NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

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1 NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Risk Assessment of NCTU Studies SOP number: TM-020 SOP category: Trial Management Version number: 02 Version date: 16 May 2018 Effective date: 16 June 2018 Revision due date: 16 June 2021 SOP author details Author name: Author position: Author signature: Date: 16 May 2018 Joan Farrington Deputy QA Manager This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. SOP authoriser details Authoriser name: Emily Swinburne Authoriser position: QA Manager Authoriser signature: This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. Date: 16 May 2018 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-020 Version: 02 Version date: 16 May 2018 Page 1 of 5

2 SOP revision record Version number Date Reason for revision July 2017 Document release May 2018 Document updated to reflect the changes to the NCTU RACT process. Reference to the NCTU RACT guidance added and further information regarding the unit risk register. Table of Contents 1. BACKGROUND PURPOSE SCOPE ROLES & RESPONSIBILITES ACRONYMS PROCEDURE Risk assessment Risk Register Ongoing review of the RACT REVIEW AND MONITORING OF THIS DOCUMENT ASSOCIATED DOCUMENTS... 5 SOP NCTU: TM-020 Version: 02 Version date: 16 May 2018 Page 2 of 5

3 1. BACKGROUND Risk assessment is the systematic manner of identifying and assessing potential risks that may be associated with a clinical study. All studies are associated with a level of risk so it is important that potential hazards are identified at an early stage of study development in order that they can be monitored and appropriate mitigation strategies employed where necessary. It is key that the safety, rights and wellbeing of study participants along with the integrity of the study data are upheld at all times. The Newcastle Clinical Trials Unit (NCTU) risk assessment is used to inform other areas of study management, e.g. the monitoring strategy outlined in the study monitoring plan and the data management strategy in the database management plan, as well as any risks to the unit. 2. PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the process to be followed when compiling a study risk assessment within NCTU. 3. SCOPE This SOP applies to all studies managed by NCTU. The SOP is particularly pertinent to Trial Management and Database Management personnel however is applicable to any member involved in a study. 4. ROLES & RESPONSIBILITES The Trial Manager (TM) is responsible for instigating and leading the risk assessment process; forwarding a copy of the NCTU Risk Assessment Categorisation Tool (RACT) to the Quality Assurance (QA) team and sponsor and ensuring all final versions of the RACT are filed within the Trial Master File (TMF). The TM is also responsible for incorporating the risk mitigation strategies affecting study monitoring into the monitoring plan. The Senior Trial Manager (STM) is responsible for supporting the TM during the risk assessment process and escalating any high-risk studies to the Research Sponsor and NCTU Senior Management Team. The Database Manager (DBM) is responsible for inputting into mitigation strategies affecting the data management of a study and ensuring the Database Management Plan (DMP) incorporates the appropriate risk mitigation strategies. The Senior Management Team are responsible for reviewing all studies assessed as high risk. The QA team are responsible for providing guidance on risk assessment and appropriate risk mitigation strategies, and ensuring that the NCTU risk register is updated appropriately. 5. ACRONYMS DBM DMP Database Manager Database Management Plan SOP NCTU: TM-020 Version: 02 Version date: 16 May 2018 Page 3 of 5

4 GCP ICH NCTU QA RACT SOP STM TM TMF TMG Good Clinical Practice International Conference for Harmonisation Newcastle Clinical Trials Unit Quality Assurance Risk Assessment Categorisation Tool Standard Operating Procedures Senior Trial Manager Trial Manager Trial Master File Trial Management Group 6. PROCEDURE 6.1 Risk assessment The risk assessment should be instigated as early as possible during study design however, must be completed once a draft protocol is in place at the very latest and must be finalised before submission of the study for approval. This is to allow the outcome of the risk assessment and any risk adaptation strategies to be incorporated into the protocol and other study documents as appropriate e.g. monitoring plan. The TM is responsible for leading on the risk assessment, supported by the STM, however the entire Trial Management Group (TMG) must input into the risk assessment. It is recommended that the initial risk assessment is performed at a dedicated TMG session. The NCTU RACT must be used and modified as appropriate to the study e.g. the section on blinding will not be applicable to non-blinded studies. The RACT contains risk categories e.g. safety, study design etc. with each category broken down into hazards. The pre-populated hazards are not an exhaustive list and additional study-specific hazards should be added as necessary. For each hazard, an assessment must be conducted of the following: Impact the potential impact the hazard would have to participant safety and/or data integrity graded as low, medium or high. Probability the likelihood of the hazard occurring graded as low, medium or high. Visibility how easy is it to detect the resulting adverse effects of the hazard graded as easy to detect, detectable with effort and hard to detect. All hazards should be scored based upon the risk prior to the implementation of any mitigation/management strategies. Mitigation strategies must be documented as to how the risk of each hazard will be managed. It may be that the risk is low or justifiable when considering the benefit and in this case a comment should be added to justify this. For further information on how to complete the RACT tool, refer to the RACT guidance documents. Once the RACT has been completed the study will be assigned a category of low, medium or high risk. The TM should send a copy of the completed RACT to the QA Manager for review and comment. The TM must ensure that a copy of the final NCTU RACT and any additional risk assessment tools as appropriate are provided to the sponsor and filed within the TMF. SOP NCTU: TM-020 Version: 02 Version date: 16 May 2018 Page 4 of 5

5 Where a study is classed as high risk, the STM must bring this to the attention of both the Research Sponsor and the NCTU Senior Management Team for further discussion. 6.2 Risk Register It is the responsibility of the QA Team to ensure that the NCTU Risk Register is kept up to date. The risk register is a risk management tool acting as a repository for risk identified from individual trial RACTs, that impact on the unit. The risk register provides information on: Risk identified Risk category Probability Impact Mitigating actions 6.3 Ongoing review of the RACT The RACT and any other applicable risk assessment tools should be reviewed at least on an annual basis by the TMG, however, a review should also be implemented in response to significant changes in risk on the study e.g. serious breach, repeated deviations within the same area, data quality problems. All review discussions must be documented and stored in the TMF. Where the scoring of a hazard has changed e.g. due to successful implementation of mitigation strategies or in response to unforeseen issues, the RACT and any other applicable risk assessment tools must be updated along with any associated documents e.g. monitoring plan or DMP. All updates must be completed in accordance with NCTU SOP GE-003 Document Control and filed within 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/guidance or significant revision to the process contained in the SOP. The use of this SOP will be monitored by Senior Trial Manager for the study and by the QA team through the internal audit cycle. 8. ASSOCIATED DOCUMENTS NCTU Risk Assessment Categorisation Tool NCTU SOP GE-003 Document Control NCTU RACT Guidance Document NCTU Data Monitoring Plan Template NCTU Data Management Plan Template SOP NCTU: TM-020 Version: 02 Version date: 16 May 2018 Page 5 of 5