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Train personnel required for study

Information:

  • 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.

Resources:

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

Courses:

ONLINE:
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
IRB HIPAA Training

LIVE TRAINING:
Bio-Specimen Processing Basics
Clinical Skills Training: Phlebotomy
ECG
Vitals

Please click here for a list of CRP current offerings. Many of the CRP's courses are recorded, click here to access our recordings and handouts