Adverse Event reporting: decide on Protocol UoB-CLN-AES-SOP-001 processes surrounding classification, communication pathways for reporting and trend analysis. Identify trial specific reference safety Investigator UoB-CLN-ESD-SOP-001 information and establish process for Brochure/SmPC/Reference monitoring updates to the reference Safety Information safety information for the duration of the trial. Research laboratory (if involved in Laboratory manual UoB-CLN-LAB-SOP-001 primary/secondary endpoint analysis):, set up laboratory in line with GCP in the Lab standards Personal data (where collected): set Protocol, Information Sheet/ up processes for data collection, Consent Form handling, storage and destruction in line with the Data Protection Act.
Adverse Event reporting: decide on processes surrounding classification, communication pathways for reporting and trend analysis. Protocol UoB-CLN-AES-SOP-001 Identify trial specific reference safety information and establish process for monitoring updates to the reference safety information for the duration of the trial. Investigator Brochure/SmPC/Reference Safety Information UoB-CLN-ESD-SOP-001 Research laboratory (if involved in primary/secondary endpoint analysis):, set up laboratory in line with GCP in the Lab standards Laboratory manual UoB-CLN-LAB-SOP-001 Personal data (where collected): set up processes for data collection, handling, storage and destruction in line with the Data Protection Act. Protocol, Information Sheet/ Consent Form