Megha's Journey in Clinical Research

Table of Contents

1. Introduction
2. Megha's Background and Career Choice
3. Reasons for Choosing Clinical Research and Clinical Data Management
4. Clinical Research and Its Importance
5. Good Clinical Practice (GCP) Guidelines
6. Essential Documents in Clinical Research
7. Serious Adverse Events (SAE)
8. Ethics Committee and Its Composition
9. Clinical Research Associate (CRA) vs Clinical Research Coordinator (CRC)
10. SUGAM Portal and Clinical Trial Registry of India (CTRI)
11. Phase 1 Clinical Trials
12. International Conference on Harmonisation (ICH) Guidelines
13. Responsibilities of a Clinical Research Coordinator (CRC)
14. Conclusion

Megha's Journey in Clinical Research and Clinical Data Management

Megha is a young professional who has completed her PSC honors degree in Anastasia and operation theater technology from Ramayan University in 2022. She is currently pursuing an advanced diploma in clinical research and clinical data management from Plain Women's Institute. In this article, we will explore Megha's Journey in clinical research and clinical data management, her reasons for choosing this career path, and the importance of clinical research.

Megha's Background and Career Choice

Megha's interest in the medical field led her to pursue a course in Anastasia. However, she soon realized that there was limited career growth in this field, and the salary growth was also minimal. After researching various medical-related fields, she came across clinical research and found it to be very interesting. Megha had exposure to operation theater from her Second year of college, where she worked as an Anastasia technician in the hospital. During this time, she talked to doctors, anesthetists, and other medical professionals, which piqued her interest in clinical research.

Reasons for Choosing Clinical Research and Clinical Data Management

Clinical research is a process that assesses the safety and efficacy parameters of any new drug, device, or intervention for human use. Megha found clinical research to be a fascinating field due to its vast scope and job opportunities. India is becoming one of the favorable destinations for clinical trials due to its large patient pool. Megha believes that clinical research will give her the opportunity to work in many great MNCs and provide her with a challenging and rewarding career.

Clinical Research and Its Importance

Clinical research is essential for the development of new drugs, devices, and interventions. It helps to determine the safety and efficacy of these products before they are made available to the public. Clinical research also plays a crucial role in advancing medical knowledge and improving patient care. It is a highly regulated field, and adherence to Good Clinical Practice (GCP) guidelines is mandatory.

Good Clinical Practice (GCP) Guidelines

GCP guidelines are a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials. The guidelines ensure that the rights, safety, and well-being of trial subjects are protected, and the data generated is reliable and credible. GCP guidelines cover various topics, including the responsibilities of sponsors, investigators, and monitors, protocol and protocol amendments, investigator brochure, and essential documents.

Essential Documents in Clinical Research

Essential documents are documents that permit the evaluation of the conduct of the trial and the quality of the data produced. They assess whether the sponsor, investigator, and monitor have been conducting the trial in compliance with GCP and other regulatory requirements. Essential documents include the protocol, informed consent form, case report form, and investigator's brochure.

Serious Adverse Events (SAE)

Serious adverse events are adverse events that can result in death, life-threatening situations, hospitalization for more than 24 hours, prolonged hospitalization, disability, or congenital disorders. SAEs must be reported to the sponsor, Ethics Committee, and regulatory authorities.

Ethics Committee and Its Composition

The Ethics Committee is responsible for protecting the rights, safety, and well-being of trial subjects. It is composed of a minimum of seven members, including a chairperson, member secretary, medical scientist, clinician, legal expert, police person, and social worker. The Ethics Committee reviews and approves the protocol, informed consent form, and other study-related documents.

Clinical Research Associate (CRA) vs Clinical Research Coordinator (CRC)

A CRA is responsible for overseeing the conduct of the trial to ensure compliance with the protocol, GCP, and regulatory requirements. A CRC is a professional who works under the principal investigator and coordinates the day-to-day activities of the clinical trial. They are responsible for scheduling patient visits, data clarification, and ensuring compliance with the protocol.

SUGAM Portal and Clinical Trial Registry of India (CTRI)

SUGAM Portal is an online licensing portal implemented by CDSCO in January 2016. It allows for online application submission, review, and grant of permission and NOC. CTRI is the clinical trial registry of India, and all clinical trials conducted in India must be registered on this site before publication.

Phase 1 Clinical Trials

Phase 1 clinical trials are the first phase of human pharmacological testing. They involve 20 to 80 healthy volunteers and are conducted to test the safety, PK and PD parameters, and tolerance of the investigational product.

International Conference on Harmonisation (ICH) Guidelines

ICH guidelines are a set of guidelines that cover various topics related to clinical research. They include guidelines on quality, efficacy, safety, and multi-disciplinary topics.

Responsibilities of a Clinical Research Coordinator (CRC)

A CRC is responsible for coordinating the day-to-day activities of the clinical trial. They work under the principal investigator and are responsible for answering the feasibility questionnaire, resolving subject queries, and ensuring compliance with the protocol. They also assist with the informed consent process and ensure that the monitor receives all the required reports and records.

Conclusion

Clinical research and clinical data management are exciting and challenging fields that offer vast job opportunities. Megha's journey in clinical research is an inspiration to many young professionals who are looking to make a career in this field. Adherence to GCP guidelines, essential documents, and Ethics Committee composition are crucial for the success of clinical trials. The role of a CRC is essential in coordinating the day-to-day activities of the clinical trial.