MLC College – Clinical Research Associate

LESSON 1

• WHAT IS A CLINICAL TRIAL? (Clinical Study)
• WHAT IS A CRA? WHO CAN BE A CRA?

LESSON 2

• PHARMACEUTICAL INDUSTRY AND THE DRUG DEVELOPMENT PROCESS.
• COMPLEX CLINICAL RESEARCH REGULATIONS, WHY?

LESSON 3

• INDEPENDENT ETHICS COMMITTEE (IEC) INSTITUTIONAL REVIEW BOARD (IRB) PROCESS

LESSON 4

• THE INFORMED CONSENT

LESSON 5

• INVESTIGATOR SITE SELECTION AND QUALIFICATION VISITS

LESSON 6

• SITE INITIATION – PREPARATION & VISITS

LESSON 7

• MONITORING INVESTIGATIONAL SITES

LESSON 8

• ADVERSE EVENTS & SAFETY MONITORING

LESSON 9

• STUDY TERMINATION VISITS

LESSON 10

• THE STUDY PROTOCOL
• ELECTRONIC DATA CAPTURE in clinical research
• PATIENT RETENTION & COMPLIANCE