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GOOD HOSPITAL PRACTICE

GOOD HOSPITAL PRACTICE

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QM according to DIN EN 15224 / ISO 9001

5.2.04 Clinical-experimental research programme

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Goal and purpose

If a new product (treatment method) is developed by the organisation or if it is involved in a new development, an appropriate research programme is drawn up. The clinical studies should be conducted in accordance with the applicable rules of clinical research. A research department is commissioned to conduct the study in accordance with the rules of "Good Clinical Practice (GCP)" (see also VA 3.2.4 and 5.2.6).

Application

Description of the process

Risks

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Material

Time required

Documentation

Responsibility and qualification

Notes and comments

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5.2.04 Clinical-experimental research programme

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