Are monitors responsibilities specified in ICH GCP?

Are monitors responsibilities specified in ICH GCP?

(a) Monitors should be appointed by the sponsor. (c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).

What is monitoring in ICH GCP?

Definition: ICH- GCP defines monitoring as the act of overseeing the conduct of a clinical trial, that is, ensuring that the trial is conducted according to protocol, GCP, SOP and regulatory requirements. It is the responsibility of the sponsor to ensure the trial is adequately monitored.

What is the role of the monitor in clinical trials?

the Clinical Monitor, acting as the main line of communication between the sponsor and the investigator, is able to provide assistance to investigators ensuring that the trial is conducted and documented properly.

Who is responsible to comply with and ensure compliance with ICH GCP?

The PI
Compliance with the Protocol (ICH GCP 4.5) The PI is responsible for ensuring that the study is conducted in compliance with the research protocol. He or she should ensure that all protocol violations are identified, documented, and reported in accordance with sponsor and IRB requirements.

What do you need to know about ICH’s GCP?

Clinical Trial Monitoring Under ICH’s GCP. ICH’s GCP describes the need for clinical trial monitoring as one of the important responsibilities of the sponsor. ICH’s GCP requires that clinical trial monitoring are conducted to ensure that: The rights and well-being of human subjects are protected. The reported data are accurate, complete

What are the responsibilities of an Ich investigator?

Investigator’s Responsibilities is an important section of the ICH’s GCP. As part of investigator’s qualification, I usually go over this section with the site investigator to ensure that they understand their role and responsibilities. Below are some of the responsibilities for an investigator:

Who is responsible for Supervision in ICH E6?

4.2.5 The investigator is responsible for supervising any individual or party to whom the investigator delegates study tasks conducted at the trial site. 4.2.6 If the investigator/institution retains the services of any party to perform study tasks they should ensure this party is qualified

When to appoint a monitor for a GCP trial?

(c) The conduct of the trial is in compliance with the currently approved protocol/amendment (s), with GCP, and with the applicable regulatory requirement (s). 5.18.2 Selection and Qualifications of Monitors (a) Monitors should be appointed by the sponsor.