What is a clinical white paper?

What is a clinical white paper?

A white paper is an authoritative document intended to fully inform the reader on a particular topic. It combines expert knowledge and research into a document that argues for a specific solution or recommendation. The white paper allows the reader to understand an issue, solve a problem, or make a decision.

What qualifies as clinical research?

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

What is a source document in clinical research?

Source documents are original documents created during a clinical study, from which study data are obtained. The purpose of source documents is to document the existence of study participants and substantiate the integrity of the study data collected.

Why is GCP important to clinical research?

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 GCP quality?

Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.

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 is GCP training?

GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. GCP training aims to ensure that: the rights, safety, and well-being of human subjects are protected. clinical trials are conducted in accordance with approved plans with rigor and integrity.

How long does it take to complete GCP training?

As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around three to six hours to complete a GCP course.

How long are GCP certification valid?

GCP training must be renewed every 3 years through one of the following: Completing the CITI GCP “refresher module” that is available for those who have completed the initial CITI GCP training.

How long is Transcelerate GCP training valid for?

Generally speaking, Site Investigators complete GCP training within three (3) years of the start of a new study. Investigators are not expected to retake GCP training during the study (unless required by local regulation or at the discretion of the sponsor).

Why is GCP training important?

Introduction. GCP is an international standard for clinical trials that ensures that the rights, safety, and well-being of clinical trial subjects are protected and that the clinical trial data are credible. Various legislative requirements exist for GCP training from a country level to global.

Is GCP training required by the FDA?

Yes, the Food and Drug Administration (FDA) conducts GCP training. It provides FDA’s perspectives on new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research, and acceptable scientific and analytic standards in clinical study design and conduct.

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.