| Service |
Rate Excluding VAT |
VAT 15% |
Rate Including VAT |
| Internal Review Non-Compliance |
R2,173.91 |
R326.09 |
R2,500.00 |
| New Clinical Trial Application (including Platform or Master Protocols) – Includes 5 sites with investigators |
R30,434.78 |
R4,565.22 |
R35,000.00 |
| More than 5 sites with initial application |
|
|
R200.00 per additional site |
| Device Trial Application |
R30,434.78 |
R4,565.22 |
R35,500.00 |
| Post Marketing Survey / Registry/ Observational Research / Epidemiological Research / Exploratory Research/ Non-Interventional Research / Environmental Research / Health and Social Care Services Research |
R21,739.13 |
R3,260.87 |
R25,000.00 |
| Complimentary Medicines/Cosmetics Research |
R21,739.13 |
R3,260.87 |
R25,000.00 |
| Data Analysis |
R13,043.48 |
R1,956.25 |
R15,000.00 |
| Genetics / Sub-Study |
R5,913.00 |
R886.96 |
R6,800.00 |
| Student Applications |
R8,695.65 |
R1,304.35 |
R10,000.00 |
| Major Amendment |
R13,043.48 |
R1,956.52 |
R15,000.00 |
| Minor Amendment |
R4,347.83 |
R652.17 |
R5,000.00 |
| Annual Re-Approval |
R10,869.00 |
R1,630.43 |
R12,500.00 |
| Sub-Protocol / Cohort to Platform Applications (per protocol/cohort) |
R1,739.13 |
R260.87 |
R2,000.00 |
| Additional Investigators after initial approval |
|
|
R250.00 per additional investigator |
| Amended Informed Consent Documents (non-administrative) |
R652.17 |
R97.83 |
R750.00 |
| Active Site Monitoring |
R1200 p/p, p/h to a maximum of 20 hours and 2 reviewers (VAT incl.)-- |
NDoH 2024 South African Ethics Guidelines training – Refer to the Pharma-Ethics website for more details
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
Please note:
•
Pharma-Ethics reserves the right to withhold approval letters and correspondence until payment is received.
•
Purchase Orders (where applicable) must be provided with the application.
•
Please quote protocol number/invoice number as reference on electronic payments and e-mail proof of payment to accounts@medpharm.co.za
•
Application forms must indicate VAT numbers and details of the company responsible for the account.
•
For account queries, please e-mail Ineke Vermeulen: accounts@medpharm.co.za
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