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- 4. INVESTIGATOR: ICH E6 (R2) Good clinical practice - ICH GCP
The Investigator is a person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator
- SOP for Site Staff Qualifications, Training Records and Capability
Be qualified by education, training and experience, including in skills, competencies and training requirements articulated in the National Clinical Trials Governance Framework, to assume ultimate responsibility for the proper conduct of the research
- ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
- Clinical Research Site Personnel Qualifications, Training and . . .
CRS staff receive the appropriate trainings for HSP and GCP New staff (added since a protocol’s initiation) receive these trainings during orientation (if not having completed them within the past three years) and are adequately supervised until completion
- Why You Should Be Qualified to Conduct Clinical Trials as per ICH GCP
The investigators and other site staff that are producing data on the study must provide documented evidence of their qualifications by a current CV, training records and other documentation requested by sponsors, ethics committees, or regulatory authorities
- CLINICAL TRIAL SOP 2: Site Staff Qualifications, Training Records and . . .
Core trial staf should receive TransCelerate accredited GCP training Refresher GCP training should also be available to trial staf, at appropriate intervals to ensure that staf maintain awareness of current clinical trial standards and legislation
- ICHs GCP Guideline - ClinicalResearchAssociateCRA. com
ICH’s GCP guideline provides a unified standard for the European Union (EU), Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organisation (WHO)
- ICH GCP - 8. Essential documents for the conduct of a clinical trial . . .
These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements
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