What is the difference between co-investigator and sub-investigator?
If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.” Co-investigator is a term that pre-dates the ICH GCP’s. It has subsequently been replaced by the term sub-investigator.
What is a PI at a university?
A Principal Investigator or PI is the individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project.
What is the role of a principal investigator in a clinical trial?
A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial at a study site. Compliance with GCP provides assurance that the rights, safety and well-being of trial participants are protected, and that the results of the clinical trials are credible and accurate.
What does a clinical investigator do?
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 …
Who is responsible for GCP compliance?
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.
Who is the main line of communication with investigators?
The monitor(s) in accordance with the sponsor’s requirements should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: Acting as the main line of communication between the sponsor and the investigator.
How often should GCP training be done?
every three years
Who needs GCP training?
All investigators and staff who are involved in the conduct, oversight or management of NIH funded clinical trials are required to complete training in Good Clinical Practice (GCP) and refresh this training every 3 years, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2) .
How long is GCP valid?
What does GCP consist of?
GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies.
What are the GCP regulations and who enforces them?
GCP follows the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
Which of the following are key principles of GCP?
Key Principles of Good Clinical Practice (GCP) Part 1
- Adherence to ethical principles.
- Risk minimization.
- Subject’s rights, safety, and well-being.
- Adequate drug information.
- Scientifically sound protocols.
- IRB/IEC review and approval and protocol adherence.
- Involvement of qualified physician.
What are the 13 Principles of GCP?
- Trial risk vs trial benefit.
- Information on the Medicinal Product.
- Compliance with the study protocol.
- Medical decisions.
- Informed consent.
- Good Manufacturing Practice.
What is protocol in clinical trial?
The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.