THE C.A.R.E. INITIATIVE

PROBLEM STATEMENT

There is growing demand for qualified clinical researchers to conduct trials on medical treatments and devices and people cannot afford or access clinical trials certification programs.

AIM

Provide free training and certification programs to help anyone interested master the practical aspects of running and managing a clinical trial, including trial design and phases, good clinical practices, the drug discovery and development process, and quality control and assurance.

OBJECTIVE

To support, develop, maintain, and renew scientific, human, and physical resources that will ensure international capability to prevent disease by offering free Training,  education and certification.

SOLUTION

Offer free of charge a certification on the Principles and Practice of Clinical Research (IPPCR)  on how to effectively and safely conduct clinical research. The program focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiological methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more.

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PFP’s Virtual learning platform that uses self-paced learning courses to enhance the knowledge and skill of patients, caregivers, patient advocates, patient-led organisations, healthcare workers, pharmacists, civil society organisations and NGOs globally. The courses we offered are:

SCALES OF ASSESSMENT

1. NIH Stroke Scale (NIHSSI) International – Training and Certification
2. TELEMEDICINE Best Practices when using the NIH Stroke Scale
3. The Columbia Suicidality Scale (C-SSRSI) – International Training
4. Modified Rankin Scale(mRS)- Instructions and Training – Not for Certification
5. Barthel Index (English) – Training Only – Not for Certification

 

COVID COURSES

1. Basic Corona Virus and COVID-19 Course

 

CLINICAL RESEARCH BASIC COURSES

1. The History of Clinical Research
2. Participant Recruitment for Beginners
3. Advanced Participant Recruitment
4. Clinical Research Site Study Close Out
5. Investigator Responsibilities
6. Regulatory Document Submission
7. Ethics In Clinical Research
8. Site Selection and Initiation Procedures
9. Building a Successful Clinical Research Site
10. The history of GCP • The purpose of GCP • The principles of GCP
11. The purpose of the Informed Consent • The content of he Informed Consent Form • The Informed Consent Process • How to obtain informed consent in accordance with ICH GCP
12. Requirements for Source Data and Source Documents. • The Essential Documents required for the conduct of a clinical trial. • The importance of good documentation practice.
13. The definition of Adverse Events -AEs- and Serious Adverse Events -SAEs • Understand the reporting timelines for AEs and SAEs • Understand the Investigator Obligations in reporting AEs and SAEs
14. The importance of good Investigational Product management • Investigator Responsibilities for Investigational Product management
15. The roles and responsibilities of the IRB-IEC • The required composition and function of the IRB-IEC as per ICHGCP The Investigators role in communication with the IRB-IEC

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Project Founder & Leader: Asligul Kendirci

                                                                                                                 Email [email protected] to learn more.