Data Control
TRUE OR FALSE: Per the GeriOnc Data Control Workflow, all paper source documents can be corrected in any color ink or pencil, if preferred.
FALSE
You must de-identify above this age
During SSU, you do not need to register within this system if you are not consenting subjects
OnCore
We are on version V.? of the GeriOnc Project Tracker.
V8.0
TRUE OR FALSE: When a study closes to accrual and all study activities are complete, the research charts stay at WCI.
FALSE
Answer: They are immediately moved to SRB.
TRUE OR FALSE: Data Control is the only team who can edit a subject survey in REDCap
FALSE
The PI, the PM, or a member of the data control team can edit a survey.
When using the Research tab in eRecord, "red" means this
Charges covered under SOC
When a study closes to accrual, you submit this update to this regulatory authority
TRUE OR FALSE: While completing a staff change, the research coordinator should always submit an EDC request to the data control team.
FALSE
Reason: We do not submit a central request for studies that (1) we are a subsite for and (2) do not have an EDC
TRUE OR FALSE: Per the GeriOnc CCPL Workflow, all laboratory staff are required to be listed on the study DAL.
FALSE
Answer: Only the CCPL Director needs to be IRB-approved and officially delegated.
TRUE OR FALSE: CSFs should only be completed and followed-up on during the protocol window
TRUE
TRUE OR FALSE: If a subject consents, but is not considered enrolled onto the study yet, you only tag them as a "CONSENTED" in OnCore.
TRUE
Reason: Adding an on-study date is not only incorrect, but it will throw off the total # of accruals.
If DT4 applicable, GeriOnc should activate the study this amount of days after SUBMITTING to WCI PRMC
90 days
When a staff member leaves GeriOnc, you should update this
Their staff profile
Per the GeriOnc Wilmot 2nd Floor Lab & Infusion Blood Sample Workflow, what is the first thing the research coordinator should do?
Confirm if the blood draw is peripheral or port.
TRUE OR FALSE: All measures requiring pre-approval or licensing can be acquired after IRB-approval
FALSE
How soon do you report a qualifying SAE to Wilmot DSMC?
10 calendar days
This committee will review and acknowledge research being conducted at Highland Hospital
Administrative Research Review Committee (ARRC)
A PI has a new study funded by the NCI. The research coordinator should use this DSF template
GeriOnc DSF: External Sponsor Template
TRUE OR FALSE: You register every study on ClinicalTrials.gov
FALSE
You only register (1) ACT's and/or (2) studies required to be registered per the grant/contract/sponsor
T7 of the maintenance EDC workflow states that changes that will impact data analysis should be reviewed by this individual BEFORE IRB submission
The study statistician
WCI pulls these two metrics monthly from OnCore
Race & Ethnity
If using a short form, the study team is required to submit for full translations within this amount of days
60 days
When receiving a CR reminder from RSRB, GeriOnc process is to submit the CR no later than...
45 days prior to expiration
Per SOPA2.1, the interpreter signs here during the consent process.
The white space of the consent form