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SAHPRA Requirements for Clinical Trials and Investigations

Regulation 16 of the Regulations Relating to Medical Devices deals with the Conduct of Clinical Trial and Clinical Investigations.

The Following documents related to Clinical Trials

2.11_Safety_Reporting_Clinical_Trial_Nov19_v3-1
2.41_Emergency_Procedures_Clinical_Trial_Sites_Jun16_v2_showing_changes-1
2.41_Emergency_Procedures_Clinical_Trial_Sites_Jun16_v2-1
2.42_Post_Clinical_Trial_Access_Apr19_v2-1
2.43_Oversight_Monitoring_Clinical_Trials_Sept16_v1-1
2.47_Clinical_Trial_Investigators_Apr17_v2_showing_changes-1
2.49_Capacity_Building_Clinical_Trials_Nov_17_v1_for_comment-1
2.51_CT_TIE_Compensation_Model_May18_v1-1
2.53_Investigator_Workload_Clinical_Trials_July19_v1-1
2.55_LiabilityInsuranceforClinicalTrials_Nov2019_V1-1
6.05_CTF1_May19_v4-1
6.15_Screening_template_SA_Jun14_v8_showing_changes-1
6.20_PRC_Checklist_Jun14_v1-1
6.24_Notification_template_Phase_IV_Apr17_v1-1
6.27_CT_Six_monthly_progress_report_form_May_18_v2-1
6.29_Procedure_ConsultationMeetings_ClinicalTrialApplicants_Nov19-1
6.37_Safety_Reporting_Form_Clinical_Trials_Nov19_v2-1
9.53_CTC_dates_2020_v1_1-1
9.59_Electronic_submission_clinical_trials_Apr19_v2-1
9.84_Clinical_Trial_Investigators_Apr17_v2-1
Regulations-relating-to-Medical-Devices-and-IVDs-20161209-1
SA_GCP_guidelines_second_edition_2006-1
StrategicFrameworkforCommunication-FINAL-1Nov2019-1
Type-II-DeepDiveSurvey-FAQ22August-1

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