Coming Soon


MGH Division of Clinical Research

QI Roundtable - Study Start-Up

Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speaker: Daniel Jones, QA/QI Speacialist Isabel Chico-Calero, QI Program Regulatory Specialist This series is designed for all …

MGH Division of Clinical Research

QI Roundtable: Source Documentation

Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speaker: Stephen Hayes, Partners Human Research, Senior QA/QI Specialist Per Federal Regulations, Good Clinical Practice, and Partners …

MGH Division of Clinical Research

QI Roundtable: Protocol Adherence and Reporting Requirements

Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speaker: Isabel Chico Calero, QI Program Regulatory Specialist You are working on an exciting new study. Are …

MGH Division of Clinical Research

QI Roundtable: Consent Process

Speaker: Daniel Jones, QI Specialist Informed consent: it’s more than just a document. Do you know the ethical considerations that factor into obtaining truly informed consent? If your study involves vulnerable populations, such as children, are you knowledgeable of the …

No Current Offerings


MGH Division of Clinical Research

Maintaining a Regulatory Binder is not as Easy as it Seems!

Every study should have a regulatory binder or file whether survey research or drug/device clinical trials. There is a standard set of documents referred to as “essential documents” that should be filed and maintained in the regulatory binder. In this …

MGH Division of Clinical Research

QI Bootcamp: Informed Consent: It’s More than just a Document!

Do you know the ethical considerations that factor into obtaining truly informed consent? If your study involves vulnerable populations, such as children, are you knowledgeable of the special protections afforded to them? Are you aware of federal regulations and IRB …

MGH Division of Clinical Research

QI Bootcamp: Investigational Product Accountability: What is this and How do I do it?

Many drug and device clinical trials are conducted at Partners Institutions. Study teams have the option of using the investigational drug service to manage study drug accountably or storing and managing accountably onsite. For device trials often the only option …

MGH Division of Clinical Research

QI Bootcamp: Navigating the Vast Realm of Unanticipated Problems, Deviations and Violations!

What is an unanticipated problem? Is it more than just an adverse event? When is it a deviation? When is it a violation? In this session, we will discuss events that constitute an “unanticipated problem,” regulations governing unanticipated problems and …

MGH Division of Clinical Research

QI Bootcamp: Session of the Unknown!

As part of the registration process participants will be asked to list a topic or two related to the regulations, study implementation, audits etc. that they have struggled with or would like to learn more about. Participants are welcome to …

MGH Division of Clinical Research

QI Bootcamp: Study Documentation: If it isn’t Documented it Didn’t Happen!

Per Federal Regulations, Good Clinical Practice, and IRB policies, investigators and research staff are required to keep case histories on enrolled subjects. In this session, we will review requirements for source documentation and record keeping of subject files. The presentation …

MGH Division of Clinical Research

QI Bootcamp: What is the Quality Improvement (QI) Program?

The Partners Human Research Quality Improvement (QI) Program provides education and support to the Partners research community to ensure the optimal conduct of human research within the framework of federal regulations, institutional policies, and good clinical practice. In this session, …

MGH Division of Clinical Research

Recent FDA Inspections at MGH: Observations, Citations, and Lessons Learned

Speaker: Pamela Richtmyer, Senior Research Compliance Associate, MGH Research Compliance Please join us as Pamela Richtmyer discusses recent FDA inspections at MGH, lesson learned from those inspections and how we can prevent citations moving forward. This course is geared towards …

MGH Division of Clinical Research

Spotlight Series: ICH E6 Guideline Revisions

Sponsored by the MGH Division of Clinical Research Daniel Jones, MSN RN Senior QA/QI Specialist of the Partners Quality Improvement Program Did you know that the E6 Guidelines were revised and adopted by ICH on 12/15/2016? Who do these revisions …

MGH Division of Clinical Research

Virtual Visits

Virtual Visits Friday, June 5| 9:00-10:30am | Via Zoom Speaker: Pamela Richtmyer, Director, Partners Human Research Quality Improvement Program The Virtual Clinical Research Visits course will discuss best practices and special considerations for remote clinical research study visits including obtaining …