Policy
Maintenance of Human Subject Research Regulatory Documentation, Policy #
GR042
Where can you find Northwell guidance for maintaining a regulatory binder?
HRPP website
Can you keep signed consent forms in the regulatory binder?
Yes
You received communication from your monitor that a new monitor is taking over the trial. Do you file this communication in the regulatory binder? Explain.
Yes, in the sponsor correspondence section.
ex: newsletters
What is the purpose of a regulatory binder
Central respository for all documents pertaining to a specific study to ensure compliance
"Credentials" is a required section of the regulatory binder. Explain our process.
Memo note
Florence Credentials
Can you maintain PHI in a regulatory binder? Explain.
Yes,
Subject Identification Log
Screening & Enrollment Log
Signed Consent Forms
A new protocol revision was recently approved. What do you do with the new and old revisions?
File the new revision and make sure to keep the old.
Who is responsible for the maintenance of the regulatory binder?
Investigator and/or study coordinator
We are a satellite site for a study. Do we maintain the regulatory binder for the study?
No
How and where do you store research data collected as part of your protocol?
What is IRB-approved data repository or EDC?
CIRB used for a study, permission to cede is received from Northwell IRB, do we maintain the Northwell IRB section of the regulatory binder? Explain.
Yes
Can the regulatory binder be electronic? Explain.
Yes,
Northwell approved secure platform.
Electronic system is maintained securely and documents filed and organized in a fashion that is readily retrievable and available for inspection.
What kind of trials require a pharmacy binder? Where is this kept? Electronic, paper, or both?
Drug, Research Pharmacist, Paper
What is the difference between a regulatory binder and trial master file (TMF)?
Regulatory binder specific to a single site's documents
TMF - all documents across all sites for a specific study.
Where should you file internal audit reports?
Not in the study's regulatory binder; our process - SharePoint
How long should research records be retained for?
45 CFR 46 - at least 3 years after the completion of the research
Refer to specific study protocol
Policy 100.97 Records Retention and Destruction
What is the difference between a continuing review and progress report?
Trick Question - No difference
When we are site selected.
Lead site keeps originals
Mail out originals, tracking #, etc.