ichgcp.net

• equiv: origin-trial content: A7vZI3v+Gz7JfuRolKNM4Aff6zaGuT7X0mf3wtoZTnKv6497cVMnhy03KDqX7kBz/q/iidW7srW31oQbBt4VhgoAAACUeyJvcmlnaW4iOiJodHRwczovL3d3dy5nb29nbGUuY29tOjQ0MyIsImZlYXR1cmUiOiJEaXNhYmxlVGhpcmRQYXJ0eVN0b3JhZ2VQYXJ0aXRpb25pbmczIiwiZXhwaXJ5IjoxNzU3OTgwODAwLCJpc1N1YmRvbWFpbiI6dHJ1ZSwiaXNUaGlyZFBhcnR5Ijp0cnVlfQ==
• equiv: Content-Type content: text/html; charset=UTF-8
• name: description content: ICH GCP - GOOD CLINICAL PRACTICE (GCP) E6(R3) Step 5. Date for coming into effect 23 July 2025. ICH E6(R3) introduces innovative provisions designed to apply across various types and settings of clinical trials, ensuring continued relevance in the face of ongoing technological and methodological advancements. This guideline provides a new language to facilitate innovations in clinical trial design, technology, and operational approaches. It encourages a risk-based and proportionate approach to conducting clinical trials, promoting fit-for-purpose solutions. It fosters transparency through clinical trial registration and result reporting and offers additional guidance to enhance the informed consent process.​
• name: keywords content: ICH GCP - good clinical practice, GOOD CLINICAL PRACTICE (GCP) E6(R3) Step 5, ICH E6(R1), ICH E6(R2), ICH GCP, ICH GCP E6(R2), 23 January 2025, Date for coming into effect 23 July 2025, decentralised, real-world, pragmatic, investigator, sponsor, protocol, investigator's brochure, trial design, safety reporting, informed consent, statistics, ethics committee, clinical study/trial report, clinical trials, innovation, design., ICH GCP
• name: viewport content: width=device-width, initial-scale=1.0
• name: msapplication-TileColor content: #da532c
• name: theme-color content: #3f967c
• property: og:title content: ICH harmonised guideline: ICH E6 (R3) Guideline on good clinical practice (GCP)_main
• property: og:type content: article
• property: og:url content: https://ichgcp.net/ich-harmonised-guideline-ich-e6-r3-guideline-on-good-clinical-practice-gcp-main
• property: og:description content: ...
• property: og:site_name content: ICHGCP
• property: og:locale content: en
• equiv: origin-trial content: AlK2UR5SkAlj8jjdEc9p3F3xuFYlF6LYjAML3EOqw1g26eCwWPjdmecULvBH5MVPoqKYrOfPhYVL71xAXI1IBQoAAAB8eyJvcmlnaW4iOiJodHRwczovL2RvdWJsZWNsaWNrLm5ldDo0NDMiLCJmZWF0dXJlIjoiV2ViVmlld1hSZXF1ZXN0ZWRXaXRoRGVwcmVjYXRpb24iLCJleHBpcnkiOjE3NTgwNjcxOTksImlzU3ViZG9tYWluIjp0cnVlfQ==
• equiv: origin-trial content: Amm8/NmvvQfhwCib6I7ZsmUxiSCfOxWxHayJwyU1r3gRIItzr7bNQid6O8ZYaE1GSQTa69WwhPC9flq/oYkRBwsAAACCeyJvcmlnaW4iOiJodHRwczovL2dvb2dsZXN5bmRpY2F0aW9uLmNvbTo0NDMiLCJmZWF0dXJlIjoiV2ViVmlld1hSZXF1ZXN0ZWRXaXRoRGVwcmVjYXRpb24iLCJleHBpcnkiOjE3NTgwNjcxOTksImlzU3ViZG9tYWluIjp0cnVlfQ==
