Computer System Validation for Clinical Trials:
Contents
1. 13 5 2 Training records for computerised systems may refer to a training SOP ccscccccssseceesseseeeeeees 13 6 SQ CUMIEY 233502555 E EE 13 6 1 Password assignment and ChANQeS ccccesssssececececeesssaesecececseesaeseecesceesesaesececscseseaaeeeeeesceesesasaeeeesees 13 6 2 Access authority levels and their review sesenta en tern nn nsns en nr an 13 6 3 Physical security i E oe c E re eese a o e PR RA Er Pr on RR ET uhi PER ed Feo e ria aee 13 6 4 Vir s checking and prevention eite tee Incerti Rete eee eh eee epe ee uk a Fen Poe ex ERR iaaea 13 7 System Use and Maintenance naese eee a Re aa Ra e e aE aE a a a EEE EREE 14 7 1 UEO A IAT ENEE EE A E IE T A E EE E 14 8 User SUPPONE ane an a ai a a a a a ae a a eed o a i a a aes 14 8 1 S pport help for probletris a aa euis Poele casto A Rer oves cane l Ea E Rer ATL RE EPA EUR 14 8 2 User Manuals and training Maintenance cccccccccccssscccssssececsssceceesseeecesssececessseceesaeeecsesaeceenssseceees 14 9 Problerm Managetient uite eme Fem aere SO x e RD ec rasgo etu CR eh EB 14 9 1 Issue log con Reo eo Ite een Hehe ned A inde c Toe E etn deus RM Ref r ae 14 9 2 Monitoring and resolution oci cr et ERE E o ERO ER eO EET ERE RATER SERRRK ERES Ve RR 15 10 System Backup and Restoration 5t ae eee et eee eue ee ne d en et ee ec ree en re en ee E eene en 15 1047 Routine backups ihre tas etre I decet Meet code o edet n Eee dee qo es is 15 102. e Complete Appendix B1 Requirements Specification and Appendix B2 Needs Analysus e Print and sign by the Chief Investigator or nominee e Ensure the Requirements Specification is stored in the Trial Master File and referenced in the Validation Plan Appendix A 2 2 FUNCTIONAL SPECIFICATION Functional specification documentation should include detail on how the requirements outlined in the Requirements Specification 2 1 will be achieved Specification will be from the end user perspective and may include workflow diagrams screen mock ups and full description of all features required and how they are to be used by the end user Page 8 Framework Standard Operating Procedure Computer System Validation for Clinical Trials Include how the end user will be required to use the software data entry any data validation rules required data output requirements and reports e Refer to the University Data Management SOP e Ensure a full and detailed functional specification user driven has been completed for any bespoke software or database development e Print and sign by the Chief Investigator or nominee e Ensure the Functional Specification is stored in the Trial Master File and referenced in the Validation Plan Appendix A 2 3 DESIGN SPECIFICATION Design specification documentation should include more technical detail including what application development model should be adopted any data flow processes including databa
3. Produce Management Report Section 4 4 Page 17 Framework Standard Operating Procedure Computer System Validation for Clinical Trials Validation Documentation Date Document Location Completed Request for Change Sections 4 7 12 2 Appendix G Access Control List Section 6 2 Physical Security of the System Protocol Section 6 3 Create System Use and Maintenance SOP Section 7 1 Issue Log Sections 8 1 9 1 9 2 Appendix H User Manuals Training Material Section 8 2 System Backup Process Section 10 1 Appendix Backup Log Section 10 2 Restore Procedure Section 10 3 Disaster Recovery Plan Section 11 1 Appendix J SYSTEM RELEASE Agreed System Release Date Approved By Provide description of what part s of the system is being released continue as necessary Page 18 Framework Standard Operating Procedure Computer System Validation for Clinical Trials PERIODIC REVIEW Name of Reviewer Frequency of periodic review Reviewed By Date Action Required Completed continue as necessary Page 19 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX B REQUIREMENTS SPECIFICATION TEMPLATE NAME OF TRIAL NAME OF COMPUTERISED SYSTEM Author Tim Cross Current Version Date 0 1 Draft 16 Jan 2013 Approved By Date Position
4. REVIEWED Initials Date 1 Requirement Completed by the Chief Investigator or Nominee Include the name of the trail Outline in detail the requirement for a computer system hardware or software and how this is to be used within the trial and how this may impact on the integrity and quality of clinical data 2 Needs Analysis Completed by the Chief Investigator or Nominee Is there a supported and validated University application or equipment that will meet the above requirement e g SPSS Is there an off the shelf pre validated computer system that will meet the above requirement Is there a hardware requirement e g scanner server Is this currently available suitable Is there a software development requirement Reference supporting documentation such as proposal or needs analysis Ensure all requirements are specified including post trial requirements such as archiving data lockdown data preservation retention period etc Page 20 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX C TEST PLAN LOG TEMPLATE Author Tim Cross Current Version 0 1 Draft Date 16 Jan 2013 Approved By Date Position REVIEWED Initials Date NAME OF TRIAL NAME OF COMPUTERISED SYSTEM If Test Script is used note name and location of Test Script No Date Tested By Screen Form or Module Name Success Fail Error Message or Observations Action
