The investigator(s) shall meet all the qualifications and abilities specified by the Competent Authority, and shall have experiences and resources for the proper conduct of the trial.

The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.

The investigator shall be aware of, and shall comply with, this Regulations and the applicable regulatory requirements.

The investigator and the institution shall permit monitoring and auditing by the sponsor, and inspection by the Competent Authority or the delegated agencies.

The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

The investigator should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period.

The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.

The investigator should have available an adequate number of qualified staff and adequate facilities to conduct the trial properly and safely.
The investigator shall supervise the individual and party delegated by him/her to perform duties related to the trial.

The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

If the protocol and Investigator's Brochure are updated during the trial, the investigator and the institution shall supply a copy of the updated ones to the Ethics Committee.