Section 8: Investigational Medicinal Product (IMP) 8.1 Current IB or SmPC for each IMP and non-IMP used in the trial and superseded versions Investigator Brochure (IB) / Summary of Product Characteristics (SmPC) 8.2 Current approved Reference Safety Information and superseded versions (refer to 8.1 as Reference Safety necessary) Information 8.3 used for the trial IMP(s) IMP label(s) 8.4 Prescription temp Prescription template 8.5 Certificate of analysis (batch release certificate) issued by the Qualified Person (QP) for each QP release batch of the trial IMP(s) throughout the trial 8.6 Study specific pharmacy procedures and guidance, including risk assessments and pharmacy Handling and storage manuals for sites of IMP Contact details for IMP manufacturer and/or distributor 8.7 IMP storage temperature records Monitoring and Quality QP reports and assessments Stability data SASR listings 8.8 Documentation and correspondence relating to unblinding of participants Records of unblinding
Section 8: Investigational Medicinal Product (IMP) 8.1 Investigator Brochure (IB) / Summary of Product Characteristics (SmPC) Current IB or SmPC for each IMP and non-IMP used in the trial and superseded versions 8.2 Reference Safety Information Current approved Reference Safety Information and superseded versions (refer to 8.1 as necessary) 8.3 IMP label(s) used for the trial IMP(s) 8.4 Prescription template Prescription temp 8.5 QP release Certificate of analysis (batch release certificate) issued by the Qualified Person (QP) for each batch of the trial IMP(s) throughout the trial 8.6 Handling and storage of IMP Study specific pharmacy procedures and guidance, including risk assessments and pharmacy manuals for sites Contact details for IMP manufacturer and/or distributor 8.7 Monitoring and Quality IMP storage temperature records QP reports and assessments Stability data SASR listings 8.8 Records of unblinding Documentation and correspondence relating to unblinding of participants
tmpl_043_ctimp_trial_master_file_contents_index_v2.0_09.04.18.docx