NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

Transcription

1 NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Statistical Validation of Clinical Trial Protocols and Case Report Forms SOP number: ST 001 SOP category: Statistics Version number: 02 Version date: 17 August 2015 Effective date: 17 September 2015 Revision due date: 17 September 2017 SOP author details Author name: Author position: Author signature: Vicky Ryan Trial Statistician SOP reviewer details Reviewer name: Reviewer position: Reviewer signature: Tom Chadwick Senior Statistician SOP authoriser details Approver name: Approver position: Approver signature: Jill Peacock Quality Assurance Manager STATEMENT This is a controlled document. The master document is held within NCTU with a controlled copy posted on the NCTU website: Any print off of this document will be classed as uncontrolled and should not be filed. The reader is responsible for regularly checking the NCTU website for more recent versions. SOP NCTU: ST 001 Version: 02 Version date: 17 August 2015 Page 1 of 5

2 SOP revision record Version number Date Reason for revision February 2013 Document release August 2015 Biennial review and move onto new template Table of Contents 1. BACKGROUND PURPOSE SCOPE ROLES & RESPONSIBILITES ACRONYMS PROCEDURE Timing Implementation REVIEW AND MONITORING OF THIS DOCUMENT ASSOCIATED DOCUMENTS... 5 SOP NCTU: ST 001 Version: 02 Version date: 17 August 2015 Page 2 of 5

3 1. BACKGROUND The trial protocol should include a detailed and comprehensive statement of the objectives of the trial and the statistical methodology to be employed in order to meet these objectives. A statistician should be involved in the development and review of the trial protocol and case report forms to ensure that, from a statistical point of view, the objectives of the trial may be met. 2. PURPOSE The purpose of this Standard Operating Procedure (SOP) is to define the responsibilities of statisticians in the development, review and approval of clinical trial protocols and case report forms (taken to include all forms of permanent data recording including electronic source data). 3. SCOPE This SOP applies to all statisticians providing statistical support to trials managed through Newcastle Clinical Trials Unit (NCTU). 4. ROLES & RESPONSIBILITES The Trial Statistician is responsible for ensuring that the statistical sections of the protocol are written and for the review of the entire protocol. The Trial Statistician will sign off the final trial protocol and any amendments. The Trial Statistician is responsible for reviewing Case Report Forms along with the allocated Trial Manager and Data Manager. 5. ACRONYMS GCP NCTU SOP Good Clinical Practice Newcastle Clinical Trials Unit Standard Operating Procedure 6. PROCEDURE 6.1 Timing The Clinical Trial Protocol and Case Report Forms shall be written once funding for the trial is confirmed and prior to data collection. 6.2 Implementation The Trial Statistician should review the entire protocol and should be authorised to comment freely on all aspects of the protocol, including amendments. They should be aware of the relevant literature and the results of similar trials. They should contribute to the preparation SOP NCTU: ST 001 Version: 02 Version date: 17 August 2015 Page 3 of 5

4 of the protocol (and amendments) by writing certain sections or by providing information necessary for their completion. They should ensure that the protocol addresses the following items satisfactorily: The proposed design of the trial and whether it is appropriate to the nature of the disease/disorder/problem and its indications, the definition and measurement of the endpoints, and practical constraints such as the availability of participants and other resources. Specific trial objectives with clearly defined and obtainable endpoints. If there is more than one objective or end point, they should be prioritised. Details of the study population with definitions of the inclusion and exclusion criteria. Methods of recruitment and randomisation to intervention groups. Sample sizes which are clearly specified and justified in terms of the trial objectives. The methods and/or computer package used for the determination of sample size should be referenced or documented, as should the estimates of any quantities used in the calculations. The nature of the data to be collected. Details should be given of the methods and timings of data collection. The data collected must be relevant, measured in a consistent manner and appropriate in quantity. Methods of maintaining and breaking any blinded code and the reasons for the degree of blinding adopted. Plans for formal or informal interim analyses or inspections of the data. Note that all unblindings of the data prior to finalisation of the trial represent an interim analysis. Rules for stopping the trial should be within the remit of the independent Data Monitoring Committee. Plans for sample size reviews, with a view to the possibility of altering the planned number of participants, conducted in a blinded and non comparative way. Details of specific statistical hypotheses that are to be tested or specific parameters to be estimated in order to meet the objectives of the trial. Methods for accomplishing these should be stated. Details of the rules that will be used to determine the evaluability of participants, especially in cases of protocol violations, withdrawals or dropouts (see SOP NCTU ST 002, Defining the Analysis Groups). The general strategy for dealing with each category of data. It is suggested that the data be classified under such headings as demographic characteristics, concomitant medication, medical history, dosing and treatment schedules, efficacy measurements, laboratory and other safety data, adverse event reports, etc. or by type of data. SOP NCTU: ST 001 Version: 02 Version date: 17 August 2015 Page 4 of 5

5 Compliance with the statistical aspects of the appropriate GCP guidelines. The statistician should ensure that the case report forms are designed to collect data as required by the protocol. The case report forms should only include relevant items that are planned to be evaluated in the final report. 7. REVIEW AND MONITORING OF THIS DOCUMENT This SOP will be reviewed every two years unless there is a change to the applicable legislation or significant revision to the process contained in the SOP. The use of this SOP will be monitored through internal audit 8. ASSOCIATED DOCUMENTS NCTU SOP ST 002 Defining the Analysis Groups SOP NCTU: ST 001 Version: 02 Version date: 17 August 2015 Page 5 of 5