5. Any documentation completed as part of the System Validation Plan must be kept secure within the Trial Master File and adheres to access control mechanisms in place 1 2 STANDARDS Documentation standards will be developed and applied generically via the IT amp Information Management Working Group ITIM which is a sub group of the Clinical Trials Management Group where applicable 1 3 REVIEW AND APPROVAL The System Validation documentation including this SOP its appendices and documentation referenced within will be reviewed periodically by the ITIM Group and will be signed off by the Chair of the Group upon any change to the documentation 1 4 DISTRIBUTION The SOP will be made available to nominated trial staff through the University network Any validation documentation completed must be kept securely within the Trial Master File TMF whether electronic or paper format and distributed in accordance to the trial procedures in place 1 5 ACCESS CONTROL Access to the validation documentation should be kept secure in accordance to any procedures currently in place for the TMF Page 7 Framework Standard Operating Procedure Computer System Validation for Clinical Trials 1 6 VERSION CONTROL Any changes to this SOP will be clearly indicated by the version number on the SOP cover sheet and document filename Any changes to completed validation documentation as referenced in this SOP must be clearly indicated by incrementing
6. COMPUTERISED SYSTEM To validate a computer system has been successfully installed Record any installation observations and tests conducted to evidence the system has been installed successfully To be completed by the person installing the system Date Installed By System Installation Notes and Post Success Fail Action Required Installation Test Page 23 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX F USER ACCEPTANCE SIGN OFF TEMPLATE Author Tim Cross Current Version 0 1 Draft Date 16 Jan 2013 Approved By Date Position REVIEWED Initials Date NAME OF TRIAL NAME OF COMPUTERISED SYSTEM To be completed by the end user including for future releases bug fixes additional modules etc The development of the modules forms or database as listed below have tested in accordance with the requirements specification including any post testing issues identified and recorded in the Test Log The modules forms or database as listed below have been tested by using test scripts by the end user and have been validated successfully including re testing following any issues identified during a previous test The End User is satisfied that the following modules forms or database has passed user testing and is fit for purpose as specified The following modules forms or database can be released onto the production system Module Form Da
7. TESTING METHODOLOGY e Ensure testing is done on a system other than the live production system The test system must be as identical to the live production system as possible but must be separate to ensure there is no contamination of live data with test data Page 11 4 2 4 3 4 4 4 5 4 6 4 7 Page 12 Framework Standard Operating Procedure Computer System Validation for Clinical Trials Detailed test scripts must be written to include test data and expected results For example document the input variables of a dummy patient which can then be entered onto the system including expected data outputs Different scenarios should be tested Test scripts should also include boundary values or incorrect values to ensure any form or rule based input validation works as expected TESTING SUCCESSES AND FAILURES Record all testing successes and failures in the Test Plan Appendix C including any remedial action required Any test failures must be re tested following the completion of the remedial action DOCUMENTATION DEVELOPMENT AND RETENTION Print and sign all User Acceptance Test documentation by the Chief Investigator or nominee Ensure the User Acceptance Test documentation is stored in the Trial Master File and referenced in the Validation Plan Appendix A Refer to Section 1 for applicable document management procedures If applicable archive previous version Complete the document control header for each doc
8. non clinical trial computer systems that are being implemented to ensure the system being implemented is fit for purpose and appropriately controlled iv RESPONSIBILITY FOR SYSTEM VALIDATION As part of the clinical trial setup procedure the Chief Investigator or nominated member of the trial team are required to have an interview with the Trial Unit Information Officer to discuss IT requirements in detail which will include advice on validation For non Clinical Trial Unit trials IT requirements must be discussed with the Schools IT Manager Further advice and support is available from the School IT Office throughout the process but it should be noted that the responsibility for validation lies with the owner and users of the business system which would usually be the Chief Investigator or nominated member of the trial staff V SOP OWNER AND APPROVAL The Computer System Validation SOP is owned by the IT amp Information Management Working Group a sub group of the Clinical Trials Management Group who is responsible for the development of the SOP subsequent review and implementation of any SOP changes f Computerised Systems Validation in Clinical Research A Practical Guide 2 Edition CR CSV Working Party Association for Clinical Data Management 2004 Used throughout and indicated by italicised text in quotes Page 5 Framework Standard Operating Procedure Computer System Validation for Clinical Trials CLINICAL TRIAL SYSTEM VALID
