SOP02V3 SOP for establishing and maintaining a TMF - Accord

ACCORD/ECTUSOP Number: ACCORD/ECTU/SOP02/3.0NHS Lothian and Version: 3.0The University of Edinburgh Effective Date: 27/10/2008• Blank AE/SAE/SUSAR forms (if not in protocol)• Reporting arrangements for SAE/SUSARs (if not already in theprotocol)• Copies of completed SAE/SUSAR forms• Copies of correspondence re SAE/SUSARs from Investigator toSponsor and/or Regulatory Authority• Copies of safety information sent to other Investigators (ifmulticentre trial)• Annual safety reports6 Research Team – Staff and Training• Signed/dated CV of Investigators, Sub-Investigators, Pharmacypersonnel• Delegation log• Signature sheet7 Monitoring and Audit• Risk assessment and monitoring plan• Monitoring reports• Monitoring correspondence (including telephone reports, followupletters etc)• Audit certificate• Clinical trial report8 Investigational Medicinal Product (IMP)• Investigator Brochure (IB) and/or Summary of ProductCharacteristicsLaboratories• Accreditation of all labs used (and updates)• Normal value references for all labs used (and updates)Case Report Forms• Sample copy of CRF (and any previous versions) if not already inthe protocol• Completed CRFs and any corrections• Record of biological samples taken9 Pharmacy (can be stored in pharmacy)• Certificate of analysis of investigational product(s) shipped• Sample labels• Instructions for handling the IMP (if not already in the IB orSmPC)• Drug delivery/return records• IMP accountability logs• Documentation of IMP destruction10 General correspondenceOtherControlled Document – Do Not CopyPage 6 of 8