What is the difference between chief investigator and principal investigator?
This may be the chief investigator, or where the research involves more than one site, the principal investigator is the person at each site responsible for the day to day running of the research project.
Which of the following are the responsibilities of the principal investigator PI of a study?
The Principal Investigator (PI) is an individual who assumes full responsibility for a research study, including but not limited to, the oversight and training of research assistants, administration of informed consent, and protecting participant confidentiality.
Can nurse practitioners be principal investigators?
Nurse practitioners (NPs) are ideally suited to assume roles of principal investigators (PIs) in clinical trials. NPs are trained and authorized to perform physical examinations, make clinical assessments, diagnose and treat diseases, and prescribe drugs, either independently or in collaboration with a physician.
Can a physician assistant be a principal investigator?
usually Principal Investigators are required to be licensed physicians when it comes to participating in clinical trials. Non physicians such as chiropractors, registered nurses, physician assistants are typically relegated to sub investigator positions. There are however, always exceptions to the rules.
What is pi oversight?
According to the regulations for clinical trials, the PI is personally responsible for conducting and. supervising the conduct of human subjects research by “protecting the rights, safety, and welfare of subject’s under the investigator’s care”.
What is a co pi?
Co-Principal Investigator (Co-PI) A Co-PI is a senior member of the key personnel team whose role is similar to that of the PI in determining the intellectual content, direction, and conduct of the research or program activities.
What is a PI in clinical trials?
The person(s) in charge of a clinical trial or a scientific research grant. The PI prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant. The PI also analyzes the data and reports the results of the trial or grant research.
Why is oversight important in clinical trials?
Clinical trial oversight is a critical element that ensures the protection of research participants and integrity of the data collected. The trial sponsor, a local IRB and independent monitoring committees all contribute with complementary but overlapping responsibilities.
Which of the following are GCP responsibilities of the investigator?
What is GCP?
- Ensures that the rights, safety, and well-being of study participants are protected.
- Ensures the integrity of the data submitted for approval.
- Sets standards for a system of mutual accountability among sponsors, regulatory authorities, investigators, and IRBs.
What is an important component of drug accountability?
Drug accountability includes: study drug storage, handling, dispensing, and documentation of administration, return and/or destruction of the drug. An accurate investigational drug accounting process begins with the sponsor’s shipping manifest.
What are good clinical practice guidelines?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.
What are clinical practices?
The Institute of Medicine (IOM) defines clinical practice guidelines as “statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options” [1].
What are the ICH guidelines?
ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities.
What is clinical protocol?
Clinical protocols are basically rules of how to proceed in certain situations. They provide health care practitioners with parameters in which to operate. The term ‘code of practice’ may be used synonymously with clinical protocols. A code comprises a set of laws or rules.
What is protocol give example?
A protocol is a standard set of rules that allow electronic devices to communicate with each other. Protocols exist for several different applications. Examples include wired networking (e.g., Ethernet), wireless networking (e.g., 802.11ac), and Internet communication (e.g., IP).
What is the main goal of clinical protocols?
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.
What are different types of protocol?
Types of Protocols
- Transmission Control Protocol (TCP)
- Internet Protocol (IP)
- User Datagram Protocol (UDP)
- Post office Protocol (POP)
- Simple mail transport Protocol (SMTP)
- File Transfer Protocol (FTP)
- Hyper Text Transfer Protocol (HTTP)
- Hyper Text Transfer Protocol Secure (HTTPS)
What are the uses of protocol?
Communication protocols allow different network devices to communicate with each other. They are used in both analog and digital communications and can be used for important processes, ranging from transferring files between devices to accessing the internet.