Good Clinical Practices (GCP)

Good Clinical Practices or GCP are guidelines that cover the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of clinical studies.

Clinical trials are sensitive research processes that can, if handled wrongly, create legal liabilities and ethical issues for organizations. Therefore, companies that need to research the effect and efficacy of newly developed pharmaceuticals or medical treatment on human subjects need to be aware of and compliant with Good Clinical Practices or GCP.

GCP ensures that:

  • The rights, safety and wellbeing of trial subjects are protected;
  • The clinical trial data are credible.

Each country has its own set of guidelines for Good Clinical Practices. The International Conference on Harmonization or ICH, which aims at creating a universal set of guidelines for the pharmaceutical industry, has created its own guideline for GCP. This guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

To understand how Good Clinical Practices ensure the safety and efficacy of clinical trials,


Clinical Trial Sponsor

A clinical trial sponsor is the individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

According to GCP guidelines, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and regulatory requirements.

To learn the roles and responsibilities of a sponsor in a clinical trial, read more>>

Clinical Trial Investigators

A clinical trial investigator is the person responsible for the conduct of the clinical trial at a trial site. If the clinical trial is conducted by team of individuals at the trial site, then the investigator is the responsible leader of the team and is known as the Principal Investigator.

To understand the role of clinical trial investigators, read more >>

Clinical Trial Monitoring

Clinical trial monitoring is an integral part of Good Clinical Practices. The purposes of clinical trial monitoring are to verify that:

  1. The rights and well-being of human subjects are protected.
  2. The reported trial data are accurate, complete, and verifiable from source documents.
  3. The conduct of the trial is in compliance with the protocol, GCP, and regulatory requirements

To get a better understanding of the process of clinical trial monitoring, read more>>

Clinical Trial Audits

A sponsor’s audit of a clinical trial is an important element of GCP and is independent of and separate from monitoring and quality control functions. Its purpose is to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

The auditor chosen by the sponsor to audit a clinical trial should be:

  • Independent of the clinical trials/system
  • Qualified by training and experience to conduct the audits properly and these qualifications should be documented

Read more about sponsor audits of clinical trials >>

Institutional Review Boards (IRBs), Independent Ethics Committees (IEC)

An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is an independent body comprising medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial.

An IRB/IEC should carry out the following activities to guarantee the rights and safety of trial subjects:

  • Review and approval of trial protocols and amendments
  • The review and approval of methods and materials used to obtain and document informed consent of trial subjects

Read more about Institutional Review Boards (IRBs) or Independent Ethics Committees (IEC)>>

Informed Consent in Clinical Trials

Informed consent is a cornerstone and key ethical consideration in clinical trials. It is a critical component of any GCP guideline. Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. Informed consent is not a one time event - it a continuing process throughout the study, providing information for participants.

To get a better understanding of the process and GCP compliance, read more >>

Clinical Trial Documentation

Proper clinical trial documentation is important in ensuring GCP compliance. Documentation is defined by GCP guidelines as all records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Essential documents in a clinical trial are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.

Clinical Trial Protocols

A clinical trial protocol is an essential element in GCP guidelines and compliance. At its most basic, a clinical trial protocol is a study plan on which all clinical trials are based.

A protocol or plan has to be properly designed in order to protect the welfare and health of trial subjects as well as properly answer clinical research questions.

Learn more about the Clinical Trial Protocols requirements >>

Clinical Trial Investigator’s Brochure

The Investigator's Brochure or IB is a compilation of the clinical and nonclinical data on the investigational product that is relevant to the study of the product in human subjects.

GCP guidelines state that the purpose of the IB is to provide the investigators and others involved in the trial with the information to improve their understanding and compliance with of the protocol.

To learn about the essential information to be included in an investigator’s brochure, read more >>

Clinical Trial Safety Reporting

Clinical trial safety reporting is an integral part of the clinical study process. GCP guidelines give clear requirements regarding the reporting of serious adverse events (SAEs) and abnormalities.

An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

To get a better understanding of clinical trial safety reporting requirements, read more>>

ComplianceOnline training on clinical trials

Clinical Trials and Good Clinical Practice
This Clinical Trials and GCP session describes the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.

The Importance of ICH Guidelines and its Role in Achieving Good Clinical Practice
This presentation reviews the key concepts of GCP and correlates them to the ICH guidelines.

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits
This Clinical Trial training provides a detailed review of the FDA regulations for Clinical Trials Process.

The ICF Process: Tips on Achieving Optimal compliance and Comprehension.
This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being.

Are your Informed Consents in compliance with new FDA Regulations - An update on the informed consent process.
This webinar discusses the steps to prepare an informed consent document under different situations.

Full Day Virtual Seminar: Clinical Research GCP training Course
This full day GCP training course provides comprehensive learning on the Good Clinical Practices of Research involving human subjects. It covers all key areas including recruiting study subjects, the Informed Consent process, Adverse Event Reporting and preventing protocol deviations.

Clinical Trials Process: Study Sponsor’s and Investigator’s Responsibilities
FDA Regulations and Good Clinical Practice Guidelines will be discussed with an emphasis on data integrity and the protection of study subject’s welfare/rights.

Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team
This training on a compliant clinical research team focuses on how Clinical Research Coordinators should work in a research team to ensure success of the clinical trial at your site.

CROs (Clinical Research Organizations) – Identification, Selection, and Management for Maximum Results & Value
This CRO training provides all the specific methodology and management techniques to successfully outsource pharmaceutical programs completed on time, within budget, most importantly completed with high level of quality and performance.

Preparing for FDA GCP Inspections – Essentials for Sponsor Companies
This webinar on FDA GCP inspections provides practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

Utilizing ICH Guidelines for GCP Regulatory Compliance
This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections.

Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements
The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6.

Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
This Clinical trial auditing training provides an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.

Responsibilities of a Principal Investigator in Clinical Trials: What you Must Do to Ensure Trial Compliance
Webinar discusses role and responsibilities of clinical trial investigator and the legal and regulatory requirements to follow for Good Clinical Practices (GCP)

Principal Investigator responsibility in Research Involving Human Subjects: The International Conference on Harmonization (ICH) view
This webinar provides invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.

Investigator responsibility/Legal commitment in drug and device clinical research: the reality
To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly.

Why investigators often lose money in conducting sponsored clinical trials
Webinar presents a proven process for investigators to address common deficiencies with respect to costs associated with clinical investigator site requirements for study conduct.

GCP and FDA Regulations with regard to Investigator Responsibility - How to get your PI more involved in the clinical Research process
This CGP compliance Webinar discusses the investigator role and responsibilities in clinical research process and highlights the ways to involve effectively the Principal Investigator in clinical research process.

GCP violations and Site Mistakes commonly found During a FDA Investigator Site Inspection/Audit and how to avoid them
This GCP training guides you through key component identification of a good GCP audit program, Investigator awareness, Protocol adherence, The Informed Consent process, Evaluation of subject selection, Inclusion/exclusion criteria, data sampling and audit findings assessments.