Train personnel required for study
- As you work to on-board personnel for your clinical research projects it is vital that you keep documentation of all study staff training. General staff training may be documented with resumes/CVs, licenses, etc. In addition, study specific documentation of training would include minutes of the study initiation meeting attended by all study staff where the protocol and staff responsibilities are reviewed.
- Prior to participating in the conduct of human-subject research, all investigators and research personnel must complete the Partners Human Research Committee (PHRC) approved basic education program developed by the Collaborative Institutional Training Initiative (CITI).
- Additional training requirements vary based on the duties assigned to the study staff.
- Training should not just occur at the initiation of the protocol, but throughout the course of the study.
- It is the obligation of the investigator to ensure that all study staff have the proper qualifications, training and supervision to perform their duties.
▪ Clinical Research Program Clinical Research Coordinator Orientation Checklist
▪ Clinical Research Program Training Guide
▪ Collaborative Institutional Training Initiative (CITI) Program
▪ Harvard Catalyst Education and Training
▪ How to Explain Non-Credentialed MD’s Roles to Research Subjects
▪ Human Subject Protection Education and Training Requirements for Investigators and Study Staff
▪ MGH Clinical Research Program Education Unit
▪ MGH Research Staff Certification (Doctors Not Credentialed to Practice at MGH)
▪ Partners QI Program Study Staff Training Log
▪ Principal Investigators and Delegation of Study-Related Tasks to Co-Investigators and Study Staff
▪ eIRB Computer Based Training Modules
▪ Good Clinical Practice and Study Management Basics
▪ IATA Shipping Training for Transportation of Biological Materials and Dry Ice
▪ Infection Control Principles and Practice Training
▪ Introduction to Clinical Research at MGH