Good clinical practice (GCP) guidelines apply to all types of clinical research. It’s imperative that clinical researchers and study staff are familiar with GCP to conduct clinical research safely, efficiently and remain in compliance. The goal of Partners Human Research Quality Improvement (QI) Program is provide education and support to the Partners research community to ensure the optimal conduct of human subjects research within the framework of federal regulations, institutional policies, and good clinical practice.
The Partners QI Program and the MGH Division of Clinical Research are excited to offer QI Bootcamp. The goal of QI Bootcamp is to review GCP guidelines and institutional policies, and instruct study staff on how to implement those guidelines and policies into the day to day conduct of clinical research. Session topics include:
• Introduction to the QI Program
• Informed consent
• Study documentation
• Unanticipated problems, adverse events and deviations/violations
• Investigational product accountability and storage (drug and device)
• Regulatory files
A seventh session will be added and the topic of that session will depend on the needs of participants. The group will be surveyed to determine topics they would like to know more about such as CT.gov, submitting an IND/IDE, audit readiness etc.
1. To review GCP guidelines and research related policies at MGH, BWH and Partners
2. To describe best practices for implementing GCP
3. To provide tools, checklists, and resources to assist with implementing GCP
QI Bootcamp is open to all clinical researchers and clinical research study staff.
QI Bootcamp will be limited to 30 participants. Sessions will be held weekly. The Program will be offered twice a year at MGH. A certificate of completion will be awarded to those who attend all sessions and successfully pass a post-course quiz. Participants are welcome to bring lunch to each session.
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: 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 …
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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: 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, …