• equiv: origin-trial content: A9nrunKdU5m96PSN1XsSGr3qOP0lvPFUB2AiAylCDlN5DTl17uDFkpQuHj1AFtgWLxpLaiBZuhrtb2WOu7ofHwEAAACKeyJvcmlnaW4iOiJodHRwczovL2RvdWJsZWNsaWNrLm5ldDo0NDMiLCJmZWF0dXJlIjoiQUlQcm9tcHRBUElNdWx0aW1vZGFsSW5wdXQiLCJleHBpcnkiOjE3NzQzMTA0MDAsImlzU3ViZG9tYWluIjp0cnVlLCJpc1RoaXJkUGFydHkiOnRydWV9
• equiv: origin-trial content: A93bovR+QVXNx2/38qDbmeYYf1wdte9EO37K9eMq3r+541qo0byhYU899BhPB7Cv9QqD7wIbR1B6OAc9kEfYCA4AAACQeyJvcmlnaW4iOiJodHRwczovL2dvb2dsZXN5bmRpY2F0aW9uLmNvbTo0NDMiLCJmZWF0dXJlIjoiQUlQcm9tcHRBUElNdWx0aW1vZGFsSW5wdXQiLCJleHBpcnkiOjE3NzQzMTA0MDAsImlzU3ViZG9tYWluIjp0cnVlLCJpc1RoaXJkUGFydHkiOnRydWV9
• equiv: origin-trial content: A1S5fojrAunSDrFbD8OfGmFHdRFZymSM/1ss3G+NEttCLfHkXvlcF6LGLH8Mo5PakLO1sCASXU1/gQf6XGuTBgwAAACQeyJvcmlnaW4iOiJodHRwczovL2dvb2dsZXRhZ3NlcnZpY2VzLmNvbTo0NDMiLCJmZWF0dXJlIjoiQUlQcm9tcHRBUElNdWx0aW1vZGFsSW5wdXQiLCJleHBpcnkiOjE3NzQzMTA0MDAsImlzU3ViZG9tYWluIjp0cnVlLCJpc1RoaXJkUGFydHkiOnRydWV9
• equiv: origin-trial content: AlK2UR5SkAlj8jjdEc9p3F3xuFYlF6LYjAML3EOqw1g26eCwWPjdmecULvBH5MVPoqKYrOfPhYVL71xAXI1IBQoAAAB8eyJvcmlnaW4iOiJodHRwczovL2RvdWJsZWNsaWNrLm5ldDo0NDMiLCJmZWF0dXJlIjoiV2ViVmlld1hSZXF1ZXN0ZWRXaXRoRGVwcmVjYXRpb24iLCJleHBpcnkiOjE3NTgwNjcxOTksImlzU3ViZG9tYWluIjp0cnVlfQ==
• equiv: origin-trial content: Amm8/NmvvQfhwCib6I7ZsmUxiSCfOxWxHayJwyU1r3gRIItzr7bNQid6O8ZYaE1GSQTa69WwhPC9flq/oYkRBwsAAACCeyJvcmlnaW4iOiJodHRwczovL2dvb2dsZXN5bmRpY2F0aW9uLmNvbTo0NDMiLCJmZWF0dXJlIjoiV2ViVmlld1hSZXF1ZXN0ZWRXaXRoRGVwcmVjYXRpb24iLCJleHBpcnkiOjE3NTgwNjcxOTksImlzU3ViZG9tYWluIjp0cnVlfQ==
• equiv: origin-trial content: A9nrunKdU5m96PSN1XsSGr3qOP0lvPFUB2AiAylCDlN5DTl17uDFkpQuHj1AFtgWLxpLaiBZuhrtb2WOu7ofHwEAAACKeyJvcmlnaW4iOiJodHRwczovL2RvdWJsZWNsaWNrLm5ldDo0NDMiLCJmZWF0dXJlIjoiQUlQcm9tcHRBUElNdWx0aW1vZGFsSW5wdXQiLCJleHBpcnkiOjE3NzQzMTA0MDAsImlzU3ViZG9tYWluIjp0cnVlLCJpc1RoaXJkUGFydHkiOnRydWV9
• equiv: origin-trial content: A93bovR+QVXNx2/38qDbmeYYf1wdte9EO37K9eMq3r+541qo0byhYU899BhPB7Cv9QqD7wIbR1B6OAc9kEfYCA4AAACQeyJvcmlnaW4iOiJodHRwczovL2dvb2dsZXN5bmRpY2F0aW9uLmNvbTo0NDMiLCJmZWF0dXJlIjoiQUlQcm9tcHRBUElNdWx0aW1vZGFsSW5wdXQiLCJleHBpcnkiOjE3NzQzMTA0MDAsImlzU3ViZG9tYWluIjp0cnVlLCJpc1RoaXJkUGFydHkiOnRydWV9
• equiv: origin-trial content: A1S5fojrAunSDrFbD8OfGmFHdRFZymSM/1ss3G+NEttCLfHkXvlcF6LGLH8Mo5PakLO1sCASXU1/gQf6XGuTBgwAAACQeyJvcmlnaW4iOiJodHRwczovL2dvb2dsZXRhZ3NlcnZpY2VzLmNvbTo0NDMiLCJmZWF0dXJlIjoiQUlQcm9tcHRBUElNdWx0aW1vZGFsSW5wdXQiLCJleHBpcnkiOjE3NzQzMTA0MDAsImlzU3ViZG9tYWluIjp0cnVlLCJpc1RoaXJkUGFydHkiOnRydWV9

