STANDARD OPERATING PROCEDURE Title Reference Number Study Management and Handover SOP-RES-012 Version Number 3 Issue Date 19 th April 2017 Effective Date 2 nd June 2017 Review Date 2 nd June 2019 Author(s) Reviewer(s) Melanie Boulter, QA Auditor Rachelle Sherman, Research Project Manager Authorisation (Original signatures are retained by Research & Innovation) Dr Steve Ryder Director of Research & Innovation Dr Stephen Fowlie Medical Director 21 st March 2017 16 th March 2017 USERS OF THIS STANDARD OPERATING PROCEDURE MUST REFER TO WWW.NUHRISE.ORG TO ENSURE THE MOST CURRENT VERSION IS BEING USED
Page 2 of 7 1. Document History Version Number Issue Date Reason for Change 1 30 th May 2014 Original SOP. Replaces SOP-39. Update following requirement for additional 2 08 th Dec 2016 information. Refer to Corrective and Preventive Action CA1502. 2 01 st Mar 2017 Clarity on the submission to regulatory authorities regarding change in Investigator
Page 3 of 7 2. Introduction It is a regulatory requirement that the sponsor of a clinical study maintains systems to ensure that studies are documented and data generated, recorded and reported in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirements. The Chief Investigator (CI), acting on behalf of Nottingham University Hospitals NHS Trust (NUH) as sponsor, is accountable for the conduct of research and ensuring that each member of the research team understands and is capable of undertaking their role(s). 3. Purpose and Scope The purpose of this standard operating procedure (SOP) is to outline the process to be followed by the NUH Research and Innovation (R&I) Research Project Manager (RPM) in managing, co-ordinating, overseeing and handing over (when necessary) the conduct of any clinical study for which NUH is responsible for from start-up through to close-out of a study. This SOP applies to NUH research staff and all studies that NUH are acting as sponsor for. 4. Delegation of Responsibilities Sponsor (fulfilled by the R&I department on behalf of NUH as sponsor) Where NUH is acting as sponsor, the Sponsor Agreement document defining the delegation of responsibilities between the two parties will be signed and agreed between the CI/Principal Investigator (PI) and the Sponsor. Research Project Manager (RPM) Responsible for Sponsor oversight and study management duties. The RPM must ensure when necessary the study is handed over to a new RPM according to this procedure, and complete a Project Manager Handover Record (TAFR01203) for the study. Chief Investigator/Principle Investigator Has overall responsibility for the conduct of the study; however, study duties may be delegated to the appropriately qualified staff. Maintains the Key Contacts for a study. Contact details for key study personal should be recorded and maintained throughout the study. A Key Contacts List template is available for this (TAFR01201).
Page 4 of 7 Maintains the Delegation Log for their site. A Delegation Log template is available for this (TAFR01202). Research Team Responsibilities can be delegated to other appropriately qualified members of the research team by the CI/PI, defined and recorded in the Delegation Log (TAFR01202). 5. Definitions CI CTIMPs CV GCP ICH ISF MHRA NUH PI REC R&I RPM SOP TMF Chief Investigator Clinical Trial of an Investigational Medicinal Product Curriculum Vitae Good Clinical Practice International Conference on Harmonisation Investigator Site File Medicines and Healthcare products Regulatory Agency Nottingham University Hospitals NHS Trust Principal Investigator Regional Ethics Committee Research and Innovation Research Project Manager Standard Operating Procedure Trial Master File 6. Procedure 6.1 Key Contacts List Creation and Maintenance For all NUH sponsored studies the CI/PI, or delegated study team member as appropriate, will ensure that key study contacts are outlined on the Key Contacts List (TAFR01201). Key contacts will be maintained by CI/PI throughout the lifecycle of the study and updated with any changes to key study contacts and filed at the front of the investigator site file (ISF)/trial master file (TMF). Each time the study Key Contacts List (TAFR01201) is amended, the sponsor should be notified and a copy should be forwarded to the study RPM to file in the sponsor s TMF.
