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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Insurance and Liability
  1. Are protocol violators still covered by the indemnity declaration provided by the sponsor?
    It will depend on the extent of the indemnity provided and the circumstances of the violation. However, this is a legal issue rather than GCP.

 

 
 

Opinion Poll

Which of the following general ethical issues to conduct clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

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