Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, and reporting clinical trials involving human subjects.
1.Informed Consent
Participants must voluntarily sign informed consent forms after being fully informed about the trial’s nature, risks, and benefits.
2.Ethics Committee Approval
Every clinical trial must be reviewed and approved by an Institutional Ethics Committee to protect participant rights and safety.
3.Data Integrity
All trial data should be complete, accurate, and documented properly to ensure reliability of results.
4.Subject Safety
Ensure regular safety monitoring, report adverse events promptly, and prioritize patient well-being above all.
5.Qualified Investigators
All investigators should be medically qualified and trained in GCP to responsibly conduct the trial.
6.Protocol Compliance
All activities must align with the approved clinical trial protocol. Any deviations require documentation and approval.
7.Maintain Confidentiality
Keep subject identities and health records confidential. Use secure systems for data management.
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