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