GOOD CLINICAL PRACTICE (GCP) INSPECTIONS AMENDED FEES

Dear All,

Please provide your comments on the guideline to amend fees on GOOD CLINICAL PRACTICE (GCP) INSPECTIONS GCP inspections at clinical trial sites that will be payable per protocol and/or per activity.

Send your comments to: admin@sacraza.com by 15th April, 2021.

SAHPRA-GUIDE-TO-FEE-DETERMINATION-AND-PA

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8.1 GCP Local Inspections Local site inspections will attract a fee based on the activities performed at the site.

Hourly Rate Rationale R 1600 / h per inspector

Application of compensatory calculation for the hours involved in inspection and travel.

Example: 10 hours x 2 days = R32 000 for a GCP inspection.

Please provide your comments in the form below:

Comments form_SAHPRA FEE DETERMINATION A

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