MGH Research Institute

Program Description

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.

Course Objectives:
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.



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