecfr.gov/current/title-21)
  • Document:USA 21 CFR Part 50 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 50 Protection of Human Subjects https://www.ecfr.gov/current/title-21)
  • Document:USA 21 CFR Part 56 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 56 Institutional Review Boards https://www.ecfr.gov/current/title-21)
  • Document:USA 21 CFR Part 812 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter H—Medical Devices Part 812 Investigational Device Exemptions https://www.ecfr.gov/current/title-21)
  • Document:USA 21 CFR Part 314 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 314 Applications for FDA Approval to Market a New Drug https://www.ecfr.gov/current/title-21)
  • Document:USA 21 CFR Part 320 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 320 Bioavailability and Bioequivalence Requirements https://www.ecfr.gov/current/title-21)
  • Document:USA 21 CFR Part 312 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21)
  • Document:USA 42 CFR Part 11 09-Apr-2025  + (Title 42—Public Health Chapter I—Public Health Service, Department of Health and Human Services Subchapter A—General Provisions Part 11 Clinical Trials Registration and Results Information Submission https://www.ecfr.gov/current/title-42)
  • Document:USA 45 CFR Part 160 09-Apr-2025  + (Title 45—Public Welfare Subtitle A—Department of Health and Human Services Subchapter C—Administrative Data Standards and Related Requirements Part 164 Security and Privacy https://www.ecfr.gov/current/title-45)
  • Document:USA 45 CFR Part 46 09-Apr-2025  + (Title 45—Public Welfare Subtitle A—Department of Health and Human Services Subchapter A—General Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45)
  • Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025  + (Transcelerate GCP mutual recognition programm FAQ)
  • Document:INT Nuremberg Code 1947  + (Trials of War Criminals Before the Nuernberg Military Tribunals Under Control Council Law No. 10, Nuremberg, October 1946-April, 1949: Case 1: U.S. v. Brandt (cont.) Case 2. U.S. v. Milch (Milch case) Page 181 - 182)
  • Document:USA U.S. Code Title 21 30-Sep-2023  + (U.S. Code Title 21 - Food and Drugs)
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