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Quality control activity are vital to ensuring the quality of the clinical trial. Our CRAs use a specific checklist in reviewing the data collected from the medical institutions to ensure that the data follow the protocol and the procedures.
- Adjust clinical trial standard business procedure sheets (*2) with the pharmaceutical company to make sure they meet the proper standards
- Confirm quality control policies
- Confirm the quality control system
- Check all documents
- Check the clinical case reports
*2: A clinical trial standard business procedure sheet is a procedure sheet that gives a systematic overview of basic business procedures for medical drug development, in order to make sure the clinical trial is conducted in an ethical and scientifically appropriate manner, as well as to assure the reliability of the test results. It is created based on the GCP.
