Agenda:
o Understand the key features of successful trial planning
o Identify potential challenges when preparing for a global clinical trial
o Explain how site selection can make or break a trial’s success
o Summarize the methods of evaluating sites for trial suitability
Target Audience:
Principal Investigators, CRC’s, Project Managers, and CRA’s.
Agenda:
o Objectives of a site selection visit (SSV)
o Status and availability of key study documents from sponsor
o Site specific documents needed at the SSV
o Establishing the PI and medical/support team required.
o Medical study site vs offsite facility and satellite site
Target Audience:
Principal Investigators, CRC’s, Project Managers, and CRA’s.
Agenda:
o Discuss the general concept of grant budget
o Understand the principle of building your research grant items
o Be able to know the essence of negotiation
Target Audience:
Principal Investigators, CRC’s, Project Managers, and CRA’s.
Agenda:
o Understand the history and fundamental principles of ICH GCP
o Have a knowledge and understanding of the investigator’s/IRB/IEC & Sponsor responsibilities
o Understand the expectations and requirements of ICH GCP in the conduct of clinical trials.
o Be able to implement the requirements of ICH GCP in the conduct of clinical trials
Target Audience:
Principal Investigators and Clinicians
