The investigator and the institution should conduct the trial in compliance with the protocol agreed to by the sponsor, by the Ethics Committee and by the Competent Authority. The investigator, the institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.

The investigator should not implement any deviation, or changes of the protocol without agreement by the sponsor and prior approval from the Ethics Committee, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only administrative aspects of the trial.
For a deviation, or a change of, the protocol implemented to eliminate an immediate hazard(s) to trial subjects, the investigator should submit the implemented deviation or change, the reasons for it, or the proposed protocol amendment(s) to the Ethics Committee and the sponsor, and to the Competent Authority if the trials are approved by the Competent Authority.

The investigator, or person designated by the investigator, should document and explain any deviation from the protocol.

The investigator or the institution should be responsible for the accountability and storage of the investigational product(s).
The investigator or the institution may assign some or all of the duties for investigational product(s) accountability and storage at the trial site(s) to designated pharmacists or other appropriate individuals.

The investigator, the institution and the designated pharmacist or other appropriate individual should maintain following records:
1.Records of the product's delivery to the trial site;
2.The inventory at the site;
3.The use of the investigational product(s) by subjects;
4.The return to the sponsor or alternative disposition of unused investigational product(s).
The preceding records should include dates, quantities, batch/serial numbers, expiration dates, and the unique code numbers assigned to the investigational product(s) and trial subjects.
The investigator should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.

The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).

The investigational product(s) should be used only in the approved protocol.

The investigator, or a person designated by the investigator, should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly.

The investigator should follow the trial's randomization procedures.
Under the preceding randomization procedures, the code should be broken only in accordance with the protocol.
If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding of the investigational product(s).

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.

If the trial is suspended or terminated, the investigator and the institution shall promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects.
Under the circumstances referred to in the preceding paragraph, the investigator and the institution shall inform the Competent Authority of the reasons for suspension or termination of the trial in writing.

If the investigator suspended or terminated a trial without prior agreement of the sponsor, the investigator and the institution shall promptly inform the sponsor and the Ethics Committee, and provide detailed written reports.

If the sponsor suspended or terminated a trial, the sponsor shall promptly inform the investigators, the institutions, the Ethics Committee, and the Competent Authority and the reason(s) for the termination or suspension, and provide detailed written reports.

If the Ethics Committee terminated or suspended a trial, the investigator and the institution shall promptly inform the sponsor, and provide the detailed written reports.

If the investigator or the institution seriously or repeatedly violates the protocol, the sponsor should stop the investigator or the institution from conducting the trial and promptly notify the Competent Authority.

When conducting a multicenter trial, all investigators should conduct the trial in compliance with the protocol agreed to by the sponsor and approved by the Competent Authority, and by the Ethics Committee.

When conducting a multicenter trial, for those investigators who are collecting additional data according to the protocol, the sponsor should provide supplemental CRFs that are designed to capture the additional data.

The coordination approaches and responsibilities of the investigator(s) and the other participating investigators should be documented in writing prior to the start of a multicenter trial.

When conducting a multicenter trial, all investigators should comply with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs.

When conducting a multicenter trial, the sponsor should facilitate communication between all investigators.