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Review PI and staff roles and responsibilities

Information:

  • The Principal Investigator (PI) is responsible for the conduct of his/her studies. S/he may delegate certain duties to co-investigators and other members of the study team, but may not delegate the responsibility for assuring that the study is performed as per the protocol.
  • It is key that PIs understand the regulations about Delegation of Responsibility and that a Delegation of Responsibility Log be kept to catalogue all delegations that have occurred.

Resources:

How to Explain Non-Credentialed MD’s Roles to Research Subjects
MGH Research Staff Certification (Doctors Not Credentialed to Practice at MGH)
Partners QI Program Delegation of Responsibility Log
PHRC Guidance about PI Responsibilities
PHRC Investigator and Study Staff Information Sheet

Courses:

ONLINE:
Introduction to Clinical Research at MGH

LIVE TRAINING:
Clinical Research Spotlight Series: Communicating within Study Teams
Design and Conduct of Clinical Trials
FDA Inspections, 483's and Warning Letters: How to Avoid and Survive Them
Operationalizing Clinical Research Protocols
Research Misconduct
Sponsoring and Managing Multi-Center Clinical Trials

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.