eTMF Treasure Hunt
This document tells you where nearly every study document lives in the eTMF.
What is the "eTMF Document Guidance"? (country level folder 01.01.02)
QC cannot occur until you've completed this step after uploading a document.
What is document classification?
Coordinators, pharmacists, and regulatory staff all use this personnel designation in their uploaded reg doc file names.
What is "Other Study Team"?
This document shows who was authorized to perform study activities and when those responsibilities began.
What is the Delegation of Authority (DOA) Log?
For the most current IRB-approved informed consent form, sites should obtain documents from this system rather than downloading them from the eTMF.
What is the Advarra Portal?
Every document uploaded to the eTMF should begin with this study identifier and site information.
What is "APT-TBI-01_Site Name"?
When naming personnel documents, names should appear in this format.
What is "Last_First"?
A well-maintained eTMF supports this state of readiness, allowing a site or sponsor to withstand an audit or inspection at any time.
What is inspection readiness?
A coordinator needs instructions for processing and shipping biospecimens but can't remember the procedure. This document contains those instructions.
What is the "Biospecimens Procedures" manual? (country level 08.01.05)
Every document uploaded to the eTMF should end with this information.
What is the document date? (MM-DD-YYYY format)
These are the only three personnel titles recognized within the eTMF.
What are PI, Sub-I, and Other Study Team?
A complete eTMF helps demonstrate compliance with this three-letter quality standard.
What is GCP?
This document contains the current study contacts for all sites/relevant study teams for APT-TBI-01.
What is the "Study Point of Contact Document"? (country folder 01.02.01)
Every document signed electronically must adhere to this federal regulation.
What is 21 CFR Part 11 compliance? (confirm this applies to whichever electronic system you use)
A document is created on June 1st, signed on June 5th, and uploaded on June 10th. This date should appear at the end of the file name.
What is June 5th?
Together, the documents in the eTMF help demonstrate compliance with regulations, protection of participants, and integrity of this.
What is the study/clinical trial/data?
This document provides detailed instructions for conducting study activities and is frequently referenced throughout the trial.
What is the "Manual of Procedures"? (country folder 01.01.05)
This signature/date combination is not acceptable for study documents.
What is a wet-ink signature paired with an electronic date (or vice versa)?
This date belongs in the filename, even if the document is uploaded days or weeks later.
What is the document creation, signature, or training completion date? (Latest date on the doc is the date you put in the file name)
A complete eTMF should allow an independent reviewer with no prior involvement in the study to do this.
What is reconstruct the conduct of the trial?