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Clinical Research Regulations > ICH GCP Rev3 (not for exam) > Flashcards

ICH GCP Rev3 (not for exam) Flashcards

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Clinical Research Regulations (31 decks)

The Nuremberg Code - C

The Belmont Report - C

The Declaration of Helsinki - C

ICH GCP Rev3 (not for exam)

Coordinate the development of initial research study protocol

Create or obtain research study documents

Obtain research study approval from necessary stakeholders

Obtain research study product, related materials, equipment, tools and aids

Select research study sites

Train research study staff members

Evaluate research study's compliance with relevant local, state and provincial laws

Execute Research Strategy

Assure regulatory compliance

Manage research study product

Identify, document & report research study anomalies

Manage subjects Recruit subjects

Maintain the research study

Communicate with research study stakeholders

Perform/participate in a research study audit

Perform/participate in a research study closeout visit

Develop & submit research study closure reports

Archive/retrieve research study records

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