Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.

The sponsor should utilize appropriately qualified individuals to be responsible for the following work:
1.to supervise the overall conduct of the trial,
2.to handle the data and to verify the data,
3.to conduct the statistical analyses, and to prepare the trial reports.
4.to perform operations related to conducting the trial.

When using electronic trial data handling or remote electronic trial data systems, the sponsor should:
1. Based on the risk assessment, ensure that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation).
2.Follow and maintain SOPs for using these systems.
3.Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data; the system shall maintain an audit trail, data trail, edit trail separately.
4.Maintain a security system that prevents unauthorized access to the system or data.
5.Maintain a list of the individuals who are authorized to make data changes.
6.Maintain adequate backup of the data.
7.Safeguard the blinding.
8.Ensure the data integrity in the case of any change in the computer system.

If data are transformed during processing, it should always be possible to compare the original data and observations with the processed data.

The sponsor should use an unambiguous subject identification code that allows identification of all the data reported for each subject.

The sponsor, or other owners of the data, shall retain all of the sponsor-specific essential documents pertaining to the trial for at least 2 years after approval of the marketing application of the investigational product(s) in Taiwan. However, these documents shall be retained for a longer period if required by other applicable regulatory requirements.

If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the trial investigators, institutions and the Competent Authority.
Under the preceding circumstance, the sponsor shall maintain all sponsor-specific essential documents for at least 2 years after formal discontinuation. However, these documents shall be retained for a longer period if required by other applicable regulatory requirements.

Any transfer of ownership of the data shall be reported to the Competent Authority.

The sponsor should inform the investigator(s) and the institution(s) in writing of the need for record retention. When the trial related records are no longer needed, the sponsor should notify the investigator(s) and the institution(s) in writing.