ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the rights, safety and wellbeing of the trial subjects are protected. Ensure the credibility of clinical trial data.
TABLE OF CONTENTS
1. GLOSSARY
3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
4. INVESTIGATOR
5. SPONSOR
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Upcoming Clinical Trials
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NCT05637138RecruitingHealthy Volunteers, Pathologies for Which paCO2 Monitoring is Crucial, Particularly in the Context of Chronic Obstructive Pulmonary Disease (COPD)
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NCT05705544Not yet recruitingPeripheral Pulmonary Lesions
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NCT05705531Not yet recruitingCardiovascular Diseases Hodgkin Lymphoma Clonal Hematopoiesis of Indeterminate Potential Therapy-related Clonal Hematopoiesis
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NCT05705492Not yet recruitingAdvanced Malignant Solid Neoplasm
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NCT05705505Not yet recruitingEndometrioid Endometrial Cancer
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NCT05705401Not yet recruiting
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NCT05705440Not yet recruiting
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NCT05705323Not yet recruitingSleep Tinnitus Depression, Anxiety Distress, Emotional
Clinical Research Jobs
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Senior Data Management Lead (Poland, UK, Romania, Hungary, Spain)
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Data Management Lead II (UK, Ireland, Poland, Romania, Spain, Hungary)
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Oncology Solutions Consultant, Director
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(Senior) Regulatory Affairs Consultant - CMC Medical Devices - based EU/UK
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Feasibility and Recruitment Specialist II (Site Feasibility Liaison)
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Sr. Quality & Regulatory Specialist
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IT Support Technician - English & French
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Biomanufacturing Technician-Shift C (Tuesday-Friday/11:30 a.m.-10:00 p.m.)
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Quality Systems Specialist III
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Biomanufacturing Technician-Shift A (Sunday-Wed/7:30 a.m.-6:00 p.m.)