Unit Operations
Documentation
Study Management
Quality Assurance
Potpourri
100
You should do this every time you enter or exit an exam room.
What is wash/disinfect your hands or gel-in, gel-out?
100
Hospital system used to log research subject visits and study procedures
What is eTrac?
100
Length of time you have to report an SAE to the NCH IRB.
What is 72 hours?
100
The mandatory unit process that promotes and monitors the quality control for all visits involving informed consent.
What is the peer review process?
100
Type of services/procedures that are not billed to research.
What is standard of care services/procedures?
200
This is the minimum number of study staff required on the unit to conduct a study visit
What is 2?
200
This document lists staff members for a study and what procedures they can perform
What is the Delegation of Authority Log?
200
The log that must be sent with archived records.
What is the recruitment log?
200
All stored samples must have at least these 2 identifiers on them.
What are subject study ID and subject initials?
200
What is the proper way to document study training?
What is a Study Training Log?
300
All received electronic equipment for a research study must be signed into service by this department.
What is Biomedical Services?
300
This may a require a re-consent/assent of the study subject.
What is protocol amendment?
300
Data regarding an AE/SAE may be collected by any study team member, but the PI is the only team member that can assess these three qualities.
What is severity, causality and seriousness?
300
The name of the CRS Medical Director.
Who is Preeti Jaggi, MD?
300
Person you call when you are late or ill.
What is your Team Leader and front desk? (also Director if Admin)
400
The number attempts that can be made at a venipuncture.
What is three?
400
The suggested window for obtaining a PI's signature on lab reports with no "out of range" values.
What is 2-3 business days.
400
This should be collected for all protocol amendments from staff personnel list on the DOA.
What is Proof of Training/Proof of Acknowledgement?
400
For all medication studies, the Inclusion/Exclusion criteria must be checked by Compliance prior to this visit.
What is the randomization visit?
400
All specimens will be tracked on this when put into the freezer and when removed.
What is the Specimen Tracking Log?
500
This is not an acceptable final form of communication regarding study specific information.
What is verbal communication?
500
A single line with date & initials.
What is the approved correction method?
500
This should be checked on all study supplies before use.
What is the expiration date?
500
The two metrics that may be tied to performance evaluations.
What is error rate of consents, and number of preventable protocol deviations/violations.
500
This is not allowed in clinical areas or labs.
What are open-toed shoes?
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