Data handling and record keeping in a GCP trial should ensure which principle?

Data handling and record keeping in a GCP trial should ensure which principle?

• A. Records are accurate, complete, and stored securely with appropriate retention
• B. Records may be discarded after publication
• C. Data can be altered to improve results
• D. Data handling is optional for sponsors

Answer: (A)

Data handling and record keeping in a GCP trial hinges on keeping records that are accurate, complete, and securely stored for the appropriate retention period. This practice supports data integrity, accountability, and the ability to verify results during audits or inspections. Secure storage with access controls protects participant confidentiality and ensures that the information can be reconstructed if needed. Disposing of records after publication would break the chain of evidence and violate retention requirements, making verification impossible. Altering data to improve results is unethical and violates the principle of data integrity; any changes must be properly documented with an audit trail. Data handling is not optional for sponsors and must be implemented as part of the trial’s regulatory compliance.

Data handling and record keeping in a GCP trial hinges on keeping records that are accurate, complete, and securely stored for the appropriate retention period. This practice supports data integrity, accountability, and the ability to verify results during audits or inspections. Secure storage with access controls protects participant confidentiality and ensures that the information can be reconstructed if needed.

Disposing of records after publication would break the chain of evidence and violate retention requirements, making verification impossible. Altering data to improve results is unethical and violates the principle of data integrity; any changes must be properly documented with an audit trail. Data handling is not optional for sponsors and must be implemented as part of the trial’s regulatory compliance.