E6: Investigator's Qualifications and Agreements Flashcards
Investigator’s Qualifications and Agreements
4.1.1
The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).
Investigator’s Qualifications and Agreements
4.1.2
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.
Investigator’s Qualifications and Agreements
4.1.3
The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
Investigator’s Qualifications and Agreements
4.1.4
The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
Investigator’s Qualifications and Agreements
4.1.5
The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
4.2 - Adequate resources
4.2.1
The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.
Adequate resources
4.2.2
The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
Adequate resources
4.2.3
The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.
Adequate resources
4.2.4
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.
Adequate resources
4.2.5
The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.
Adequate resources
4.2.6
If the investigator/institution retains the services of any individual or party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.
