GCP Training

The ICH-GCP guidelines are developed to facilitate an international ethical and scientific quality standard for planning, executing, supervising, documenting, auditing, examining and reporting bio-medical and behavioural research studies concerning human population. The ICH-GCP guidelines provide platform to the industry in form of two basic standards: protecting the rights, safety and welfare of human subjects; and the genuineness of the data generated by the research.ICH-GCP guidelines confer objective to provide one single standard to facilitate the conduct of clinical trials across the US, European Union & Japan. Hence Good Clinical Practice (GCP) is an international ethical and quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the rights, safety, and well-being of human research participants are well protected, data and reported results are credible and accurate.

Creating awareness of GCP is mandatory when it comes to innovation in medicine and healthcare. The recent launch of the New Drugs and Clinical Trials Rules, 2019 (NDCT), on March 19, 2019, opens up a new set of opportunities to accelerate innovations in India. Alongside are the challenges to ensure that the rules are widely disseminated, properly explained and correctly interpreted. Poor understanding of the current regulatory requirements (mainly the do’s and don’ts) mixed with inadequate compliance to best global practices may lead to delays and failures (financial & non-financial loss) which can be significantly reduced through awareness and empowerment through such programmes.

Team GSER is actively involved in taking various initiatives towards knowledge dissemination and training for clinical research professionals. Our training classes cum workshops are designed according to latest guidelines and updates and addressing all major requirements set aside by industry experts. Our GCP workshop is ideal for professionals who wish to attain effective good clinical practice skills in compliance with applicable regulatory guidelines.

GCP is a basic acceptable standard for working as a clinical research professional. Getting Good Clinical Practice certified has multiple advantages such as:

• Various pharmaceutical/ biotech and clinical research organizations recommend GCP certification to their employees.

• Organizations are hiring professionals certified in GCP for planning and conducting GCP audits (vendor, internal process and investigator site) and may include responsibilities for providing Quality Assurance support to clinical operations.

• Good clinical Practice (GCP) training is important for organizations in the business of clinical research so that they can comply with the industry guidelines, and regulations.

Topics for GCP Training cum Workshop:

• Overview of Good Clinical Practice (Basic Introduction to ICH GCP & Overview of New Revision, Principles of ICH GCP).
• Essential Documents (Informed Consent, Protocol, Investigator’s Brochure).
• Discussion on SAE Reporting, Audit & Inspection, Investigational Product – Accountability.
• Consequences of GCP non-compliance.
• Case Studies Discussion- Integrating GCP principles in Clinical Research Conduct.
• Difference between Indian GCP and ICH GCP.
• New Drugs and Clinical Trials Rules (2019): Salient features.
• National ethical guidelines for biomedical and health research involving human participants (2017).
• Ethics committee: registration and re-registration.
• Accreditation standards for ethics committees.
• Roles and responsibilities of all stakeholders: Sponsor, Monitor, Institution, Investigator.
• Clinical trial documentation.
• Record keeping and data handling.
• Questions and & Answers session.

During workshop, participants shall learn about:

1. The principles of GCP, roles and responsibilities of various stakeholders involved in a clinical research/trial.
2. Current ethical and regulatory requirements for conducting clinical research/trial in India.
3. Salient features of the New Drugs and Clinical Trials Rules, 2019.
4. National ethical guidelines for biomedical and health research involving human participants, 2017 and the national ethical guidelines for biomedical research involving children, 2017.
5. Various requirements for seeking registration, re-registration of ethics committees and accreditation standards.

At the end of workshop, the participants shall be able to:

1. Understand the GCP principles.
2. Seek cognizance of the regulations and guidelines that govern human research in India.
3. Know the best practices in clinical trials/research.
4. Understand and distinguish ‘rights’ from ‘wrong’ approaches.
5. Get an opportunity to clarify doubts about the implementation of GCP.