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The Division of Clinical Research at Massachusetts General Hospital provides a variety of resources to help clinical investigators properly document their study data.
The Partners Quality Improvement (QI) Program's Regulatory Binder is an excellent tool to support you in properly organizing your regulatory documentation. Be sure to keep paper and electronic copies of all Institutional Review Board (IRB) related documents. To access the Partners QI Program Electronic Regulatory Binder for an IRB approved protocol: login to REDCap with your Partners username and password, click the tab titled “Request New Project” and complete the fields for requesting the Electronic Regulatory Binder template.
As it is often unpredictable when your project will be audited, it is best to manage your project’s documentation as if you might be monitored or inspected at any time.
Have all regulatory and subject-related information properly documented, and remember that documentation plays a crucial role in validating your work during monitoring or inspection.
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