• https://ichgcp.net
• Privacy policy
• ICH GCP (De)
• TABLE OF CONTENTS
• ICH GCP (Es)
• ICH GCP (Fr)
• ICH GCP (It)
• ICH GCP (Pt)
• ICH GCP (Ru)
• USA (FDA)
• UK (MHRA)
• AUSTRALIA (NHMRC)
• JAPAN (PMDA)
• EU (EMA)
• CRO List
• US Clinical Trials Registry
• EU Clinical Trials Registry
• Pharmaceutical Companies
• Clinical Research Labs
• Service Companies
• Clinical Research Events
• Publications
• Researchers
• Jobs
• Publications
• News
• I. INTRODUCTION
• II. PRINCIPLES OF ICH GCP
• III.  ANNEX 1
• 1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
• 2.  INVESTIGATOR 
• 3. SPONSOR
• 4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR
• Appendix A. INVESTIGATOR’S BROCHURE
• Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
• Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
• GLOSSARY
• https://ichgcp.net/news/applying-for-a-paediatric-investigation-plan-pip-review-of-the-ema-guidelines
• https://ichgcp.net/news/considerations-for-the-use-of-real-world-data-and-real-world-evidence-to-support-regulatory-decision-making-for-drug-and-biological-products
• https://ichgcp.net/news/the-study-of-the-new-investigational-drug-for-acute-myeloid-leukemia-and-myelodysplastic-syndrome
• https://ichgcp.net/news/open-label-study-of-entrectinib-in-ros1-gene-fusion-positive-rare-adult-paediatric-and-teenage-young-adult-tya-cancers
• https://ichgcp.net/news/randomized-double-blind-placebo-controlled-phase-1b-study-of-gsbr-1290-in-adult-overweight-or-obese-healthy-subjects
• https://ichgcp.net/news/a-study-of-dexpramipexole-in-adolescents-and-adults-with-severe-eosinophilic-asthma-exhale-2
• https://ichgcp.net/news/study-of-safety-and-pharmacokinetics-of-do-2-in-patients-with-advanced-or-refractory-solid-tumours
• Breast Cancer PSMA PET
• A Dose-exploration Study of EDP167 in HoFH
• GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
• NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
• Arthrosemid vs. Steroid for the Management Knee Osteoarthritis
• Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy
• Metabolomic Pathways and Traditional Chinese Medicine Body Constitution in Cancer-related Fatigue
• A Study to Evaluate D-2570 in Participants With Moderate to Severe Plaque Psoriasis (N/Z)
• Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement. (LCPTG)
• IIT2025-03-YANG-LIFT-HCC
• Phase 3 Bunionectomy Study
• At-Home Paracentesis for Women With Cancer-Related Malignant Ascites (Paracentesis) (Paracentesis)
• https://ichgcp.net/jobs/40463-quality-assurance-auditor
• PSI
• https://ichgcp.net/jobs/40457-fsp-cra-ii
• PPD
• https://ichgcp.net/jobs/40525-clinical-monitoring-intern-summer-2026
• Medpace
