How often should GCP training be done?

How often should GCP training be done?

every three years

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.

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 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) .

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.

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 Co-investigator is a term that pre-dates the ICH GCP’s. It has subsequently been replaced by the term sub-investigator.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 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.

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.

How long is GCP valid?

3 years

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.

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.

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?

  • Ethics.
  • Trial risk vs trial benefit.
  • Information on the Medicinal Product.
  • Compliance with the study protocol.
  • Medical decisions.
  • Informed consent.
  • Confidentiality.
  • Good Manufacturing Practice.

How do you retain participants in a study?


  1. Express appreciation of participants’ involvement and efforts (routine)
  2. Ensure confidentiality of Information provided (routine)
  3. Obtain and update contact information (routine)
  4. Allow for the flexible scheduling of appointments (routine)

What are the 3 stages of memory?

Stages of Memory: Sensory, Short-Term, and Long-Term Memory But not all information makes it through all three stages; most of it is forgotten.

What is ICH guideline?

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.

Is GCP a legal requirement?

‚ÄúThose conducting clinical trials of investigational medicinal products (CTIMPs) must comply with the high level conditions and principles of GCP, but there is no legal requirement for other types of research to do so. …

What are the 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 is meant by research protocol?

A research protocol is the guidebook for a research study. It describes what the researchers are intending to do and how they will do it. Writing a protocol ensures that all the major issues are considered in designing and developing a particular research project.

How do you study for retention?

  1. Learn in Multiple Ways. Focus on learning in more than one way.
  2. Teach What You’ve Learned to Another Person.
  3. Utilize Previous Learning to Promote New Learning.
  4. Gain Practical Experience.
  5. Look Up Answers Rather Than Struggle to Remember.
  6. Understand How You Learn Best.
  7. Use Testing to Boost Learning.
  8. Stop Multitasking.

How do you improve retention in a study?

Once they’ve agreed to be part of a study, your very next task should be working to retain them….5 Ways to Increase Retention of Your Trial Participants

  1. Show appreciation for participants.
  2. Develop relationships.
  3. Increase communication.
  4. Create a community.
  5. When participants leave, find out why.