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OVERVIEW

The Good Clinical Practice course is aimed at training clinical research staff on the execution of clinical trials involving human participants

In detail, the modules that make up the course are fashioned to align with the principles of ICH GCP and the Code of Federal Regulation, affecting clinical research trials.

Good Clinical Practice establishes a framework of principles that must be followed to ensure the protection of the subjects participating in clinical trials and the quality, integrity, and validity of the data produced. This training aims to offer basic principles of GCP and explain how these principles can be used in practice within the research environment. Target Audience The training course shall be addressed to all those engaged in clinical research.

Program Deliverables

The accompanying training is appropriately aligned with the current Industry's expectations.

Interactive online live sessions by experienced faculties

The modules shall include the course based on ICH GCP Principles and the Code of Federal Regulations (CFR) on clinical research trials

All learning and training delivery initiatives shall be in English

ABOUT US

GCP standards are the international ethical, scientific, and practical by which all clinical research is conducted. Good Clinical Practice compliance assures the public that research participants' rights, safety, and well-being are adequately harnessed and also guarantees the reliability of generated data. This certificate training program aims to enhance the conceptual knowledge of the participant about Good Clinical Practice and resolve queries that a working professional may have about the application of GCP guidelines at his workplace. Successful performance in this program shall imply that a participant has in-depth knowledge of industry guidelines and regulations with a clear understanding. The course is thus meticulously designed to introduce the participant to various facets and fundamentals of GCP, its needs, and its benefits in assuring the ethical and scientific integrity of clinical trials.

Compliance with GCP gives assurance that the rights, safety, and well-being of trial subjects are protected and that the results of clinical trials are credible. Special topics have been further added to help the participant understand ICH GCP regulations and compliance needs, Indian GCP guidelines versus ICH GCP guidelines, etc.

Ideal for New & Experienced Professionals

This program is, therefore, an ideal solution for GCP training compliance for experienced professionals. Having developed a sound professional foundation of knowledge and application of GCP, one should quickly and efficiently progress through the scenarios and easily get back to work. For those new to the field, this GCP training provides an engaging way to develop GCP competencies.

Training effectiveness is measured by online assessment for those who have completed the GCP training workshop.

Workshop Format:

One or two-day workshop
Presentations by experienced trainers
Evaluation and certification
Training material for support

Online assessment

Assessment & Certification

Online assessment shall be carried out in the form of a Quiz at the end of the programme and after successful completion; the participants will be awarded a Certificate in Good Clinical Practice by GAADS. It is required that users complete a quiz following each module. To receive a certificate, all participants must be completed with at least 80% accuracy; a 100% pass option is available if your EC/IRB requires this. GCP training should be refreshed at a minimum every three years to keep regulations, standards, and guidelines updated.

Module	Topics
1	Ethics evolution in clinical research
2	ICHGCP
3	Fundamentals of Clinical Trial Operations
4	Ethics Committee Formation & Registration
5	Responsibilities of Sponsor
6	Responsibilities of Investigators
7	Responsibilities of Ethics Committee as per ICHGCP
8	ICMR Guidelines
9	Clinical Trial Protocol
10	Inform Consent
11	Trial Master File
12	Ethical Considerations & Subject Recruitment & Compensation Issues
13	Review of study documents & Decision-making
14	Project Management
15	EC, Standard operating procedure & Documentation
16	Global Regulations of Clinical Trials
17	Audits & Inspections

F.A.Q

Frequently Asked Questions

What is GCP in research?

GCP is an international set of ethical and scientific quality requirements for designing, conducting, recording, and reporting research that involves human participation.

What is the purpose of Good Clinical Practice?

Good Clinical Practice is an international ethical and quality standard relating to the design, implementation, execution, monitoring, auditing, registration, analyses, and reporting of clinical trials. It also targets the protection of rights, safety, and confidentiality of subjects involved in clinical trials.

What are the objectives for GCP training?

This training has been conducted with the objectives to equip the learner with knowledge and skills to conduct a good quality clinical research study that meets the regulatory requirements and generates reliable data.

Is participation in GCP training mandatory?

At a minimum, all study staff who have submitted a sketch must complete GCP training. The objectives of GCP are to assist in the protection of research participants from harm and to provide assurance of the quality and accuracy of data acquired during a clinical investigation, as well as to protect the quality and reliability of the data that arises from such trials.

What are the benefits of GCP training?

GCP guidelines ensure that the clinical data generated in a trial are verifiable, accurate, and reproducible. Compliance with GCP will move science forward while ensuring public well-being, safety, and confidentiality.

Who needs to complete GCP training?

All investigators and study staff participating in conduct, sponsor-investigator-oversight or management of clinical trials are required to complete Good Clinical Practice training and update this training every 3 years, as per the principles outlined by the ICH E6 (R2).

Why is GCP training important?

GCP guidelines ensure that clinical data generated during a trial are verifiable, accurate, and reproducible. Therefore, compliance with GCP is a precondition if the scientific community needs to progress further and protect the well-being, safety, and confidentiality of public sectors from possible inadequacies.

Which of the following best describes GCP?

Good Clinical Practice (GCP) refers to the ethical and scientific quality requirements that are internationally recognized, which must be observed when designing, conducting, recording, and reporting clinical trials involving humans.

How to download the GCP certificate?

1. Create your account and log in. Kindly ensure that you have filled in your correct details, e.g., name.
2. Take the training, and after training, go to the Q&A section.
3. Take the quiz.
4. Secure a minimum of 80% to pass the test.
5. Click on download certificate.
6. Download the GCP certificate post-test passage.

Contact

Call Us

+91-9818021037

Email Us

support@gaads.in

Address

Block A, 2nd Floor, Plot No. 11, Palam Extension,
Sector 7 Dwarka, Delhi-110075 India