| |
RATE EXCLUDING VAT |
VAT 15% |
RATE INCLUDING VAT |
Internal Review Non-Compliance |
R2,173.91 |
R 326.09 |
R 2 500.00 |
New Clinical Trial Application (including Platform or Master Protocols) – Includes 5 sites with their investigators |
R27 391.30 |
R 4 108.70 |
R31 500.00 |
> 5 sites with initial application |
R 100.00 per additional site |
Device Trial Application |
R27 391.30 |
R 4 108.70 |
R31 500.00 |
Post Marketing Survey / Registry/ Observational Research / Epidemiological Research / Exploratory Research/ Non-Interventional Research / Environmental Research / Health and Social Care Services Research |
R18 695.65 |
R 2 804.35 |
R21 500.00 |
Complimentary Medicines/Cosmetics Research |
R18 695.65 |
R 2 804.35 |
R21 500.00 |
Data Analysis |
R13 043.48 |
R 956.25 |
R15 000.00 |
Genetics / Sub-Study |
R 5 217.39 |
R 782.61 |
R 6 000.00 |
Student Applications |
R 8 695.65 |
R 1 304.35 |
R 10 000.00 |
Major Amendment |
R 11 739.13 |
R1 760.87 |
R13 500.00 |
Minor Amendment |
R 3 913.04 |
R 586.96 |
R 4 500.00 |
Annual Re-Approval |
R10 000.00 |
R 1 500.00 |
R11 500.00 |
Sub-Protocol / Cohort to Platform Applications (per protocol/cohort) |
R 695.65 |
R 104.35 |
R 800.00 |
Additional Investigators after initial approval |
R 100 per additional investigator |
Amended Informed Consent Documents (non-administrative) |
R 434.78 |
R 65.22 |
R 500.00 |
Active Site Monitoring |
R1000 p/p, p/h to a maximum of 20 hours. |
Please note:
•
Pharma-Ethics reserves the right to delay feedback on submissions that do not meet the submission requirements
•
Included with the initial application fee: Processing and reviewing of Adverse Drug Reactions, Progress Reports, Safety Reports, General Correspondence, Passive Monitoring
•
An administrative fee of R 50.00 will be charged for re-sending documents.
•
Withdrawal of applications after submission but before meetings will be charged for costs incurred and a 10 % handling fee.
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