Regulatory Binder Trivia

Policy

100

Maintenance of Human Subject Research Regulatory Documentation, Policy #

GR042

200

What is the purpose of a regulatory binder

Central respository for all documents pertaining to a specific study to ensure compliance

300

Who is responsible for the maintenance of the regulatory binder?

Investigator and/or study coordinator

400

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.

500

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

Maintenance (1)

100

Where can you find Northwell guidance for maintaining a regulatory binder?

HRPP website

200

"Credentials" is a required section of the regulatory binder. Explain our process.

Memo note

Florence Credentials

300

We are a satellite site for a study. Do we maintain the regulatory binder for the study?

No

400

What kind of trials require a pharmacy binder? Where is this kept? Electronic, paper, or both?

Drug, Research Pharmacist, Paper

500

What is the difference between a continuing review and progress report?

Trick Question - No difference

Maintenance (2)

100

Can you keep signed consent forms in the regulatory binder?

Yes

200

Can you maintain PHI in a regulatory binder? Explain.

Yes,

Subject Identification Log

Screening & Enrollment Log

Signed Consent Forms

300

How and where do you store research data collected as part of your protocol?

What is IRB-approved data repository or EDC?

400

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.

500

At what point of the study start up do you create your Florence regulatory binder?

When we are site selected.

Scenarios

100

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

200

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.

300

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

400

Where should you file internal audit reports?

Not in the study's regulatory binder; our process - SharePoint

500

A study is being conducted across 8 Northwell sites. Sponsor requires paper DOA. Explain the GCP for DOA entries/completion.

Lead site keeps originals

Mail out originals, tracking #, etc.