Page 5 of 7 Note: changes to some study personnel may constitute a substantial amendment; therefore the Sponsor should be consulted prior to personnel changes (see section 6.2.1). 6.2 Delegation of Duties and Log Maintenance All those involved in research have a duty to ensure that they and those they manage are appropriately qualified, both by education and experience, for the role that they play in relation to any research. They must be aware of, and have ready access to sources of information and support in undertaking that role (refer to SOP-QMS-007 Training and Development). The PI has a responsibility to ensure, prior to the delegation of a study duty, that the study personnel concerned has a good knowledge and understanding of the study protocol (and investigational medicinal product, where applicable) and are competent to undertake the delegated task. The PI must provide appropriate training or provide access to appropriate training for delegated duties. The PI will ensure the appropriateness of the personnel undertaking the duties, by ensuring that up to date Curriculum Vitae s (CVs) of all personnel reflect requisite skills and education. The CVs of staff involved in research (e.g. research nurses, study coordinators, medical staff, research associates and study administrators) must be filed in the ISF. The Clinical Trial Regulations apply to clinical trials of investigational medicinal product (CTIMPs) and make it a statutory requirement to observe the principles set out in the ICH-GCP guidelines. All CIs/PIs and other research personnel involved in the conduct of studies at NUH must complete an appropriate level of ICH-GCP training, commensurate with their involvement in the study. For research personnel engaged in non CTIMP projects, it is not a legal requirement to complete ICH-GCP training. However the Trust recommends that this training is completed by research staff as the principles are applicable to all forms of research. For research personnel engaged in clinical investigations of medical devices (CMDs) they should also receive appropriate ISO 14155 training. The PI must complete the Delegation Log (TAFR01202) for each study which is kept in the ISF; it should identify all the suitably qualified persons to whom the PI has delegated significant study related duties. A copy of the Delegation Log should be sent to the Sponsor on request, or may be collected from site during monitoring. All personnel accepting a delegated duty are required to sign and initial against each duty identified on the Delegation log.
Page 6 of 7 The PI must sign and date to validate all entries on the Delegation Log. The PI are responsible for updating and amending the Delegation Log if delegated duties or personnel change during a course of study. 6.2.1 Change of CI/PI For all studies where NUH is sponsor, the NUH R&I office must be notified whenever there is a change of CI or PI in all circumstances. It is recommended a formal handover is arranged between CI/PI at point of changeover to discuss any issues relating to the conduct of the research including, for example, any trends in adverse events. For CTIMPs, a change of CI/PI is regarded as a substantial amendment which must be submitted to the Research Ethics Committee (REC) for approval (refer to SOP-RES-024 Amendments to Active Research Studies). A change in CI/PI is not required to be submitted to the Medicines and Healthcare Regulatory Agency (MHRA) as a substantial amendment, but should be highlighted along with all associated documentation regarding the change, with a subsequent substantial amendment (should there be one). 6.2.2 Changes in Research Team Members A formal handover should take place between the incoming and outgoing Research Team Members to discuss interventional procedures set out in the protocol, any specific trends or concerns. The CI or PI as appropriate, are responsible for ensuring the outgoing team member updates the duration to field on the delegation log with date their involvement upon the study ceased and for ensuring the incoming new study team member concerned has a good knowledge and understanding of the study protocol (and investigational product, where applicable) and are competent to undertake the delegated task, that they are added to the Delegation Log and their entry validated by the Investigator. 6.2.3 Changes in NUH Research Project Managers Changes to the Sponsor representative/study oversight manager (i.e. RPM) the Project Manager Handover Record (TAFR01203) must be used to document the transfer of study management responsibilities.
Page 7 of 7 The Project Manager Handover Record (TAFR01203) must be completed and signed by both RPMs. The HRC must also sign and approve the Project Manager Handover Record (TAFR01203), once approved; the study management responsibilities are officially the responsibility of the new RPM. The signed Project Manager Handover Record (TAFR01203) must be retained within the study TMF. 7. References and Associated Documents Good Clinical Practice Guide, 2012 Research Governance Framework for Health and Social Care: Second Edition, 2005 The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments International Conference on Harmonisation Guidelines for Good Clinical Practice E6 (R1) ISO 14155 Clinical Investigation of Medical Devices for Human Subjects TAFR01201 TAFR01202 TAFR01203 SOP-QMS-007 SOP-RES-024 Key Contacts List Delegation Log Project Manager Handover Record Training and Development Amendments to Active Research Studies