Clinical Research Certification Online

 
 

ICH GCP TRAINING 

The ICH GCP training modules go over the entire ICH GCP guidelines in detail. They teach you how to apply them rather than just understand the protocols. This is the essential basis of Clinical Research Training.

clinical research training

1. An Overview of ICH GCP

2. Duties and Responsibilities of a Clinical Research Associate

3. Ethics of Research Involving Children

4. Ethics of Research Involving Mentally Incapacitated

5. Ethics of Research Involving Pregnant Women and Fetuses

6. Ethics of Research Involving Prisoners

7. FDA 21 CFR 11

8. ICG GCP 5.5 Trial Management – Data Handling and Record Retention

9. ICH GCP E6 and E2A - Adverse Events

10. ICH GCP E6 Section 4 - Investigators Responsibilities

11. ICH GCP E6 Section 4 - Investigators Responsibilities – Informed Consent Form

12. ICH GCP E6 Section 5 - Sponsors Responsibilities

13. Introduction to Clinical Research

14. Reporting Responsibilities of the Investigator

15. Safety of Human Subjects in Research

Length

15 Modules

availability

Within 24 Hours of Tuition Payment

 

QUALITY MONITORING 

The quality monitoring modules are needed to work as a supervisor on clinical trials. This is the section not available in any other entry or introductory clinical research training course with more detail than many new Senior CRAs know. These modules allow you to obtain the application, examples, and guidelines needed to monitor trials with ease in your new position.

Clinical Research Courses Online

1. Designs of Clinical Trials

2. Phases of Clinical Trials

3. Pre - Clinical Trials

4. Stakeholders in Clinical Research and Their Relationships

5. Randomized Controlled Trials

6. Types of Monitoring Visits

7. Site and Investigator Selection

8. Site Qualification Visit

9. Routine Monitoring Visits

10. Investigators Meetings

11. Checklists for Pharmacy Monitoring and Inspection Visits

12. Monitoring and Auditing of Clinical Trials

13. Site Close Out Visit

14. Source Documents

15. Inclusion Exclusion Criterion in Clinical R esearch

16. Protocol in Clinical Research

17. Protocol Deviations and Violations

18. Institutional Review Board

19. Quality Control in Clinical Research

20. Data Safety Monitoring board - DSMB

21. An Overview of Remote Monitoring

22. Centralized Versus Onsite Monitoring

23. Electronic Data Capture and Remote Data Capture Basics

24. Remote Monitoring of Clinical Trials and EMRs

25. Blinding in Clinical Trials

26. Communication between Blinded and Unblinded Staff

27. Investigational Product Storage and Dispensing

28. Investigational Product Accountability in Clinical Trials

29. Adverse Drug Reactions

30. Basics of Adverse Event Monitoring

31. Adverse Event Reporting

32. Based Monitoring

33. Monitoring Tools and Notes

34. Pharmacovigilance ( Part 1 and 2)

35. Minimizing Source Data Queries in Clinical trials

36. Investigator Initiated Multi Center Trails

37. IND and NDA Process

38. Guidelines for Designing and Completing Case Report Forms

39. Do’s and Dont’s of a Case Report Form Design

40. Introduction to Bioresearch Monitoring

41. Clinical Trial Management System - CTMS

42. Minimizing Source Data Queries in Clinical Trials

43. Drug Development in the US and FDA Approval Procedures

44. Code of Federal regulations

45. Role of Local and Central Labs in Clinical Trials

Length

45 Modules

Availability

After Completion of ICH GCP Training

 

REGULATORY TRAINING  

Regulatory training allows you to understand and apply the FDA regulation guidelines to each individual trial you will supervise after your Clinical Research Training.

clinical research training online

1. Regulatory Documents in Clinical Research

2. Regulatory Affairs

3. Essential Regulatory Documents Guidance and Binder Tabs ( Part 1 and Part 2)

4. Electronic Regulatory Submission and Review

5. Financial Disclosure - Duties and Strategies for Clinical Studies

6. Financial Disclosures and Conflicts of Interest in Clinical Research

7. FDA Form 1572 ( Part 1 and Part 2)

8. Investigators Brochure

9. Protocol Review and Approval Process

10. Safety Reporting Requirements for Sponsor Investigators

11. IND Application

12. IND Safety Reporting Requirements – Tip She ets

13. Schedule Y

14. Trial Master File Reference

15. Trial Master File and DIA Model


Length

15 Modules

Availability

After Completion of Quality Monitoring Training

 

AUDIT AND INSPECTIONS  

The auditing and inspections modules train you to prepare clinical trials for auditing by your company, government organization, or academic organization after your Clinical Research Training.

clinical research training online

1. Audits and Inspections in Clinical Trials

2. FDA Warning Letter

3. Site FDA Audit Inspection Checklist

4. Things to Remember during an FDA Inspection

5. How to Survive Through and FDA Inspection

6. Do and Dont’s of a FDA Inspection

Length

6 Modules

Availability

After Completion of Regulatory Trainin

 

Subject Recruitment, Retention and Compliance – 5 Modules

Clinical Research Courses Online

1. Compliance Requirements in Clinical Trials

2. Subject Recruitment and Retention ( Part 1 and Part 2)

3. Increasing Subject Compliance in Clinical Trials

4. Ethical Consideration Associated with Investigator Payment and Patient Recruitment

5. Advertisement aid in Subject Recruitment and Retention

Length

5 Modules

Availability

After Completion of Audit Training

 

Misconduct and Fraud – 2 Modules

clinical research training online

1. Scientific Misconduct in Research and How to Prevent It

2. Misconduct in Research – Detecting Falsification

Length

2 Modules

Availability

After Completion of Subject Rec

 

WRITING MONITORING REPORTS & FOLLOW UP LETTERS

These modules immerse you in understanding, applying, and learning to write monitoring reports, follow up letters, and professional write-ups required in the CRA position after each clinical site visit or review after your Clinical Research Training.

Clinical Research Courses Online

1. Checklist of Activities for Prestudy Qualification

2. Prestudy Visit and Monitoring Questionnaire

3. Prestudy Visit Follow Up Letter

4. Prestudy Visit Follow Up Letter

5. Site Initiation Visit Agenda

6. Site Initiation Visit Confirmation Letter

7. Site Initiation Visit Report

8. Site Initiation Visit Follow Up Letter

9. Site’s Assigned Monitor change Letter

10. Site Monitorin g Visit Confirmation Letter/Fax

11. Site Monitoring Visit Report

12. Site Monitoring Visit Follow Up Letter

13. Site Close Out Visit Confirmation Letter

14. Site Close out Visit Agenda

15. Site Close Out Visit Report

16. Site Close Out Visit Follow Up Letter

Length

16 Modules

Availability

After Completion of Audit & Inspections Training

 

COMPETENCY TESTING OF CRA   

This is the competency testing of your Clinical Research Training modules is the next course needed to ensure you are ready for CRA examination after your CRA career. We establish our CRA’s as future leaders in the clinical trial space by ensuring you have the full education needed to be promoted in your career quicker than without the course.

20 Questions Per Block


Clinical Research Courses Online

Included With Enrollment

CRA LETTER OF REFERENCE

Our top clinical trial supervisor offers interviewing and letters of reference upon approval based on your success in the course.

CRA INTERVIEW PREPARATION

Dr.Kamal works with each student to prepare them for up to 3 rounds of interviews they will face when applying for the CRA position. These video conferencing sessions are essential in developing the right dialect needed to convey the experience and readiness for the position.

Length

6 Modules

Availability

After Completion of WRM & FUL Training