Version Document Title CI PI TM RN Stat Dat Pha Lab Initial number SOP-QA-17 Project committees SOP-QA-18 Randomisation and blinding for controlled trials SOP-QA-19 Amendments SOP-QA-20 Data management for clinical trials SOP-QA-21 APRs and DSURs SOP-QA-22 Adverse Event in CTIMPs SOP-QA-23 Statistical analysis plans for clinical trials SOP-QA-24 Managing a change in CI of a CTIMP or Device Trial SOP-QA-25 Deviations and Breaches SOP-QA-26 Sponsor file SOP-QA-27 Good documentation practice SOP-QA-28 Monitoring SOP-QA-29 Audit SOP-QA-30 MHRA inspection SOP-QA-31 Research project closure SOP-QA-32 Archiving SOP-QA-33 Research project publications and dissemination SOP-QA-34 GCP training SOP-QA-35 Unblinding SOP-QA-36 Retention of health records of clinical trial patients SOP-QA-37 Management review SOP-QA-38 Equipment Adverse Events in Medical Device Clinical Investigations SOP-QA-39 SOP-QA-40 Multi-centre site selection CI Chief Investigator PI Principal Investigator TM Trial Manager RN Research Nurse/Researcher – – – – Stat Statistician Dat Data Programmer/analyst Pha Pharmacist Lab Laboratory – – – –
Document Title CI PI TM RN Stat Dat Pha Lab Initial Version number SOP-QA-17 Project committees SOP-QA-18 Randomisation and blinding for controlled trials SOP-QA-19 Amendments SOP-QA-20 Data management for clinical trials SOP-QA-21 APRs and DSURs SOP-QA-22 Adverse Event in CTIMPs SOP-QA-23 Statistical analysis plans for clinical trials SOP-QA-24 Managing a change in CI of a CTIMP or Device Trial SOP-QA-25 Deviations and Breaches SOP-QA-26 Sponsor file SOP-QA-27 Good documentation practice SOP-QA-28 Monitoring SOP-QA-29 Audit SOP-QA-30 MHRA inspection SOP-QA-31 Research project closure SOP-QA-32 Archiving SOP-QA-33 Research project publications and dissemination SOP-QA-34 GCP training SOP-QA-35 Unblinding SOP-QA-36 Retention of health records of clinical trial patients SOP-QA-37 Management review SOP-QA-38 Equipment SOP-QA-39 Adverse Events in Medical Device Clinical Investigations SOP-QA-40 Multi-centre site selection CI – Chief Investigator PI – Principal Investigator TM – Trial Manager RN – Research Nurse/Researcher Stat – Statistician Dat – Data Programmer/analyst Pha – Pharmacist Lab – Laboratory