Site Request Vs Parameters Question Preview (ID: 50976)


Linking Costs. TEACHERS: click here for quick copy question ID numbers.

Venipuncture
a) Central labs: Blood draw
b) Vital signs
c) ECHO
d) 12-lead ECG

ICF Change with patient
a) Reconsent
b) Site Admin prep fee: IRB, ICF, amend, etc.
c) Re-screening
d) Informed Consent

FDA Audit Fee
a) Site Audit-Not for Cause
b) Site Audit-For Cause
c) Protocol Review: Study coordinator
d) Site Admin Fee: IRB, ICF, amends, etc

Billing Compliance Fee
a) Medicare Coverage Analysis Fee
b) Site Admin Fee: IRB, ICF, amendments, etc
c) Site Audit Fee
d) Site Personnel Training

eCRF training
a) Start Up Fee
b) Pharmacy Set Up
c) Laboratory Set Up
d) Training Site Personnel

File Storage
a) SAEs
b) IND Safety Letters
c) Archiving/Document Storage Fees
d) Site Admin Prep fee: IRB, ICF, Amendment, etc

Pharmacy monthly maintenance
a) Pharmacy Start Up
b) Pharmacy Annual Maintenance
c) Pharmacy Close Out
d) Pharmacy Storage Fees

Continuing Review Fees
a) IRB Initial Review
b) IRB Amendment Fee
c) IRB Renewal Fee
d) Site admin prep: IRB, ICF, amendment, etc.

Outside Safety Letters
a) Administrative Amendment Fee
b) SAE Fee
c) IND Safety Letters
d) Archiving and Document Storage

CTO Amendment Fee
a) IRB Amendment
b) Administrative Amendment Fee
c) IRB Renewal Fee
d) Protocol Review by Investigator

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