9. 2 Back piloB inia nee net ee Dedi o Mine atre Re eee DR HP veces o Ree eoa E HA Ce VER uae ss 15 10 3 Restoration of system and data u ccceccccccccecsesseesecececseseeaeeecececseeeassececsceeeeaseeseesceesesesseseeseseseaaaeees 15 11 Bu siness Coritin ity oriri ceevanabebebasdccvevastesioeh bade chevacebebehdidecvebastushabhide cbenasebebebasbecbebbateseeh ae eee age 15 11 1 System recovery in the event of a major disaster may reference disaster recovery plan 15 Page 3 Framework Standard Operating Procedure Computer System Validation for Clinical Trials 12 Change Management ette qe ton me eee EE eta eee ue URP dee E oen aseo Ae e ee need va pas 15 12 1 Documentation and maintenance of the system configuration esee enne 15 12 2 Documentation prioritisation and authorisation of changes to validated systems 16 12 3 Development testing documentation and review of changes ccccsesscccccecsessseeeeeeeceessseeeeesens 16 12 4 Installation of changes and provision of training seen ener nns 16 13 Periodic REVIEW ae re iie E aE dene ee EEE EEEE TE ERa TOE ESE EEE ETE N 16 13 1 Revalidation requireMents cccccccccssssecccccecsessseeeeeececseseeaeseeececeeseeaeeeeececeeeeaseeseesceesesaeseseeseesseaaaeees 16 13 2 hurt AT E AE A A A AA E A 16 Appendix A Validation Plan Template c cccccccccssssssscececsesessesesececeeseeeeesecsceesese
10. AME OF TRIAL NAME OF COMPUTERISED SYSTEM 1 Type of Backup Describe the type of backup and the medium used Include whether backup is a complete system backup data backup or incremental 2 Backup Routine Describe the regularity and routine of the backup Include who is responsible for conducting the backup Describe the retention policy 3 Backup Log Describe how a log of the backup is to be maintained Page 27 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX J SYSTEM DISASTER RECOVERY TEMPLATE Author Tim Cross Current Version 0 1 Draft Date 16 Jan 2013 Approved By Date Position REVIEWED Initials Date NAME OF TRIAL NAME OF COMPUTERISED SYSTEM Directory No Service Name 1 a example Service Description include dependencies critical files data store etc Account Name Account Password Account Description Add more rows if necessary Backup Procedure include types of backup critical files location etc Page 28 Framework Standard Operating Procedure Computer System Validation for Clinical Trials Restore Procedure Directory Version Comments Page 29
11. ATION PROCEDURE FLOW DIAGRAM gam Periodic Review Required No Yes No NS Document Management System Release Aim g Procedure Yes Installation Log Requirements Specification Requeg For Change Yes Development Requeg Functional Specification Design Specification Developer handover User Manuals Training Management Report Test Scripts User Acceptance Test Plan Log Page 6 Framework Standard Operating Procedure Computer System Validation for Clinical Trials PART 2 FRAMEWORK STANDARD OPERATING PROCEDURE F SOP 1 DOCUMENTATION MANAGEMENT This section describes the procedure for the security development and management of any System Validation documentation including this SOP its appendices and documentation referenced within The Chief Investigator or nominated delegated authority is responsible for document management If a Clinical Trial Unit has its own SOP on document management then this should be used as an alternative to this section 1 1 SECURITY 1 1 a System Validation SOP This SOP documentation must be stored on the University network for the purposes of editing and amending within a secure folder accessible by document authors only The full path to the current document version must be included in the SOP cover sheet A document management system such as Q Pulse can be used as an alternative storage and control mechanism 1 1 5 Other Validation Documentation
12. DATION OF COMPUTERISED SYSTEMS e All staff involved in the validation of computer systems must be appropriately trained 3 2 TRAINING RECORDS FOR COMPUTERISED SYSTEMS MAY REFER TO A TRAINING SOP e All end users must be appropriately trained in the computer system being validated e Allend users must have training recorded in the training plan 6 SECURITY The Chief Investigator or nominated delegated authority is responsible for ensuring the system has an appropriate level of security in place 6 1 PASSWORD ASSIGNMENT AND CHANGES Ensure any access to the system and any password assignment is in accordance with the University s Regulations and Acceptable Use including e University IT Systems Password Policy Schedule 7 http www cardiff ac uk insrv resources regulationsandstrategy insrvregulationsjuly2012 pdf e University Permission to Connect to the IT Network Policy http www cardiff ac uk insrv aboutus regulations index html 6 2 ACCESS AUTHORITY LEVELS AND THEIR REVIEW e Maintain an Access Control List of who needs access to the system being validated including review dates e Ensure the Access Control List is stored in the Trial Master File and referenced in the Validation Plan Appendix A 6 3 PHYSICAL SECURITY e Ensure any host system is secured appropriately including workstations and servers to prevent unauthorised access e Document a physical security protocol outlining how the system secured against unau
