Regulatory overview. Submit a CRM notification. Good Clinical Practice Inspections. Report adverse events. Innovation Office. Conducting clinical trials. Participating in clinical trials. Clinical Trials Register. Understand the processes for preparation, conduct and follow up of Good Clinical Practice Inspections. A Good Clinical Practice GCP Inspection is an official review of documents, facilities, records and any other resources that are related to your clinical trial.
The inspection may be done at the site of the trial, the sponsor's or contract research organisation's facilities or at another appropriate location. The inspection may also take place at multiple sites where required.
The inspectee of a GCP Inspection may either be the Principal Investigator or the sponsor of the clinical trial being inspected. GCP inspections may either be protocol-specific or systems. The objectives of both types of inspections are to:. GCP Inspection Findings will be graded based on the impact on the goals of GCP, frequency of occurrence, and corrective and preventive actions that can be taken. Looking Back at KB. Regulatory overview. Submit a CRM notification. Report adverse events.
Innovation Office. Conducting clinical trials. Participating in clinical trials. Guidance documents. Clinical Trials Register. Clinical trials statistics.
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