• https://ichgcp.net/jobs/40533-country-study-operations-manager-france-home-based-fsp
• Parexel
• https://ichgcp.net/jobs/40531-global-segment-marketing-manager-pharma-biotech-remote
• Charles River Laboratories
• https://ichgcp.net/jobs/40529-cra-ii
• Fortrea
• https://ichgcp.net/jobs/40492-site-activation-specialist-japan-remote
• Worldwide Clinical Trials
• https://ichgcp.net/jobs/40526-car-t-associate-scientist
• Eurofins Optimed
• https://ichgcp.net/jobs/40391-associate-resource-management
• Ergomed
• https://ichgcp.net/jobs/38429-principal-statistical-r-programmer-north-america-only
• Syneos Health
• https://ichgcp.net/jobs/31383-hr-business-partner
• IQVIA
• More jobs
• Assiut University
• Cairo University
• GlaxoSmithKline
• National Cancer Institute (NCI)
• Assistance Publique - Hôpitaux de Paris
• AstraZeneca
• Pfizer
• Mayo Clinic
• M.D. Anderson Cancer Center
• Novartis Pharmaceuticals
• National Taiwan University Hospital
• Massachusetts General Hospital
• National Institute of Allergy and Infectious Diseases (NIAID)
• Boehringer Ingelheim
• Merck Sharp & Dohme LLC
• University of California, San Francisco
• Stanford University
• Hoffmann-La Roche
• Eli Lilly and Company
• Duke University
• View Full List
• Breast Cancer
• Obesity
• Stroke
• Hypertension
• Depression
• Pain
• Prostate Cancer
• Cancer
• HIV Infections
• Coronary Artery Disease
• Heart Failure
• Asthma
• Colorectal Cancer
• Diabetes Mellitus, Type 2
• Anxiety
• Lung Cancer
• Cardiovascular Diseases
• Diabetes
• COVID-19
• Schizophrenia
• View Full List
• Cyclophosphamide
• Cisplatin
• Carboplatin
• Paclitaxel
• Dexamethasone
• Docetaxel
• Gemcitabine
• Bevacizumab
• Metformin
• Pembrolizumab
• Capecitabine
• Oxaliplatin
• Prednisone
• Methotrexate
• Rituximab
• Etoposide
• Dexmedetomidine
• Fludarabine
• Cytarabine
• Propofol
• View Full List
• English
• EU (EMA)
• Jobs
• About us / Our mission
• Sitemap
• Contact us
• RSS feed
• Privacy Policy
• Disclaimer
• Dansk
• Deutsch
• Español
• Français
• Italiano
• Magyar
• Nederlands
• Norsk
• Polski
• Português
• Suomi
• Svenska
• Čeština
• Русский
• 日本語
• 简体中文
• 한국어
• [email protected]

            Domain Name: ICHGCP.NET
Registrar: GoDaddy.com, LLC
Domain Status: client delete prohibited
Domain Status: client renew prohibited
Domain Status: client transfer prohibited
Domain Status: client update prohibited
Creation Date: 2008-09-26T16:16:23Z
Registry Expiry Date: 2032-09-26T16:16:23Z
Updated Date: 2023-03-05T07:28:55Z
Name Server: JESSICA.NS.CLOUDFLARE.COM
Name Server: WOZ.NS.CLOUDFLARE.COM
REGISTRAR Contact: GoDaddy.com, LLC
>>> Last update of RDAP database: 2026-07-31T04:07:35Z         

			User-agent: *
Allow: /

        

Technické SEO

SEO na stránce

Obsah a UX