Title: Definition of Responsibilities

Transcription

1 Title: Definition of Responsibilities SOP Number and Version: 2, V1 Effective Date: 26/09/2014 Review Date: 26/09/2017 Please check this is the latest version of the SOP on the Joint Research Office website: Author: Name: Shivali Trivedi Position: IT/Portfolio Coordinator & QA Manager (Cancer Clinical Trials Unit) Signature Date Approved by: Name: Suzanne Binks Position: Quality Assurance Coordinator Signature Date Authorised by: Name: Rajinder Sidhu Position: Deputy Director of Research Support Centre Signature Date Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 1 of 8

2 Revision Chronology: Version Number: Effective date: Reason for change: Author: 1 26/09/2014 First version includes UCLH standardisation. Shivali Trivedi ACRONYMS Co-I CTA CTP DM GCP ICH IMP LRN QA R&D RN SOPs SSI Co-Investigator Clinical Trials Assistant Clinical Trials Practitioner Data Manager Good Clinical Practice International Conference on Harmonisation Investigational Medicinal Products Lead Research Nurse Principal Investigator Quality Assurance Research and Development Research Nurse Standard Operating Procedure Site Specific Information BACKGROUND At the participating site, the is responsible for the conduct of the clinical trial to ensure the safety of participants and the reliability and robustness of the data generated. The as leader of the research team may delegate his/her duties. The site delegation log is an essential clinical trial document to record the responsibilities of the research team authorised by the. It is used as evidence to demonstrate how individuals are assigned tasks appropriate to their education, training and experience. The SSI form section 23 includes the declaration as part of the NHS permission (R&D approval) process. By providing an e-authorisation for the declaration, the agrees to abide by the responsibilities stated. (Appendix 3) PURPOSE To ensure that members of the research team understand the importance of the allocation of responsibilities and to clarify boundaries of responsibility for the effective management and conduct of the clinical trial. PROCEDURE Who? The study staff members involved in clinical trials include, but are not limited to, the following: Principal Investigator () Co-Investigators (Co-I) Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 2 of 8

3 Specialist Registrars (SpR) Lead Research Nurse (LRN) Research Nurse (RN) Clinical Trials Practitioner (CTP) Data Manager (DM) Clinical Trials Administrator (CTA) Additional Study Staff: Clinicians, Specialist Nurses, Pharmacists, Laboratory staff, Other support staff (e.g. Radiology) Actions (When? How?) 1 Responsibilities of the Principal Investigator () Responsible persons (Who?) The is ultimately responsible for all trial activity at the trial site. The should maintain a list of appropriately qualified persons to whom they have delegated significant trial-related duties and ensure that all persons assisting with the trial are appropriately qualified, experienced and adequately informed about the protocol, their trial-related duties, and the IMPs. 2 Study Delegation Log The must keep a record of the delegation of clinical trial duties as per the Sponsor s requirements through a Delegation Log (see template in Appendix 1). The may delegate duties to key study staff as outlined in Appendix 2. 3 Signing the Delegation Log Key study staff members are responsible for signing the study Delegation Log prior to working on the study to confirm that they are delegated tasks appropriately. The should countersign the delegation log prior to an individual commencing 4 Additional Staff Where applicable additional staff associated with, but not directly involved in the research trial should also take responsibility for signing the study Delegation Log to confirm that they have delegated tasks appropriately. Additional study staff The should countersign the delegation log prior to an individual commencing Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 3 of 8

