What piece of documentation accompanies Bio-specimens during shipping?
Shipping manifest
100
What age does the patient need to be to sign assent?
7 years old or older
100
What was the name of the Stanfords' pet cat whose name lives on in a popular local restaurant?
Tootsie
100
What kind of status must an investigator have in order to sign PMB designated chemotherapy orders?
Active CTEP status
100
Stanford’s Free Marguerite Shuttle Service is named after Jane Stanford’s favorite ____?
Horse
200
What is the audit Bible for auditors?
Audit Guide
200
What needs to happen when a patient turns 18 while on study?
Re-consent with the age of majority consent or adult consent.
200
Where do source documents need to be for audit review?
In the patient’s study binder
200
What 4 forms do you submit for annual NCI investigator status renewal?
Renewal or supplemental form, financial disclosures, CV, 1572
200
Who absolutely must sign off on eligibility before registration can occur per GCP?
Treating physician/PI
300
What kind of finding is it if a safety lab test is missed?
Major
300
What form documentation is needed to validate LAR status?
Notarized legal document
300
What needs to accompany the Consent Form?
Documentation of the Informed Consent Process
300
What is a DARF and what is it used for?
Drug Accountability Record Form, pharmacist drug inventory
300
Who else needs to sign off on eligibility before registration can occur per Stanford University?
CRC and 3rd signature
400
What kind of finding is it to not report an SAE per protocol guidelines?
Major
400
What do you do when the sponsor adds a new safety lab test?
Re-consent all affected patients
400
What are the four major sections in the patient binder?
Consent, Eligibility, Treatment, Follow Up
400
Who can order investigational product from PMB?
The PI or a PI designee (this can be CRC)
400
What is not granted under any circumstances for Cooperative Group Studies Study Eligibility?
Eligibility Waiver
500
Within how many weeks after patient enrollment do we need to submit tissue for most studies?
4 weeks
500
Which three dates do you verify on the consent document before consenting?
Approval, expiration and version date
500
What do we print from OPEN?
Enrollment documentation
500
Where is the drug shipped?
To the IDS that is listed on the PIs CTEP Documents
500
How do Cooperative Groups call any woman who has not undergone hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 12 consecutive months?