NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

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1 SOP details SOP title: Protocol development SOP number: TM 010 SOP category: Trial Management Version number: 03 Version date: 16 December 2016 Effective date: 16 January 2017 Revision due date: 16 January 2020 NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP author details Author name: Author position: Author signature: Date: Jill Peacock Quality Assurance Manager This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. SOP authoriser details Authoriser name: Authoriser position: Authoriser signature: Date: Professor Mark Walker Interim Director, Newcastle Clinical Trials Unit This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. 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: TM 010 Version: 03 Version date: 16 DEC 2016 Page 1 of 6

2 SOP revision record Version number Date Reason for revision 01 1 March 2013 Document release th January 2014 Document revision December 2016 Move onto new template, inclusion of NCTU standard protocol template and update Table of Contents 1. BACKGROUND PURPOSE SCOPE ROLES & RESPONSIBILITES ACRONYMS PROCEDURE Protocol development team membership Protocol authorship Content and format of the protocol Protocol development and version control Protocol sign off Protocol amendments REVIEW AND MONITORING OF THIS DOCUMENT ASSOCIATED DOCUMENTS... 6 SOP NCTU: TM 010 Version: 03 Version date: 16 DEC 2016 Page 2 of 6

3 1. BACKGROUND The protocol is the key document in a study and describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study. The protocol is the responsibility of the research sponsor however the development of the protocol is frequently delegated to the Chief Investigator (CI). The CI may request the input of a multidisciplinary team of individuals to form a protocol development team to provide input into specific areas of the protocol according to the individual areas of expertise. 2. PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the process for generating a clinical study protocol. 3. SCOPE This SOP applies to all Newcastle Clinical Trials Unit (NCTU) personnel involved in the development of a study protocol, in particular trial management and database management personnel. The SOP must be followed when NCTU are responsible for inputting into the development of a study protocol. 4. ROLES & RESPONSIBILITES The senior trial manager and trial manager are responsible for ensuring that the appropriate NCTU protocol template is used. Trial management personnel may provide guidance on all trial management aspects of the study to ensure compliance with the appropriate regulatory requirements. Specific input will be required regarding safety reporting, study monitoring, data protection and participant confidentiality as well as the definition of end of study. Database management personnel are responsible for the provision of guidance regarding the handling of study data including appropriate methods of data collection, provision of data for analysis and the archiving of the study database. The study statistician(s) are responsible for the provision of guidance regarding the statistical aspects of the study including sample size, endpoints and analyses. The CI should retain final responsibility for the quality check of the protocol and consistency with other study documentation e.g. participant information sheet and informed consent form, Case Report Forms (CRF) etc. 5. ACRONYMS CI CRF NCTU Chief Investigator Case Report Form Newcastle Clinical Trials Unit SOP NCTU: TM 010 Version: 03 Version date: 16 DEC 2016 Page 3 of 6

4 PDF SOP TMF TMG Portable Document Format Standard Operating Procedure Trial Master File Trial Management Group 6. PROCEDURE 6.1 Protocol development team membership The size and constitution of the protocol development team will depend on the nature, complexity and size of the clinical study and the expertise of the team members. The team will comprise the CI and personnel representing other disciplines as appropriate (including but not limited to trial manager, statistician, health economist, qualitative researcher etc.). A representative of the Sponsor and other external personnel may be involved, as appropriate. 6.2 Protocol authorship The protocol development team shall select a lead author to be responsible for the writing and production of the protocol. This is usually the CI for the study. The lead author shall collate relevant study information from the protocol development team members and present such information in the agreed format. 6.3 Content and format of the protocol The content of the protocol will vary according to the nature, complexity and size of the clinical study. For some studies it may be appropriate to develop a protocol synopsis prior to full protocol development for the purposes of funding applications and feasibility assessments. Once the research idea has been established, the protocol development team shall develop a draft protocol synopsis for review and approval. The synopsis may contain some or all of the following information: brief rationale for the study primary and secondary endpoints participant population and proposed recruitment numbers treatment schedule. The application to the funder will usually serve as the protocol synopsis. The protocol development team shall then use the approved synopsis as the basis for a full clinical study protocol. The NCTU protocol template must be used to ensure that all required sections are included in the protocol. Each protocol template is accompanied by a guidance document to describe the purpose and appropriate content for each section. The templates and associated guidance has consideration for the Health Research Authority guidance and SPIRIT recommendations therefore should not be amended unless within the remit of the template e.g. removal of the blinding section for open label studies. In the event that the NCTU protocol template cannot be used (e.g. where the funder or sponsor dictates the use of their SOP NCTU: TM 010 Version: 03 Version date: 16 DEC 2016 Page 4 of 6

5 own template) or there is a strong requirement to deviate from the template then this decision must be agreed by the Trial Management Group (TMG) and documented in the Trial Master File (TMF). 6.4 Protocol development and version control The protocol development team shall agree the content of the protocol through face to face meetings, conference calls and/or communications. The lead author shall collate comments and changes to the protocol throughout the development cycle. Comments on the protocol will normally be provided to the author as tracked changes within the document or via correspondence. The lead author will be responsible for collating reviewer comments and resolving any conflicting comments. The lead author shall incorporate the consolidated comments and the protocol shall be circulated for further review as necessary. When a consensus has been reached the protocol will be finalised and signed off. The protocol shall be stored on the assigned project specific drive thus ensuring the document is backed up on a regular basis. The file name structure should follow the requirements of the sponsor or those of NCTU if the sponsor does not have a specific naming convention. It is recommended that the protocol first submitted to the ethics committee/regulatory authority is documented as version 01 or 1.0. Therefore drafts prior to the first submission must be numbered as version 0.1, 0.2 etc. All draft versions must be retained in an electronic format, e.g. as Portable Document Format (PDF), in the specific trial folder in the NCTU shared drive. The lead author is responsible for document control, i.e. shall always be considered to have the latest version of the protocol document, and for implementing any changes to the document that may be required during the development process. Further information on document control is included in NCTU SOP GE Protocol sign off When finalised, the protocol must be signed off by a representative of the sponsor to demonstrate the sponsor authorisation of the protocol and the CI as confirmation of their agreement to comply with the protocol. The NCTU protocol template requires that the following key members of the protocol development team sign the protocol: Senior or Trial Statistician Trial Manager Database Manager Additional key members of the protocol development team may also sign the protocol (e.g. the senior trial manager, health economist etc.) as negotiated and agreed by the TMG. 6.6 Protocol amendments It is sometimes necessary to amend the protocol after finalisation. A protocol amendment may be required following regulatory or ethical review or if information or study procedures contained within the protocol change. Any amendments to the clinical trial protocol SOP NCTU: TM 010 Version: 03 Version date: 16 DEC 2016 Page 5 of 6

6 following sign off shall be incorporated into the protocol by the lead author, or other agreed member of the protocol development team. All changes to the protocol must be documented either as tracked changes within a new version of the protocol or tabulated in a separate document. The amended protocol shall be reviewed and signed off as described above. The current version of the protocol and all superseded versions shall be filed in the TMF. 7. REVIEW AND MONITORING OF THIS DOCUMENT This SOP will be reviewed every three 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 by the senior trial managers working on individual studies. It will also be monitored by the Quality Assurance Manager through the annual internal audit schedule. 8. ASSOCIATED DOCUMENTS NCTU SOP GE 003 Document Control NCTU Protocol Templates NCTU Protocol Template Guidance documents SOP NCTU: TM 010 Version: 03 Version date: 16 DEC 2016 Page 6 of 6