Training & Еducation

Convex Ltd. offers educational program, specifically designed for new staffs who wish to improve their competency in the field of clinical research management.

The courses specifically address local implementation of GCP in performing day-to-day clinical research activities. It is intended for clinical research coordinator,

study nurses, clinical research associates.  The training program is focused on resolving problems encountered in research staff work day environment as they

arise. It is organized into several modules as listed below. Topics covered are:

 

 

Clinical Research Associate

 

1.     What Is a CRA?

2.     Regulations and GCP

3.     Roles and Responsibilities in Clinical Trials

4.     The Research Process

5.     Devices and Biologics

6.     Globalization of Clinical Trials

7.     Institutional Review Boards and Data

8.     Informed Consent

9.     Study Design and Statistical Issues

10.   Protocols, CRF and EDC

11.   Clinical Investigators

12.   Study Initiation

13.   Study Monitoring

14.   AEs and Safety Monitoring Regulations

15.   Recruitment, Retention and Compliance                     

16.   Study Closeout

17.   Audits

18.   Errors, Misconduct and Fraud

 

Clinical Research Coordinator

 

1.     The Clinical Research Coordinator

2.    IRBs and DSMBs

3.     Informed Consent

4.     Regulations and Good Clinical Practice

5.     An Overview of Research

6.     Devices and Biologics

7.     Standard Operating Procedures

8.     Preparing for a Study

9.     Protocols

10.   CRFs and EDC

11.   Investigational Product Accountability

12.   Working with Study Subjects 

13.   Study Closure

14.   Adverse Events (AEs) and Safety Monitoring              

15.   Audits

 

Study Nurse

 

1.       General Information

2.       Landing Your First Study 

3.       Feasibility, Budgets and Contracts 

4.       Regulatory Issues

5.       Study Start-Up

6.       Study Activities: Strategies and Tools   

7.       The State of the Industry – prospect