13. E RASKE 8 1 7 Chane SAIS COU s sieer E e E EE RA 8 1 8 Archiving amp Retention POlicy scescssssceesceseseeeeececssneecacecsaeeeeacessaeeeenaessaeeseceessaeeeeeaessaeseeaeesnaeeseneees 8 2 Software Development and Testing Including One off Programs sss 8 2 1 Requirements Specification Needs Analysis essen ener nnne 8 2 2 Functional femora poison 8 2 3 RTT yetsr Ten i Tor fo je 9 2 4 Test Plan Results tero etritest oaieacusdheosedssscedoveabonteddondaasessbensseicobenatecdadbandvaceseveansd sadedunsadectavsn 9 2 5 Testing Failures Exception Handling c cesccccssccsceesceseeeceaeeseesecaeesecaeseeceaeeeeaecaeeeecaesenceaseeseaeeateaeeaeeats 9 2 6 Change Version Control cecceccessesceseeseesecaeesecaeeenceaeeeceaecaseeecaesencaaseceaecaseaecaesencaeseceaeeeseaeeaeeaseaeeats 10 2 7 User Manual and Training development eese enne enne enne enne nnne 10 2 8 Programming Standards reete rettet erii nene Here Ene aee eie duc HB CERCHI eee i ninia eE 10 2 9 Documentation Sign Off and Retention esesssssssssssssesesenee nere enne nnne trennen nest nss 10 2 10 Release and Installatiori eire rait erba ker hti reine Rape Ere RE inea aan ERE 11 3 System Set up and Installation 5 oreet Geni Dei rete etre n tre ena seen aee Ee Hk pk R repa ee Ya EE eaa Ma EE EERE Euh d 11 3 1 System configul ation anecono terrier rnt thier Fr HR EP eta H
14. Framework Standard Operating Procedure Computer System Validation for Clinical Trials School of Medicine IT Office Computer System Validation for Clinical Trials Framework Standard Operating Procedure F SOP Author Tim Cross Version History 0 1di DRAFT Date 24 April 2013 0 2 DRAFT 12 June 2013 Current Version 1 0 17 June 2013 Approved By ITIM Date 17 June 2013 Position REVIEWED Initials Date Document Filename System Validation SOP 0 1 docx Document Location shrmedic MEDIC Shared DNMED School of medicine central administration IT Clinical Trials NGovernance and MHRA Page 1 Part 1 Operating Procedure Definition and Scope ccccccesccssssccssecesscecsecseceecsaeceeeeecsaecseneecaeceeeeecsaesseeeeeeaeeeeees 5 Procedure Flow Diagtatrm ucer i tete imp ER eae EFE Pa PERE ERI eSa CREE OEC naa Eba BER RR ERR xA ERA Re RAE DRE R ERE 6 Part 2 Framework Standard Operating Procedure F SOP cccccsssccsssessssecsescesseecsseessseecssecesseecseeeeeaeecsaeeseaees 7 1 Documentation Mariagement nri n EP ERR RER REF sians a EEE SEPESI EAEN NISSER r ESS SEISNE 7 1 1 ke 7 1 2 SEAM GANAS Mtm 7 1 3 REVIEW andi Approval E N 7 1 4 DISERIDUILION OM D aaa a AEN EN a AN EE R A EE AE 7 1 5 ACCESS ro 0 d ro PER EM E 7 1 6 VEFSIOMCOMENOL sscan ae a en A e a a E E E rE a a E a NEn e OSA EEN
15. Required Page 21 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX D SATISFACTORY COMPLETION AND HAND OVER TEMPLATE Author Tim Cross Current Version 0 1 Draft Date 16 Jan 2013 Approved By Date Position REVIEWED Initials Date NAME OF TRIAL NAME OF COMPUTERISED SYSTEM To be completed by the developer The development of the modules forms or database as listed below have been completed by the Developer including any post testing issues identified and recorded in the Test Log The modules forms or database as listed below have been tested by the end user and have been validated successfully including re testing following any issues identified during a previous test The End User business owner is satisfied that the following modules forms or database has passed user testing and is fit for purpose as specified The following modules forms or database can be uploaded onto the production version Module Form Database Version Date Signed Developer Date Signed End User Normally Chief Investigator Date Page 22 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX E INSTALLATION TEST LOG Author Tim Cross Current Version 0 1 Draft Date 16 Jan 2013 Approved By Date Position REVIEWED Initials Date NAME OF TRIAL NAME OF
16. ach screen should be tested with expected values and any data entry validation rules should be tested Any system or data errors should be noted and re tested until all tests are satisfactory For incremental or iterative system development a Test Plan should be provided for every software release patch or additional module within the development lifecycle Refer to Section 4 User Acceptance Testing for the procedure for releasing development and test systems to a production environment 225 TESTING FAILURES EXCEPTION HANDLING e Record all test results and outcomes and specify if the test was a success or fail e Record any testing failures and action required in the Test Plan Appendix C Page 9 2 6 2 7 2 8 Framework Standard Operating Procedure Computer System Validation for Clinical Trials Re test any function that failed and record in the Test Plan and record any further action if necessary Record any system exception messages in the Test Plan and record any further action required ensuring every scenario is re tested Ensure appropriate exception handling is controlled in the application to enable end user to record any system errors during testing or use automatic exception notifications CHANGE VERSION CONTROL Complete the document control header for each document produced including author version incremental approved by Initials and date reviewed by initials and date Previous version must be archived in accord
