Review PI and staff roles and responsibilities
- 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.
▪ 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
▪ Introduction to Clinical Research at MGH
▪ 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