The sponsor is responsible for selecting the investigator(s).

Before entering an agreement with an investigator and an institution to conduct a trial, the sponsor should provide the investigator(s) and the institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the investigator to review the protocol and the information provided.

The sponsor should obtain the investigator's and the institution's agreement:
1.to conduct the trial in compliance with this Regulations and the applicable regulatory requirement(s), and with the protocol agreed to by the sponsor and given approval by the Ethics Committee;
2.to comply with procedures for data recording and reporting;
3.to permit monitoring, auditing and inspection;
4.to retain the essential documents that the investigator and the institution should file within the time period sponsor specified.
The sponsor, the investigator and the institution should sign the protocol, or an alternative document, to confirm this agreement.

A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO.
The ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
The delegation referred to in the preceding paragraph should be made in writing.
Within the scope of the transferred duties and obligations referred to paragraph 1, CRO shall apply mutatis mutandis to the relevant provisions of the sponsor in this Regulations.

The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals.
The IDMC can recommend to the sponsor whether to continue, modify, or stop a trial.
The IDMC should have written operating procedures and maintain written records of all its meetings.

The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.

Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and functions.

The sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator and the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.

When the investigator, the institution or any trial staff fails to comply with the protocol or this Regulations, the sponsor should adopt immediate measures to ensure the compliance.
While the investigator or the institution does not adopt the measures referred to in the preceding paragraph, the sponsor should take action in accordance with Article 116.