Table of Contents
What are the responsibilities of a clinical investigator?
A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator’s care; and for the …
What is the sponsor’s responsibility?
Generally, a sponsor is responsible for: Selecting the investigator(s) Providing investigator(s) with the necessary information to conduct the clinical trial. Ensuring proper monitoring of the clinical study.
What are the 3 main types of ICH guidance documents?
Multidisciplinary Guidelines It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Who is the main line of communication with investigators?
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.
What is ICH compliance?
This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.
What is the primary purpose of the ICH?
A primary purpose of the ICH is to: Minimize the need for redundant research. The ICH GCP Guidelines: Set standards for the design, conduct, monitoring and reporting of clinical research.
What is the ICH GCP guidelines?
The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
What is the purpose of ICH GCP?
What is the purpose of ICH?
The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.