Study Site File SOP - Liverpool School of Tropical Medicine

FINALSTANDARD OPERATING PROCEDURE:STUDY SITE FILE SET UP AND MAINTENANCESOP number CTS SOP 006 Effective Date: 01.11.10Version number: 1.0 Approved by: N StricklandSuperseded Version Number & Date: Review Date: 01.11.11Originator S Roberts Status: Final1.0 PURPOSETrials involve a large amount of document for which a standard system of filing is required.Documentation at each study site should be contained within a Study Site File (SSF) which should beset up as the Site is initiated into the study. It supplements the Trial Master File which is held at theCo-ordinating centre of the trial.ICH Good Clinical Practice guidelines define the study documents to be filed as “those documentswhich individually and collectively permit evaluation of the conduct of a trial and the quality of thedata produced”. Whilst demonstrating compliance with ICH Good Clinical Practice, the filing of studydocuments in an orderly, timely manner also greatly assists the smooth running of the study and anyfuture audit or inspection.The use of these procedures will result in a standardised method for collating and maintainingrelevant documentation.2.0 PROCEDUREThe Study Site File (SSF) should be located in a secure (locked) designated area at the Study Site.A template for the setting out of the SSF is appended to these procedures in Appendix A.The SSF should be divided into sections, numbered according to the list attached.At the start of each section, a checklist of each document contained therein should be maintained.Within each section, each document added to the File should include a note of the date it was added,in the top right hand corner of the front sheet of the copy.2.1 WHO?The Local Investigator and/or other designee(s) as documented in the Trial Responsibility Log mustensure that the Study Site File is established and properly maintained at the co-ordinating centre.2.2 WHEN?The Study Site File should be prepared as soon as possible as soon as the site is initiated into thestudy. The file should be actively maintained and updated from this time until the trial is formallyclosed. When it becomes available, the final report should be filed in the trial master file.CTS SOP 006: Site Study File Page 1 of 3Version: 1.0Status: FINALRelease date: 01/11/10

FINAL2.3 HOW?This SOP refers to the current minimum standard of documentation required in the Study Site File, asoutlined in ICH GCP; Section 8.2, 8.3 and 8.4.3.0 RELATED DOCUMENTSLSTM CTS TF 005: Trial Master FileLSTM CTS SOP 003: Trial Master FileLSTM Policy: The Archiving of Essential Documents Generated during Clinical Research.4.0 REFERENCESInternational Conference of Harmonisation Good Clinical Practice (ICH GCP) 19965.0 FURTHER INFORMATIONPlease contact the Research Office for further support and guidance.6.0 APPENDICESAppendix A - Template for Study Site FileCTS SOP 006: Site Study File Page 2 of 3Version: 1.0Status: FINALRelease date: 01/11/10

FINALAPPENDIX ATEMPLATE STUDY SITE FILESECTION 1 TRIAL SPECIFIC DOCUMENTATIONProtocol, including version number, signed and datedPrevious version of protocolInformation given to trial participants - Informed consent form (including all applicabletranslations)Completed Informed Consent LogCopy of patient/subject information leaflet/sheetPrevious versions of patient information leaflet(s)/sheet(s)SECTION 2 RESEARCH ETHICS COMMITTEE APPROVALCopy of ethics committee application and approval for study site(s)SECTION 3 SCREENING AND RECRUITMENT RECORDScreening and enrolment log – documenting the number of subjects enrolledCopies of signed and dated informed consent forms from all subjectsSECTION 4 RESEARCH & TRIAL PERSONNELName and signature log for all personnel involved in the conduct of the trialSigned and dated CV’s for all site staffTask delegation logSECTION 5 TRIAL SAFETY PROCEDURESUnblinding procedure for blinded trialsBlank AE/SAE/SUSAR recording and reporting formsCopies of completed AE/SAE/SUSAR report formsSECTION 6 FUNDING INFORMATIONCopy of funding arrangementsSECTION 7 CASE REPORT FORMS (CRF’S) DATA COLLECTIONSample copy of CRF/data collection form to be used, detailing version numberCopies of all previous version of CRF’s/data collection formsSECTION 8 TRIAL MONITORING/AUDIT/INSPECTIONMonitoring visit reportsAudit/inspection reportsSECTION 9 LABORATORIESAccreditation certificates of all laboratories usedNormal value references for all laboratories usedAny other reference information relating to laboratories used for the trialSECTION 10 GENERAL CORRESPONDENCECopies of all other correspondence relating to the trialRecords of all other significant telephone conversations relating to the trialCTS SOP 006: Site Study File Page 3 of 3Version: 1.0Status: FINALRelease date: 01/11/10