The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.

Data reported on the CRF should be consistent with the source documents. The discrepancies should be explained.

Any change or correction to a CRF should be dated, initialed, and explained and should not obscure the original entry.
The preceding regulation applies to both written and electronic changes or corrections.
The investigator should designate a person to document changes or corrections in CRF. All changes or corrections should be endorsed by the investigator.
The investigator should retain records of the changes and corrections.

The investigator and the institution should pay sufficient attention to properly maintain all the important trial documents, and take measures to prevent accidental or premature destruction of these documents.
The documents referred to in the preceding paragraph shall be retained until 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.

The financial aspects of the trial should be documented in an agreement between the sponsor and the institution or the investigator.

The monitor, auditor, the Ethics Committee, or the Competent Authority, can request for direct access to all trial-related records. However, prior to access to the subject’s personal identity information, confirmation of the subject’s written consent is required.

The Competent Authority may request the investigator to submit written reports to the institution, elaborating the trial status.
The investigator and the institution should submit written summaries of the trial status to the Ethics Committee annually. If necessary, the Ethics Committee may request to shorten the interval of the routine reports.

The investigator shall promptly provide written reports to the sponsor, the Ethics Committee and the Competent Authority on any situation significantly affecting the conduct of the trial, and/or increasing the risk to subjects.

The investigator shall immediately report any serious adverse events to the sponsor, and shall provide detailed, written reports as soon as possible. The investigator shall immediately report any suspected unexpected serious adverse drug reactions to the Ethics Committee. However, those SAEs that the protocol or other document identifies as not needing immediate reporting shall not apply.
The sponsor shall report any suspected unexpected serious adverse reactions that are fatal or life-threatening to the Competent Authority or the contracted organization within 7 days after being aware of the event, and shall provide detailed written documents within 15 days after being aware of the event.
The sponsor shall report all the other suspected unexpected serious adverse reactions to the Competent Authority or the contracted organization and provide detailed written documents within 15 days after being aware of the event.
The subjects’ identity should be coded in the oral and written reports mentioned in paragraph 1 that should not reveal subjects’ names, ID numbers, addresses, or any other information which may reveal subject’s personal identity.
The serious adverse events and serious adverse drug reactions are defined and announced by the Competent Authority.

When adverse events or laboratory abnormalities are identified as critical to safety evaluations, the investigator should report to the sponsor within the time periods specified by the sponsor in the protocol.

For reported deaths, the sponsor, the Ethics Committee, and the Competent Authority may request the investigator to provide autopsy reports, terminal medical reports and any additional information.

The sponsor shall promptly notify all investigator(s), institution(s) and the Competent Authority for any of the following situations:
1.New findings that could affect adversely the safety of subjects.
2.New findings that impact the conduct of the trial.
3.New findings that alter the Ethics Committee's approval to continue the trial.

The sponsor shall submit the latest safety reports to the Competent Authority.

Upon the trial is completed or prematurely terminated, the investigator and the institution shall provide the sponsor and the Competent Authority with any reports required, and provide the Ethics Committee with a summary of the trial’s outcome.
Under the circumstances referred to in the preceding paragraph, the sponsor shall provide the Competent Authority with a complete and detailed clinical trial report.
The format of the clinical trial reports referred to in the preceding paragraph is announced by the Competent Authority.