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 HRC policies, investigators and research staff are required to keep case histories on enrolled subjects. Stephen Hayes, Senior QA/QI Specialist will review requirements for source documentation and record keeping of subject files. The presentation will include a hypothetical protocol with enrolled subjects and its appropriate source documentation. Proper record keeping and study management will assist study staff with the annual Continuing Review process. This session is limited to 25 participants to facilitate interaction.
Please contact Tiereny Morrison-Rohlfs at tmorrison-rohlfs@partners.org with any questions
Programs: Beginner Clinical Research Coordinator Clinical Research Investigator
Categories: Clinical Research Research Quality Improvement
Sponsor: MGH Division of Clinical Research
Modules
| QI Roundtable: Source Documentation |
Past Offerings
| QI Roundtable: Source Documentation | Oct. 20, 2016 |
| QI Roundtable: Source Documentation | Oct. 26, 2017 |