Standard Operating Procedure for Statistical Reports

Transcription

1 Reports_V01.doc Page 1 of 6 Standard Operating Procedure for Statistical Reports SOP ID Number: Effective Date: 22/01/2010 Version Number & Date of Authorisation: V01,15/01/2010 Review Date: 22/01/2012 SOP edocument kept: S:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\ SPONSOR SOPs\SPON_S10 V01.docx SOP for statistical Reports Page 1 of 6

2 Reports_V01.doc Page 2 of 6 Revision Chronology: SOP ID Number: Effective Date: 15/01/2010 Reason for Change: New SOP Author: Rumana Omar, Julie Barber, Gareth Ambler ACRONYMS: JBRU Joint Biomedical Research Unit GCP Good Clinical Practice SOP Standard Operating Procedure SAP Statistical Analysis Plan BSG Biostatistics Group Page 2 of 6

3 Reports_V01.doc Page 3 of 6 Standard Operating Procedure for Statistical Reports 1. PURPOSE This Standard Operating Procedure (SOP) has been written to describe the procedure for preparing and approving statistical reports for a clinical trial. This document is meant for internal use by statisticians in the Biostatistics Group of the JBRU. 2. JOINT UCLH/UCL BIOMEDICAL RESEARCH UNIT POLICY All SOPs produced from the JBRU must be used in conjunction with local NHS Trust and UCL policies and procedures. The JBRU acts as the representative of the Sponsor and will be the official name used on all SOPs. 3. BACKGROUND Statistical reports providing trial results are produced both for the main analysis of the trial and at interim analysis for presentation to the trial data monitoring committee (DMC). The statistical approaches taken will be predefined in the trial Statistical Analysis Plan (See SOP for Writing a Statistical Analysis Plan). 4. SCOPE OF THIS SOP This SOP provides a summary of the procedures for producing statistical reports for the DMC and final trial documentation and is relevant to all trials where members of the JBRU Biostatistics Group are the main trial statistician. 5. RESPONSIBLE PERSONNEL The allocated trial statistician is responsible for producing relevant statistical reports. 6. PROCEDURE Reports will be based on analyses as laid out in the trial SAP. All reports will be reviewed by a senior statistician before being circulated. Reports will be kept in a trial specific electronic directory. For closed reports (such as interim analysis in a blinded trial) these will be filed in a directory with limited accessibility. Reports will be produced in accordance with regulatory requirements for clinical trials. Guidance on content The following provides guidance on the information typically included in statistical reports of trials: 1. Author, date and purpose of report 2. Summary: brief summary of the trial, its design, the intervention(s), objectives and subject population. 3. Objectives: list of the main objectives to be addressed in analysis. Page 3 of 6

4 Reports_V01.doc Page 4 of 6 4. Study design: details of the type of study design (e.g. crossover, phase etc), sample size and details of calculation, definition of study population and sample, randomisation, blinding etc 5. Outcomes: detailed definition of the primary and secondary outcomes for the trial, including information about derivation of outcomes, time point for analysis etc 6. Statistical methods including detail of: statistical methods used for analyses of each trial outcome procedures to check assumptions handling of complexities such as missing data, non compliances, multiple comparisons and centre effects sensitivity analyses planned the software to be used including version number references as appropriate 7. Trial population: A Consort diagram should show the flow of patients through the trial. This and associated text should include detail of: number of patients eligible, recruited and randomised amount of data available at each trial follow up point details of withdrawals, dropouts and non-compliance number of patients with data for analysis of each main outcome 8. Results: Tables, graphical displays and text descriptions should be used to convey results. In particular these should include: a table summarising demographic and clinical data describing patients recruited to the study (by trial group if appropriate). Results from primary and secondary analyses (including efficacy and safety data), including estimates and confidence intervals and where appropriate P- values. All tables and figures should be clearly labelled and referenced with units of measurement defined. Data should be reported to a reasonable number of decimal places. 9. Conclusions and discussion: Interpretation and discussion of the main statistical results from the analysis. This should consider: the impact of assumptions made in analysing the data (perhaps with reference to sensitivity analyses). any design and data quality issues that may impact on trial results. 7. REFERENCES 8. APPENDICES: Statistical analysis plan, trial protocol 9. TEMPLATES/LOGS ASSOCITATED TO THIS SOP 10. SOP DISSEMINATION AND TRAINING This SOP will be provided to all statisticians of the Biostatistics group by the SOP authors. BSG staff will be requested to read the SOP and will given an opportunity to ask specific questions. BSG statisticians will then sign the SOP training log in section 12. Page 4 of 6

5 Reports_V01.doc Page 5 of SIGNATURE PAGE Author and Job Title: Rumana Omar, Julie Barber, Gareth Ambler, Statisticians Signature: Date: Authorised by: Name and Job Title Helen Cadiou, QA Manager Signature: Date: Page 5 of 6

6 12. SOP TRAINING LOG 1 Name of Staff (Capital letters) Job Title: Department: Training Date I confirm that I understand & agree to work to this SOP SIGNATURE Name of Trainer (if training required) Signature Date Page 6 of 6