What is the definition of sponsor as per ICH GCP?
1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
What is a sponsor of a clinical trial?
A person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.
What is a sponsor required to do when using electronic trial data handling and or remote electronic trial data systems?
3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should: (a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e..
What is a sponsor in a study?
All research requires a sponsor. The sponsor is the individual, company, institution or organisation that takes on legal responsibility for the initiation, management and/or financing of the research.
What is IB in clinical trials?
The Investigator’s Brochure (IB) is a comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device or other product) maintained by a drug developer or investigator that contains the body of information about the investigational product obtained before and during a …
What are the responsibilities of the sponsor?
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 is the responsibility of a sponsor?
Responsibilities as a Sponsor If an immigrant you sponsored receives any means-tested public benefits, you are responsible for repaying the cost of those benefits to the agency that provided them. If you do not repay the debt, the agency or the immigrant can sue you in court to get the money owed.
What is the responsibility of the sponsor?
What is the difference between funding and sponsorship?
is that sponsor is a person or organisation with some sort of responsibility for another person or organisation, especially where the responsibility has a religious, legal, or financial aspect while fund is a sum or source of money.
What is a clinical trial ICH GCP?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
What is ICH Guideline for clinical trial?
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.