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Human Subjects Research Recordkeeping and Record Retention
Speaker: Pamela Richtmyer, Director, Mass General Brigham Human Research Quality Improvement Program Description: Investigators are required to maintain records of their human research activities. Good recordkeeping is essential for verifying the integrity of study data produced and for demonstrating investigator …
Informed Consent including eConsent
Informed Consent including eConsent Speaker: Pamela Richtmyer, Director, Partners Human Research Quality Improvement Program This course is intended for investigators and research staff. In addition to covering the required elements of the informed consent, this course will address the following: …
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 …
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 …
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 …
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 …
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 …
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 …
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, …
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 …
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 …
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 …
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 …
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 …
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 …
Study Team Data Management and Internal QA Monitoring Plans
Speaker: Pamela Richtmyer, Director, Mass General Brigham Human Research Quality Improvement Program Description: During this presentation you will learn tips and tricks for effective management of study data and options for developing an internal quality assurance monitoring plan that will …
Virtual Visits
Virtual Visits Speaker: Pamela Richtmyer, Director, MGB 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 consent. We will also discuss documentation and …
Writing a Clinical Research Protocol
Writing a Clinical Research Protocol : This course is intended for investigators and research staff. A well written protocol is essential to successful and compliant clinical research. This course will address the following questions: • What are the required elements …