Good Clinical Practice in Human Research

 

Background

 

What is Good Clinical Practice?

Good Clinical Practice (GCP) is a unified international ethical and scientific standard for conducting biomedical and behavioral research involving human participants. Prior to GCP standards, numerous instances of serious incidents in research, and the exposure of these incidents, spurred the development of regulations and ethical guidelines to protect human research participants from harm and abuse.

 

What are the Good Clinical Practice guidelines?

The Good Clinical Practice (GCP) guidelines were prepared in association with the International Council for Harmonization (ICH) in order to provide a framework for the safe, fair, and scientifically sound conduct of all research involving human participants. This includes clinical investigations for a marketed drug, investigational product, medical device, or behavioral intervention. The guidelines ensure that data and results collected in clinical trials are credible and accurate, and that the safety, rights and confidentiality of participants are protected.

Specifically, these are the principles put forward by ICH GCP (National Drug Abuse Treatment Clinical Trials Network):

  1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
  2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial participant and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
  3. The rights, safety, and well-being of trial participants are the most important considerations and should prevail over the interests of science and society.
  4. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
  5. Clinical trials should be scientifically sound and described in a clear, detailed protocol.
  6. A trial should be conducted in compliance with a protocol that has received prior institutional review board (IRB) approval.
  7. The medical care given to, and medical decisions made on behalf of, participants should always be the responsibility of a qualified physician or, when appropriate, a qualified dentist.
  8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
  9. Freely given informed consent should be obtained from every participant prior to clinical trial participation.
  10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
  11. The confidentiality of records that could identify participants should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
  12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
  13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.

 

Why is GCP training necessary and who needs to complete it?

GCP training ensures that there is a shared understanding of the basic principles of research and is crucial for all personnel (e.g., principal investigators, students) conducting research on behalf of Reichman University and who are directly involved in the collection of data in at least one of these two settings:

  1. Clinical trial: A clinical trial (or interventional study) is defined here as a research study in which researchers assign participants to get one or more interventions and test their clinical effects. The interventions can be pharmaceutical, behavioral, device-based, or any other type of method that can affect the clinical status of the participant and which could potentially serve to improve people’s health and care.                                                This does not apply to observational studies. Observational studies involve research in which data are collected but no intervention group assignment takes place; or if there is an intervention, participants were already using it as part of their regular health care or daily life; or studies in which data were already collected.
  2. An investigator on a request for Helsinki committee approval: All individuals appearing as investigators (principal or otherwise) on a request submitted to a Helsinki committee for approval of a research study (e.g., an MRI study).

 

GCP training is not specific to any one protocol and is valid for 3 years. Research staff who are involved in a relevant study but do not collect data are encouraged to complete GCP training but are not required to do so.

 

How to obtain GCP certification

 

In order to obtain GCP certification, you must complete and pass a course. The course will cover topics such as research misconduct, informed consent, participant safety and adverse events, documentation and record-keeping, quality assurance and more.

The National Institutes of Health (NIH) in the US offers a free-of-charge, online course at https://gcp.nidatraining.org/. It takes approximately six hours to complete, and is self-paced.

 

In order to take the course and acquire the certification, please follow these instructions:

  1. Go to: https://gcp.nidatraining.org/register.
  2. Create an account by filling out the required information: 

1.First Name: Ensure your full legal name is used as it will be necessary for your certificate
2.Last Name
3.Study Role/Title: PI, student, etc
4.Organization: Reichman University
5.Location: Israel
6.NIH-Affiliated: No
7.My IRB requires a 100% passing grade: No
8.Email: Use your Reichman University email address to register
9.Password
10.Confirm Password

  1. Complete the course. To obtain a certificate you must successfully complete a quiz for each module of the course with a score of minimum 80%. Once you have successfully completed the course, you will have access to view or print the Certificate of Completion under the Certification page. Please keep the certificate.

 

If you have any questions, please contact Dr. Rany Abend (rany.abend@runi.ac.il).