Clinical study report preparation - Accord - University of Edinburgh

ACCORDNHS Lothian R&D andThe University of EdinburghSOP Number: CR011v1.0Effective Date: 22/MAR/2011CLINICAL STUDY REPORT PREPARATION - CTIMPsSOP NUMBER:CR011VERSION NUMBER: 1.0EFFECTIVE DATE:RELEASE DATE:22/March/201124/February/2011SignatureSignature kept on fileDate24/Feb/2011AUTHOR: Dawn Lyster, QA Officer, ACCORD/University of EdinburghSignature kept on file24/Feb/2011APPROVED BY (1): Louisa Wilson, Senior Clinical Trials Monitor,ACCORDSignature kept on file24/Feb/2011APPROVED BY (2): Paul Dearie, QA Manager, ACCORDREVIEWED BY: Elspeth CurrieParties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to thelatest versionPage 1 of 3

ACCORDNHS Lothian R&D andThe University of EdinburghSOP Number: CR011v1.0Effective Date: 22/MAR/20111. INTRODUCTIONCompliance with Good Clinical Practice (GCP) ensures that the data and reportedresults are credible and accurate, and that the rights, wellbeing and safety of theparticipants are protected.ICH-GCP E6 Guidelines state that when a trial is completed or prematurelyterminated, the Clinical Study Report (CSR) must be sent to the appropriate licensingauthority(ies). A copy will also be sent to the Research Ethics Committee (REC) asrequired by the applicable regulatory requirements and to the Sponsor(s).It is the responsibility of the Chief Investigator (CI) to submit this report to the relevantorganisations.A report template (CR011-T01 Clinical Study Report template) has been created forCSRs. If the template is used, it may be adjusted as required to contain the relevantsection headings for the type of work conducted. This will ensure overall presentationand content will be similar across all clinical research. Not all sections of the templatewill be applicable for all studies.2. PURPOSETo record the procedures for the preparation and delivery of a CSR.3. SCOPEThis SOP applies to all research personnel involved in the preparation of CSRs inrelation to Clinical Trial of an Investigational Medicinal Product (CTIMP) sponsoredby NHS Lothian and/or the University of Edinburgh.4. REFERENCESThe Medicines for Human Use (Clinical Trials) Regulations 2004/1031, as amendedDeclaration of Helsinki - Ethical Principles for Medical Research Involving HumanSubjects, as amendedICH-GCP E6 Guidelineshttp://www.consort-statement.org/consort-statement/5. PROCEDURE5.1 Report TemplateReports will be prepared, by the Chief Investigator (CI) or designee, using thetemplate CR011-T01 (Clinical Study Report) and each topic will be addressed,except where a section is not applicable. The information required for the CSR maybe captured in another medium, e.g. a report to the funding organisation. In thisParties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to thelatest versionPage 2 of 3

ACCORDNHS Lothian R&D andThe University of EdinburghSOP Number: CR011v1.0Effective Date: 22/MAR/2011instance the CI, or designee, will not be required to use CR011-T01 and will insteadsubmit the information to the Licensing Authority in its already captured format. Ifrequired, researchers can seek guidance and clarification on this matter fromACCORD Quality Assurance personnel at accord.qa@ed.ac.uk.Details of issues documented in filenotes and protocol deviation and violation reportsmay require to be addressed in the CSR depending on their effect on the work.However, the report will always reflect the procedures carried out and deviations willtherefore always be recorded.5.2 Draft ReportDraft reports may be provided to ACCORD Quality Assurance (accord.qa@ed.ac.uk)and to appropriate members of the study team (including, although not neccessarilyexclusively: Investigators, the study manager and study statistician) for review. Otherreviewers may have input into the draft report (eg. the Data Monitoring Committee(DMC) or funders) as specified in the clinical protocol. If a number of drafts arerequired these should be version controlled.5.3 Final ReportDependent on the contract requirements, the Sponsor will be sent one unbound copyof the final report. Reports can be copied double-sided, if required.Any report from a co-operating discipline which is included in the final report shouldbe signed and dated by its responsible scientist. The final report should bedistributed, by the CI, or designee, to all relevant parties within 12 months of the endof trial notification.6. RELATED DOCUMENTSCR018-T01 Clinical Study Report template7. DOCUMENT HISTORYVersion Effective Reason(s) for change(s):Number: Date:n/a n/a New ProcedureParties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to thelatest versionPage 3 of 3