Frequently Asked Questions

ClinicalResearch.com is a website that aims to increase clinical research awareness, understanding, and participation. You can use the website to express an interest in becoming a clinical trial investigator (coming soon). You can also learn more about the clinical drug development process and what patients may experience while taking part in a clinical trial in The Patient Journey. In addition, you can register to receive updates on conditions of interest to you, including notifications when new clinical trials start recruiting patients.

Clinical trial investigators are usually physicians in active practice. They are responsible for the day-to-day management of clinical trials at the site level. Their main responsibilities are ensuring patient safety during the trial and safeguarding patients’ rights, making sure that trial activities and procedures are done in accordance with the protocol. Clinical trial investigators are also responsible for maintaining the quality of data collected during the trial.

By conducting clinical trials, physicians can be at the cutting edge of research in their medical field. This may add prestige to their medical practice and respect within the professional community. Being a clinical trial investigator also helps you to connect patients to clinical trials that are right for them.

IQVIA is committed to delivering excellency in clinical trials and adhering to the highest standards of scientific research. With over 30 years of experience in running and optimizing clinical trials, IQVIA has the people, processes, and technology to streamline the investigator experience – from communication to training to workflow for the entire course of a trial.

If you are interested in becoming a clinical trial investigator, you can start by registering in our database (coming soon). Our staff will assess the information provided and contact you when a future clinical trial matches your interest.

Each potential participant in a clinical trial is helped to make an informed decision about their participation, and informed consent is at the heart of this process. The overall purpose of the informed consent process is to offer potential participants detailed information about the trial aim, the tested intervention, potential benefits and risks, specific procedures, and participants’ rights and responsibilities.

Once the potential participant decides to join a trial, they must sign the Informed Consent Form (ICF). Participants have the right to withdraw from the trial at any time without any explanation and without jeopardizing their standard of medical care.

The institutional review board (IRB)/ethics committee (EC) is a local administrative body that safeguards the rights and safety of participants involved in a clinical trial. It reviews trial documentation (e.g. the Clinical Trial Protocol, Participant Information Sheet, and Informed Consent Form) and provides an opinion on the proposed research. The outcome of the review may vary, and the trial can be approved, approved with comments, or rejected.

The IRB/EC members have various backgrounds (e.g. physicians, nurses, statisticians, and community representatives). It operates in accordance with national and/or local regulations and the
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice guidelines.

The IRB/EC is also entitled to perform periodic checks throughout the trial duration.

The Good Clinical Practice (GCP) guidelines are the principles and practices that are followed to ensure participant safety and well-being. Compliance with GCP helps ensure that the rights, safety, and well-being of trial participants are protected, and that research data are reliable. 

If you want to be involved in clinical trials, you should have a good understanding of GCP, which is the international ethical and scientific quality practical standard to which all clinical research should adhere. 

Clinical trials must be conducted in compliance with the international and national regulations governing the conduct of trials derived from the Declaration of Helsinki, US Food and Drug Administration (FDA) regulations, or European Medicines Agency (EMA) directives.

To facilitate development and implementation of clinical trials, a research infrastructure may be available to you. It consists of specialized units that offer support for trial set-up, conduct, monitoring, networking, and training. These units are organized at the national, central, or local level and can include clinical research offices, research and development departments, clinical trials units, and investigator networks.

References

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