Audit Readiness
This must be obtained before performing ANY study-specific procedures on a subject.
What is informed consent.
This is the best way to find out if patient travel is arranged through CTR/Lyft or a third-party vendor?
What is checking the Subject Receipt Reimbursement Tracker?
The person who completes the DOA.
Who is the Lead CRC
This should be completed prior to a visit occurring.
What is visit prep?
This should include review source, supplies (this includes lab kits/vaccines, etc.), required system access, review IRB for current ICF versions, review open AE/SAE's, review schedule of activities and ensure you are up to date on any protocol amendments.
This is when it is acceptable to NOT enter data in both CTMS and EDC.
What is NEVER, data should always match
If this is missing or outdated, it raises concerns about whether staff were authorized and trained to perform study tasks.
What is the delegation of authority log?
This is the best way to determine whether a patient stipend will be paid via RT Pay or a third-party vendor.
What is reviewing the ICF?
These critical items must be completed before a Site Initiation Visit can occur, ensuring the site is fully ready to begin the study.
What is everything needed prior to SIV, including portal access granted, study supplies received, budgets and contracts finalized, and patients identified?
When notified of a protocol amendment, these teams should be made aware.
Who is: Source Build Team
Budgets and Contracts
Start-up (for vendor management)
An unscheduled visit should always have this within RT to explain and document why an unscheduled visit was completed.
What is a note.
This is essential for a clear understanding as to why an USV was needed in the event this needs to be communicated with the sponsor.
This form is completed if notified of an FDA Audit
AD RA 005 Audit-Inspection Call Checklist (this should be printed and should be at every desk) follow the instructions - notify PI, Site Ops, Quality
AND AD QA 002 Auditor Notification Form
This is completed and sent to Quality
True or False: A subject attends a scheduled visit. During the visit, an unscheduled procedure is completed and documented as an unscheduled visit in RT and EDC. It is acceptable to pay the patient two stipends—one for the scheduled visit and one for the unscheduled procedure.
What is False
(The patient is most likely reimbursed only for the scheduled visit; the ICF must be reviewed to confirm.)
This tracker contains subject reimbursement details
What is the Subject Reimbursement Tracker?
*If your study is not listed, please notify Cassidy
This is the timeline for source completion to QC.
What is 48 hours.
Upon completion of a visit, data should be entered in this time frame.
What is as soon possible, but no more than 3 days.
This must clearly demonstrate the investigator’s assessment of seriousness, causality, and expectedness for each SAE.
What is the SAE report or safety report documentation?
True or False: A patient completes a screening visit in mid-February and is later determined to be a screen fail. Because the patient did not randomize, there is no need to assign a screening number in RT.
What is False?
(Screening numbers are required for CTR to receive payment and must be entered even during screening.)
This person is the point of escalation if needed when the site has not received the accesses or supplies required.
Who is Taylor Martin or Brandi Chalman
This common QC error occurs when data is entered without sufficient detail to support the study endpoint or visit requirement.
What is inadequate or incomplete source documentation.
This is the impact data entry has in RT.
What is a financial impact.
If something is not clear regarding data entry, please reach out for support.
This recurring issue—when visit windows are missed without documentation or justification—often leads to audit findings and CAPA.
What is unreported or poorly documented protocol deviations?
These are the steps to take when you have a patient is on site for a 5-hour visit, purchases their own meal, and requests reimbursement. You’ve confirmed reimbursement is allowed.
What is emailing Finance with the patient receipt and including the protocol, screening number, visit name, and visit date to request reimbursement?
This person is responsible for start-up documents requested, including SDA, Blinding plan, updating Site Contact List, etc.?
Who is Lead CRC
These things are what make up an SAE.
Death, Hospitalization, Congenital abnormality or Birth defect, Life Threatening, Persistent or Significant Disability
This is the timeline for entering the patient's enrollment status.
What is as soon as it is known.
The status may impact how we bill the sponsor.