17. ance with the University Standard Operating Procedure for Archiving records from clinical trials of investigational medicinal products to ensure traceability and historical information preservation Software code must have appropriate version control preferably through an automated version control repository or via the source code Document any change request in a Change Request Log Appendix G see also Section 12 of this SOP Software changes must be documented by the developer in the programme source code USER MANUAL AND TRAINING DEVELOPMENT A User Manual or user guide must be produced in order to provide end users with appropriate guidance on how to use the system developed A new version of the User Manual should be produced after any major software change Ensure the User Manual is stored in the Trial Master File and referenced in the Validation Plan Appendix A Ensure electronic copies are stored securely on the University network ensuring filenames include the relevant version number If applicable archive previous version PROGRAMMING STANDARDS Source code development standards should be specified to ensure the quality and consistency of software code This should be stated during the design specification and used consistently throughout the development cycle DEO Page 10 Agree source code standards and ensure this is specified in the design specification document Source code must be well documented includin
18. ere ER aana En RE TNR a rper Hoa Er Rae Rep ES 11 3 2 kfagdduIm 11 3 3 Installation test amp documentation sesesseseeeeeseee eene enne nnne sdis sid en nennen nennen 11 4 User Acceptance Testing rr pi tr ei apre RR n Rp ku EE RRE E EE EES XX RA EE RES EE ER Re RERRR E REFER a PERRA EREE SNARE 11 Page 2 Framework Standard Operating Procedure Computer System Validation for Clinical Trials Framework Standard Operating Procedure Computer System Validation for Clinical Trials 4 1 Testing methodology re e Secs ee E yack xe re vno vce Neco or RYE RR Nee e ERRARE decodes 11 4 2 Testing Successes and failures eesssssessssssssseseeeseeee iii en trn nnns sister OTRE EERE EE 12 4 3 Documentation development and retention ccceccessssccccecsessseeceeececseseaesecececeesesaeeesececeeseaseeeeesees 12 4 4 Reporting ANG sIghz Off eroe ener adds oe ed exea Cone eu enn E E ee pesce gae eene a Pe ree enar rn a Tae eve udo 12 4 5 Acceptance criteria for authorisation of a valid system for use ccccccccccccessesseeeeeecessesseaeeeeeeeeseees 12 4 6 Formal acceptance of the system c cccccccccsssssecececscseseaesecececsesesaeseeeesceeseeaesececsceeseaaeeeseesceeseaeaeeeeeees 12 4 7 Ongoing validation iro poudre HERR eee Eon ta e Pen E e Ene SEa Ee ee EEA 12 5 Uc 13 5 1 Training requirements for staff involved in the validation of computerised systems
19. g Procedure Computer System Validation for Clinical Trials e Any approved change request must be reflected in the Requirements Specification Design Specification and any other relevant validation documentation Amend these documents according to document control mechanisms see section 4 3 12 2 DOCUMENTATION PRIORITISATION AND AUTHORISATION OF CHANGES TO VALIDATED SYSTEMS e Register and document any change requests by completing Appendix G Request for Change template to assess change request and gain authorisation for the implementation of the change request 12 3 DEVELOPMENT TESTING DOCUMENTATION AND REVIEW OF CHANGES e Re validate any component of the system affected by the change request in a test environment e Archive redundant source code and documentation 12 4 INSTALLATION OF CHANGES AND PROVISION OF TRAINING e Inform end users of the proposed change and provide training and amend any user guidance documentation as appropriate e Announce an install date to end users for the implementation of the chance and install the required change following the validation procedure outlined in this document 13 PERIODIC REVIEW The Chief Investigator or nominated delegated authority is responsible for periodic review 13 1 REVALIDATION REQUIREMENTS e Conduct and document a Periodic Review to ensure the system documentation is up to date and the validated system is functioning according to the Requirements Specification The Validation P
20. g source code comments maintain header information such as author version date and any explanatory coding notes DOCUMENTATION SIGN OFF AND RETENTION Upon satisfactory user testing ensure that a satisfactory completion hand over document has been signed and filed with the validation documentation This should be signed and dated by the Chief Investigator and the Developer Complete Appendix D Satisfactory Completion amp Hand over template Ensure all validation documentation is signed by the Chief Investigator and stored in the Trial Master File Ensure all versions of the validation documentation both hard and soft copies are retained in accordance with the University archiving policy Framework Standard Operating Procedure Computer System Validation for Clinical Trials 2 10 RELEASE AND INSTALLATION e A system release date must be agreed between the end user and developer software provider and documented in the Validation Plan e Postinstall checks must be made and documented to verify successful installations see Section 3 below 3 SYSTEM SET UP AND INSTALLATION The Chief Investigator or nominated delegated authority is responsible for system set up and installation 3 1 SYSTEM CONFIGURATION Ensure the host computer system e g workstation or server meets the system configuration requirements for the system being validated including server workstation operating system processor and memory specifications e Ens
