Study Maintenance

Shared Drive

\unch\dfs\rex\shared\Clinical Research\NCHV Research

☝️I would encourage you to browse through the folders, just be sure not to accidentally delete or move anything. This would be a good way to get an overview of our team's operations and what the moving pieces are.

In the Clinical Trials folder, there is a subfolder for every study, with the following sub-subfolders.

Billing Grid: Refer to when unsure a charge should be billed to the patient's insurance or the study

Correspondence: Where I save documents concerning SIVs, IMVs, COVs

SIV = Site Initiation Visit

IMV = Interim Monitoring Visit

COV = Close-Out Visit

Contracts: If Billing Grid does not help eludicate confusions re: billing, I sometimes look here for the CTA (clinical trial agreement). It shows that the sponsor agreed on paying when they contracted our site to run their study.

ICF: Where digital copies of the consent forms are stored

ICF = Informed Consent Form

IRB: Check here for which clinic locations are approved for the study, and when the approval starts/expires. You will need that information to set up monitoring visits.

Logs: Screening & Enrollment log (master sheet to keep track of visit windows/completions, and patient information), DOA log, device accountability log, site visit log. All the logs...

DOA = Delegation of Authority (some doctors will think it is Dead On Arrival, lol)

Protocol: Self explanatory.

Source Documents and Subject Materials: This is where the worksheets (CRFs), patient questionnaires, etc. lives. You can also save redacted patient documents, downloaded imaging, etc. here.

CRF = Case Report Form

Cathy has certain naming conventions for files. She does this to optimize her workflow and ensure consistency. When saving new documents (esp. scans of signed forms, etc.), do your best to follow those conventions.