Site Request Vs Parameters Question Preview (ID: 50976)
Linking Costs.
TEACHERS: click here for quick copy question ID numbers.
CTO Amendment Fee
a) IRB Amendment
b) Administrative Amendment Fee
c) IRB Renewal Fee
d) Protocol Review by Investigator
Outside Safety Letters
a) Administrative Amendment Fee
b) SAE Fee
c) IND Safety Letters
d) Archiving and Document Storage
Continuing Review Fees
a) IRB Initial Review
b) IRB Amendment Fee
c) IRB Renewal Fee
d) Site admin prep: IRB, ICF, amendment, etc.
Pharmacy monthly maintenance
a) Pharmacy Start Up
b) Pharmacy Annual Maintenance
c) Pharmacy Close Out
d) Pharmacy Storage Fees
File Storage
a) SAEs
b) IND Safety Letters
c) Archiving/Document Storage Fees
d) Site Admin Prep fee: IRB, ICF, Amendment, etc
eCRF training
a) Start Up Fee
b) Pharmacy Set Up
c) Laboratory Set Up
d) Training Site Personnel
Billing Compliance Fee
a) Medicare Coverage Analysis Fee
b) Site Admin Fee: IRB, ICF, amendments, etc
c) Site Audit Fee
d) Site Personnel Training
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
ICF Change with patient
a) Reconsent
b) Site Admin prep fee: IRB, ICF, amend, etc.
c) Re-screening
d) Informed Consent
Venipuncture
a) Central labs: Blood draw
b) Vital signs
c) ECHO
d) 12-lead ECG
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