21. lan Appendix A should state who is responsible for the Periodic Review business owner and the frequency e Review of Issue Log to evaluate any reoccurring issues or major problems e Review user training and training records e Review Validation SOP and Validation Plan Appendix A and ensure all documentation is up to date 13 2 RE TESTING e Reviewer should conduct and document an assessment of any risk identified by the periodic review and revalidate the system if necessary SOP headings and titles were adapted from Computerised Systems Validation in Clinical Research A Practical Guide 2 Edition CR CSV Working Party Association for Clinical Data Management 2004 Appendix 4 Page 16 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX A VALIDATION PLAN TEMPLATE Author Tim Cross Current Version Date 0 1 16 Jan 2013 Approved By Date Position REVIEWED Initials Date NAME OF TRIAL NAME OF COMPUTERISED SYSTEM Bespoke Software Database development only Validation Documentation Date Document Location Completed Requirements Specification Section 2 1 Appendix B Functional Specification Section 2 2 Design Specification Section 2 3 Test Scripts Section 4 1 Test Plan Log Sections 2 4 4 Appendix C Satisfactory Completion amp Hand over Appendix D User Acceptance Sign Off Section 4 6 Appendix F
22. mplate Appendix I and store this document in the Trial Master File and ensure it is referenced in the Validation Plan Appendix A 10 2 BACKUP LOG For data stored on systems other than the University shared drive which is routinely backed up e Maintain a backup log to include who and when backups are undertaken This may be provided by electronic and automated backup logs 10 3 RESTORATION OF SYSTEM AND DATA e Arestore procedure must be documented and referenced in the Validation Plan Appendix A e The restore procedure may be part of an established SOP or disaster recovery plan if so ensure it is referenced in the Validation Plan 11 BUSINESS CONTINUITY The Chief Investigator or nominated delegated authority is responsible to ensure an appropriate business continuity procedure is in place 11 1 SYSTEM RECOVERY IN THE EVENT OF A MAJOR DISASTER MAY REFERENCE DISASTER RECOVERY PLAN e Ensure a disaster recovery plan exists for every system validated Use Appendix J System Disaster Recovery Template if one does not currently exist e Any disaster recovery document must be securely located with appropriate access control e Ensure the disaster recovery plan is referenced in the Validation Plan Appendix A 12 CHANGE MANAGEMENT The Chief Investigator or nominated delegated authority is responsible for change management 12 1 DOCUMENTATION AND MAINTENANCE OF THE SYSTEM CONFIGURATION Page 15 Framework Standard Operatin
23. se structure key deliverables and source code documentation Include how the software database should be delivered and how any design changes should be managed e Ensure a full and detailed design specification has been completed for any bespoke software or database development e The design specification must be completed by a qualified vendor developer e The design specification should outline how it meets the requirements specified e The design specification should be printed and signed by the Chief Investigator or nominee as well as the vendor developer as part of the design qualification e The design specification should state how change requests are implemented and managed post design sign off e A formal handover letter should be produced by the developer vendor and signed by the Chief Investigator indicating that the design meets user specification and is ready for testing e Ensure the Design Specification is stored in the Trial Master File and referenced in the Validation Plan Appendix A 2 4 TEST PLAN RESULTS The software or database development or any off shelf system such as SPSS Microsoft Access etc must be fully tested by the end user against the requirements functional and design specifications to ensure any data input and output produces the required result The test should be conducted on the client hardware software that is to be used in the trial for instance an iPad or correct version of Internet Explorer E
