eTMF Basics
Lewis & Clark
Quality is Job 1
Spells & Pointed Hats
HodgePodge
100
The three C's are Complete, Consistent and ______?
What is compliant?
100
The number of review cycles required per SOP.
What is Two reviews?
100
The purpose of conducting periodic TMF reviews.
What is Inspection Readiness?
100
The owner of the ISF tracker.
Who is the CRA?
100
Internal documents that provide "how to" guidance, but are not SOPs.
What is a Work Guideline?
200
TMF organization hierarchy: study -> ______ -> site
What is country?
200
They are not plain vanilla by any means, this is where Sites and CRAs will send all requested documents.
What is the study mailbox?
200
The process of selecting someone else to perform a QC task.
What is Delegate?
200
Project Leadership will discuss performance issues that have been escalated with this person.
Who is the Line Manager?
200
The number of phases in the Precision project life-cycle.
What is 5 project life-cycle phases.
300
Document used at Precision to document and list all of the unused folders in the TMF for a particular study.
What is a Note to File?
300

Documents should be submitted during or within X number of business days from the time of the visit.

What is 5 business days?
300
During start-up, the trial team will create a plan for file reconciliation and document the plan in this project document.
What is a Document Management Plan?
300

A (blank) sets the expectations and drives the plan for file reviews and ensures accountability to the agreed upon timelines.

Who is the Project Manager?
300
The name of the process for site activation.
What is Green Light?
400

ICH (2016) E6 (R2) Revision that describes 'Essential Documents for the Conduct of a Clinical Trial'.

What is ICH E6 R2 section 8?
400
CRAs use this tool when submitting documents.
What is the TMF document transmittal form?
400
All documentation issues should be resolved within X number of days.
What is 30 calendar days?
400
Other than the  Protocol name/number, document identifier, date, and version of a document, what other "ingredient" is needed in the standard nomenclature when naming a document.
What is the Site Name/Number?
400
This type of project document is always required or it can be the inside of an apple.
What is core?
500
Sure Clinical preferred TMF reference model.
What is the Oasis reference model?
500
Time frame in which documents submitted/collected should be uploaded and available to view in the eTMF?
What is 15 business days?
500
Select this if all content and metadata pass all QC checks.
What is Finalize?
500
This is the TMF repository of questions where questions can be maintained and can be edited.
What is Sure Clinical FAQ spreadsheet?
500
This tool is used during monitoring trip report authorship and reviews to ensure the development and finalization of a quality report.
What is a completion guideline?
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