Venue:

Online Platform

Class Hours:

5-7hrs  Per Week 

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+44 7907 794049

US Contact:

+1 (470) 854-4689

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We offer the Best!

Comprehensive and Practical Learning

Participate in hands-on workshops led by experienced professionals who bring real-world expertise to the training environment.

Career Development & Support

We understand the importance of career development in clinical research. Our institute offers comprehensive career support services, including resume reviews, interview preparation, and access to job boards and networking opportunities.

Certification Program

Elevate your credentials and demonstrate your expertise in clinical research with our certification programs. Our certification courses validate your knowledge and skills, providing a competitive edge in the job market.

Program
Breakdown

Week 1

Learning Outcome and Goal:

• Experience of medicines and it’s development
• Research and discovery stage & product development
• Clinical development
• Regulatory submission, Health Technology Assessment.
• ICH GCP certification


BONUS 1: Activities In Oncology: 

There are numerous indications in oncology, as cancer can affect various organs and tissues in the body. Some common indications in oncology include Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Cervical Cancer, Leukemia, Pancreatic Cancer, Ovarian Cancer, Bladder Cancer, Kidney Cancer, Brain tumors, and more. Each type of cancer may have different subtypes and stages, leading to diverse treatment approaches.

Career Prospects

Oncology remains an ever-evolving field with ongoing research and advancements aimed at improving diagnosis, treatment, and patient outcomes, making it a pivotal area of clinical research with significant potential for improving healthcare.” part under clinical research.

Week 2

Clinical Researcher Roles and Responsibilities

Learning outcome and Goal

•Study Protocol, Roles and Responsibilities of a CRA
• Ethics Committees (IRB/IEC)
• Sponsor / Monitor (SDV, SDR, ALCOA-C)
• Investigator/Principal investigator (PI)
• Competent/ Other Relevant local Authority 

 

BONUS 2: Activities in Cardiology

Cardiology focuses on understanding and treating various heart diseases. Some common indications in cardiology include Coronary Artery Disease, Heart Failure, Atrial Fibrillation, Hypertension, and Myocardial Infarction (Heart Attack). 

Career Prospects

With the constant stream of advancements in treatment options, cardiology remains at the forefront of clinical research, offering opportunities to enhance cardiovascular care and patient outcomes.

Week 3

Choosing and Initiating Clinical Trial Sites

Learning Outcome and Goal

• comprehend the qualities of a good investigator site
• understand the purpose of an initiation visit
• design and organize appropriate training for trial site staff
• monitor, recognized issues and escalate problems as needed
• Inspire investigator sites in patient recruitment using ethical methods

BONUS 3: Activities in Neurology

There are diverse neurological conditions that encompass disorders of the nervous system. Some common indications in neurology include Alzheimer’s Disease, Parkinson’s Disease, Multiple Sclerosis, Stroke, and Epilepsy. 

Career Prospects 

Each condition requires specialized research and treatment approaches, making neurology a critical area of clinical research with potential for significant medical advancements.”

Week 4

Monitoring/Closing of Clinical Trial Sites

Learning Outcome and Goal

• understand the reason of monitoring clinical trials
• organize and conduct good monitoring clinical visits
• follow up on identified issues and escalate problems as needed
• evaluate site performance and develop strategies for enhancement performance as needed
• prepare and conduct effective close-out clinical site

BONUS 4: Activities In Infectious diseases 

Infectious Diseases research involves studying various infectious agents like viruses, bacteria, and parasites. Common indications include Influenza (Flu), HIV/AIDS, Tuberculosis (TB), Malaria, Hepatitis, and more. Researchers in this field develop effective vaccines, antimicrobial therapies, and prevention strategies to combat infectious diseases. 

Career Opportunities

With the ever-present threat of emerging pathogens, a career in Infectious Diseases research offers a rewarding opportunity to contribute to global health, outbreak control, and public health policies. It’s a very viable field in clinical research.

Week 5

Subject/participants Protection, Adverse Events (AE), Serious Adverse Events (SAE), Adverse Drug Reaction (ADR) and ICF.

Learning Outcomes and Goal

  • Conducting subject recruitment in proper manner as per protocol and GCP-ICH.
    • Documenting participants information and ensuring that confidentiality is protected for each trial subject 
  • recognize issues that might affect participants safety and clinical trial data integrity at the PI site such as protocol deviation/violations and pharmacovigilance issues
  •  understand the reporting requirements for and adverse events whether related or not related to the IP/IMD(investigational product/investigational medical product)

BONUS 5: Activities In Immunology

Immunology research delves into understanding the immune system’s role in health and disease. Common indications include Rheumatoid Arthritis, Crohn’s Disease, Organ Transplant Rejection, Allergies, and Immunodeficiency Disorders. Immunologists explore innovative immunotherapies and personalized treatments to revolutionize patient care. 

Career Prospect

With the rapid advancements in immunology, a career in this field offers exciting opportunities to contribute to breakthroughs in autoimmune diseases, organ transplantation, and cutting-edge immunotherapies, leading to improved patient outcomes and quality of life.

Week 6

Investigational Medicinal Product Management

Learning Outcomes and Goal

• recognize the responsibilities of the Sponsor, the Monitor(CRA) and the Investigator towards the IP
• IP reconciliation at the beginning and end of the trial
• understand what randomisation and blinding processes is using the IWRS
• Need for randomization and blinding
• know how to monitor IP-related aspects during your monitoring visits (drug accountability, randomization of patients, storage conditions and access control, re-supplies and shipment, expiry date and related documentation)

BONUS 6: Activities in Respiratory Medicine 

Respiratory Medicine research focuses on studying various respiratory conditions. Common indications include Asthma, Chronic Obstructive Pulmonary Disease (COPD), Lung Cancer, Pneumonia, and Pulmonary Fibrosis. Researchers in this field explore innovative interventions, such as inhalers and pulmonary rehabilitation, to enhance respiratory health. 

Career Prospects

Due to the growing prevalence of respiratory diseases, a career in Respiratory Medicine offers promising opportunities to advance treatments, improve lung health, and positively impact patients’ lives.

Week 7

Data Management for Clinical Research Associates

Learning Outcomes and Goal

• understand the purpose and structure of a Case Report Form (CRF)

• the process for accurate data collection and reporting

• ensure that the investigator site is aware of the requirement of archiving of essential documents in accordance with applicable guidelines and regulations

Bonus 7: Activities in Endocrinology 

Endocrinology research centers on studying hormonal disorders. Common indications include Type 2 Diabetes Mellitus, Hypothyroidism, Cushing’s Syndrome, Polycystic Ovary Syndrome (PCOS), and Growth Hormone Deficiency. Researchers in this field aim to optimize hormonal management and develop innovative therapies. 

 

Career Prospects

Given the increasing prevalence of endocrine disorders, a career in Endocrinology offers rewarding opportunities to contribute to the advancement of treatments and positively impact patients’ well-being and overall health.

WEEK 8 

Revision and Examination

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