24. sseseesceesesesaeseesessseeeaeseeseseeeneea 17 Appendix B Requirements Specification Template cccccsssscccccceesessecesecececseeseeseeececseeeaeseeseesseeeaeseesesseesees 20 Appendix C Test Plan Log Template cccccsssscssscesssecssecesssecsecessecsaeceeseccssecesseecsaecesseecsaecesecesaeceeseeenaeeesnees 21 Appendix D Satisfactory Completion and Hand over Template sess 22 Appendix E Installation Test Log ssii csi cccdsesencevssdlastevetegiavesisssevesdcadetssisaateancedesesedssaetandecsedexscaaediedchevveedlan ee EPA SEE 23 Appendix F User Acceptance Sign Off Template lessen eene nnnnnn nne en tnt an assess entran 24 Appendix G Change Request Template cccccccccsssssccececsessssesesececesseseeeseeeceeseseeaeseeecessesesaeseescesseseeaeseesesesesees 25 Appendix H Issue Log Template cccsssssccecessssssassecececsessnassecececsesseeseesecscsesaeessesecsesesesaeeeseesseesesasaesecsesenenaes 26 Appendix System Backup Process Template esses enne nnne nennen esent nn nsns en nr an 27 Appendix J System Disaster Recovery Template cccccccccsessscecececeesessececececeeseseseesececessesesaeseescesseseeaeseesesseegees 28 Page 4 Framework Standard Operating Procedure Computer System Validation for Clinical Trials PART 1 OPERATING PROCEDURE DEFINITION AND SCOPE i VALIDATION DEFINITION Computer system valida
25. tabase Version Date Signed End User Normally Chief Investigator Date Page 24 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX G CHANGE REQUEST TEMPLATE Author Tim Cross Current Version 0 1 Draft Date 16 Jan 2013 Approved By Date Position REVIEWED Initials Date NAME OF TRIAL NAME OF COMPUTERISED SYSTEM RFC Date Received Change Description Impact of Change Approved Declined Include name and signature if approved 1 2 3 4 etc RFC Request For Change number Page 25 Author Tim Cross Current Version 0 1 Draft Date Approved By Date Position REVIEWED Initials Date NAME OF TRIAL Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX H ISSUE LOG TEMPLATE 16 Jan 2013 NAME OF COMPUTERISED SYSTEM Nominated Issue Log Owner No Issue Date Recorded By Screen Form or Module Name Issue Description Remedial Action Date Resolved Include any error message Include any support reference number 1 2 3 Page 26 Framework Standard Operating Procedure Computer System Validation for Clinical Trials APPENDIX SYSTEM BACKUP PROCESS TEMPLATE Author Tim Cross Current Version 0 1 Draft Date 16 Jan 2013 Approved By Date Position REVIEWED Initials Date N
26. the version number date and author at the top of each document using the templates provided in the appendices 1 7 CHANGE HISTORY Any changes to completed validation documentation as referenced in this SOP must be fully auditable Any previous version of the documentation must be stored and indicated by the version number at the top of the document template and by the document filename and stored securely on the University network Alternatively an approved document management system can be used such as QPulse which retains historical information maintains version control and imbeds electronic signatures 1 8 ARCHIVING amp RETENTION POLICY All validation documentation must be retained in accordance with the University Standard Operating Procedure for Archiving records from clinical trials of investigational medicinal products 2 SOFTWARE DEVELOPMENT AND TESTING INCLUDING ONE OFF PROGRAMS This section describes the procedure for producing documentary evidence to verify that any software including database developed or used for a clinical trial has been specified designed tested and signed off prior to the implementation The Chief Investigator or nominated delegated authority is responsible for software development and testing Indicates requirement applicable to bespoke software or database development only Everything else is applicable to ALL computer systems as defined in Part I 2 1 REQUIREMENTS SPECIFICATION NEEDS ANALYSIS
27. thorised access or theft Store this document in the Trial Master File and ensure it is referenced in the Validation Plan Appendix A 6 4 VIRUS CHECKING AND PREVENTION Page 13 Framework Standard Operating Procedure Computer System Validation for Clinical Trials e Ensure system is complaint with the University s anti virus policy and the approved University s antivirus software is installed on the systems being used http www cf ac uk insrv it antivirus index html e Refer to the Information Services Regulations and Acceptable Use policies http www cardiff ac uk insrv aboutus regulations 7 SYSTEM USE AND MAINTENANCE Clinical Trial Units should adapt this section according to local procedures The Chief Investigator or nominated delegated authority is responsible for System Use and Maintenance 7 1 AN SOP FOR EACH SYSTEM e Create a System Use and Maintenance SOP and include any maintenance or support contract for software and host systems e Include a statement of support from the developer or vendor including any service level agreement e Store this document in the Trial Master File and ensure it is referenced in the Validation Plan Appendix A 8 USER SUPPORT The Chief Investigator or nominated delegated authority is responsible for user support 8 1 SUPPORT HELP FOR PROBLEMS e Document the procedure for obtaining support in event of system issues and failures Include support contact information e Record any iss
