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GOOD HOSPITAL PRACTICE

GOOD HOSPITAL PRACTICE

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The QM manual for the entire hospital

5.2.07 Risk assessment for clinical studies

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Goal and purpose

A process-related matrix of risks and risk assessments (risk indicators) with corresponding measures to reduce risks is created for all phases of a research project. The acceptability of residual risks is assessed. The acceptability of the residual risks is assessed. For the method, see 5.4.05

Application

Description of the process

Risks

Resources

Material

Time required

Documentation

Responsibility and qualification

Notes and comments

Applicable documents

Validation documents

Terms

Attachments

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