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It is the obligation of the Principal Investigator (PI) to ensure that all study staff have the qualifications and training needed to conduct their research in accordance with the study protocol.
Training should not just occur at the initiation of the protocol, but throughout the course of the study. It is the obligation of the principal investigator (PI) to ensure that all study staff have the proper qualifications, training and supervision to perform their duties.
As you bring personnel on board for your clinical research project, 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 should include the minutes of the study initiation meeting attended by all study staff. This is the meeting where all 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 HealthCare Human Research Committee (PHRC)-approved basic Human Subjects Protection Education Program.
Mandatory training requirements have also been implemented for individuals functioning in the role of a research coordinator on clinical research studies at Mass General. Required courses are sent directly to new hires via Healthstream.
Additional training requirements vary based on the duties assigned to study staff.
The Division of Clinical Research (DCR) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.
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