28. tion is to demonstrate that a system consisting of a controlled business process which has attributes of People and Procedures Hardware and Software is fit for purpose performs consistently and that changes are effectively controlled Validation applies to all systems that may impact on the integrity and quality of clinical datat ii VALIDATION POLICY All systems used within a clinical trial must have appropriate validation documentation in place as outlined and referenced within this standard operating procedure Where indicated the validation templates in this SOP must be used throughout the validation lifecycle iii SCOPE OF VALIDATION POLICY AND F SOP This Framework Standard Operating Procedure F SOP is to be used as a basis for the development of a SOP for all non validated computerised systems that are used within a clinical trial setting The Framework SOP should be adapted as appropriate for the development of a system validation SOP as appropriate to the clinical trial The validation tasks outlined in the SOP must be done prospectively for all computer systems used in a clinical trial A clinical research computerised system is defined as The set of hardware software procedures and people which together perform one or more of the capture transmissions processing analysis and reporting functions on clinical trial data management of the clinical development programme This F SOP can also be used as a guide for other
29. ues or failures in the Issue Log Appendix H including any support reference number remedial action and date resolved 8 2 USER MANUALS AND TRAINING MAINTENANCE e Reference any user manuals and training material in the Validation Plan Appendix A e Ensure any future releases of the computer system being implemented have up to date user manuals PROBLEM MANAGEMENT The Chief Investigator or nominated delegated authority is responsible for problem management 9 1 ISSUE LOG e An Issue Log Appendix H must be maintained for each system being validated throughout the period of the Clinical Trial e Ensure the Issue Log is stored in the Trial Master File and referenced in the Validation Plan Appendix A Page 14 Framework Standard Operating Procedure Computer System Validation for Clinical Trials 9 2 MONITORING AND RESOLUTION e Anominated member of staff must be responsible for maintaining the Issue Log and ensure the Log is kept up to date and any resolutions noted including resolution date e Nominee must be named on the Issue Log Appendix H under Issue Log Owner 10 SYSTEM BACKUP AND RESTORATION The Chief Investigator or nominated delegated authority is responsible to ensure that an appropriate level of system backup and restoration procedures are in place 10 1 ROUTINE BACKUPS For data stored on systems other than the University shared drive which is routinely backed up e Complete the System Backup Process te
30. ument completed including author version incremental and date approved by Initials and date reviewed by initials and date REPORTING AND SIGN OFF Produce a brief management report including the outcome of the user acceptance tests conducted and the system fit for purpose for the given Clinical Trial The Report must be stored in the Trial Master File and referenced in the Validation Plan Appendix A ACCEPTANCE CRITERIA FOR AUTHORISATION OF A VALID SYSTEM FOR USE Ensure all criteria outlined in the requirement specification document Appendix B have been met by the provided system Ensure all test scripts have been satisfactory completed FORMAL ACCEPTANCE OF THE SYSTEM Complete the User Acceptance Sign Off template Appendix F which must be stored in the Trial Master File and referenced in the Validation Plan Appendix A ONGOING VALIDATION Register and document any change requests by completing Appendix G Request for Change template to assess change requests and gain authorisation for the implementation of the change request Re validate any component of the system affected by the change request in a test environment Framework Standard Operating Procedure Computer System Validation for Clinical Trials 5 TRAINING A clinical trial may refer to their own Training SOP if appropriate The Chief Investigator or nominated delegated authority is responsible for Training 5 TRAINING REQUIREMENTS FOR STAFF INVOLVED IN THE VALI
31. ure any system dependencies specified are pre installed and available on the host computer system If system is delivered via a web browser ensure supplier recommended web browser version e g Internet Explorer Firefox Chrome is available and installed correctly for its use Check whether appropriate system user rights are available to ensure successful installation Workstation Administrator rights may be required for software installation onto client PC s 3 2 SET UP OPTIONS e Follow guidelines from the supplier or vendor of the computer system being validated to ensure all appropriate set up options have been completed as appropriate to the required use e Consider most appropriate delivery of client software such as workstation installation via Networked Applications user authenticated installation or direct installation 3 3 INSTALLATION TEST amp DOCUMENTATION e Complete the Installation Test Plan Appendix C and record any installation observations and tests conducted to evidence the system has been installed successfully 4 USER ACCEPTANCE TESTING User acceptance testing must be carried out by the end users of the system being validated with the aim that the system meets the user requirements and specification This should be undertaken prior to a system moving from a development environment to a production environment The Chief Investigator or nominated delegated authority is responsible for user acceptance testing 4 1
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