4 5 Evidence of Qualification and Training A delegated individual (e.g. Data Manager) may be assigned the responsibility of ensuring the study Delegation Log is kept updated with staff changes and maintain records of training with current study staff CVs & GCP Certificates (as further evidence of qualifications & training). 6 Pre-Study Phase Delegated individual During the pre-study phase, the & delegated study staff responsible for the clinical trial should discuss and agree on the study requirements (and with the Sponsor, if appropriate), ensuring all necessary procedures and assessments are understood. All protocol requirements will be identified and delegation of responsibilities agreed prior to commencing recruitment. Individual trial related duties should be defined, established, agreed and recorded on the study Delegation Log. As new staff members join the study team, trial related duties and functions should be defined, established, agreed and allocated prior to the individual commencing work on the study. During the R&D trial submission process, the acknowledges their study responsibilities by signing the declaration on the trial s SSI form. Study Staff Research Units at UCLH may also ensure their study s sign other documents to allow oversight over their respective trials (e.g. The Cancer Clinical Trials Unit (CCTU) requires that their study s read and sign a Responsibilities Agreement Form and re-sign every 2-years. This form serves as a reminder of duties and responsibilities it is not trial specific and is stored centrally with the CCTU CTA). 7 Open Study Phase During the open-study phase, the is responsible for the medical care and supervision of patients on trial, as well as the overall responsibility for the study at the site. The & delegated study staff responsible for the clinical trial should ensure they are observing the study protocol requirements (e.g. Informed consent, timely SAE reporting) and adhering to their individual responsibilities, as defined on the study delegation log. Any new staff members working on the trial are responsible for signing the study Delegation Log prior to working on the study to confirm that they are delegated tasks appropriately. The should countersign the delegation log prior to an individual commencing Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 4 of 8

5 8 Study Closure Phase During the study closure phase, the has overall responsibility for the study at the site. The & delegated study staff responsible for the clinical trial should ensure they are observing the study closure requirements as per the study protocol & UCLH Study Closure SOP and adhering to their individual responsibilities, as defined on the study delegation log. Any new staff members working on the trial are responsible for signing the study Delegation Log prior to working on the study to confirm that they are delegated tasks appropriately. The should countersign the delegation log prior to an individual commencing 9 Post-Study Closure Phase During the post-study closure phase, the has overall responsibility for the study at the site. During the post-study closure phase, the & delegated study staff responsible for the clinical trial should ensure they are following the study protocol & UCLH Archiving SOP and adhering to their individual responsibilities, as defined on the study delegation log. Any new staff members working on the trial are responsible for signing the study Delegation Log prior to working on the study to confirm that they are delegated tasks appropriately. The should countersign the delegation log prior to an individual commencing REFERENCES ICH GCP E6(R1) Guideline.pdf Research Governance Framework for Health and Social Care 2005 (2 nd Edition) UCLH SOP9: Study Close Down UCLH SOP10: Archiving of Investigator Site File & Pharmacy Site File (if applicable) APPENDICES Appendix 1 Template: Delegation Log Appendix 2 Responsibilities of Site Staff Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 5 of 8

6 APPENDIX 1: STUDY DELEGATION LOG Protocol Title/name: Principal Investigator: Protocol No: Site/site no: Name Initials Job Description Signature Responsibilities Date started work on Trial Date finished on Trial Authorised by & Date * Key: 1 Overall responsibility for study at site 2 Ethics 3 Screening of patients 4 Randomisation 5 Obtaining Informed Consent 6 Patient s assessments & medical care 7 Prescriptions 8 Administration of investigational product 9 Reporting of Adverse Events & Serious Adverse Events 10 CRF completion & data queries 11 Maintain essential documents & study site file 12 Drug receipt, dispensing & accountability 13 Maintain Pharmacy File 14 Storage of investigational product 15 Monitoring visit support 16 Archiving 17 Other (specify): Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 6 of 8

7 APPENDIX 2: APPROVED RESPONSIBILITIES OF SITE STAFF The list below is to serve as a guide of approved trial responsibilities for study staff members. Please note: Additional responsibilities (not listed in each category) may be delegated if staff are appropriately qualified, trained and authorised on the study delegation log by the. Chief/Principal Investigator Overall responsibility for study at site Medical care and supervision of patients Delegation of study related duties appropriately Ensure all staff delegated to work on trial are: o Qualified by education, training & experience o Thoroughly familiar with study protocol and the investigational product(s) o Aware of, and compliant with GCP and any applicable regulatory requirements pertaining to clinical trial conduct o Aware of relevant SOPs Familiarity with Investigator Brochure Recruitment Strategy Screening Informed Consent Completion of Informed Consent Form Randomisation Administration of study drug Collection of trial related blood samples Completion and return of CRF s and providing responses to data queries overall trial data oversight Prescriptions Documentation of Adverse Events (AE) and signing AE forms Timely Serious Adverse Events (SAE) Reporting and signing of SAE forms Initiation of new trial personnel Ethics committee approval/communications re: amendments Negotiation and completion of the financial agreement Indemnity, compensation and insurance Investigational product accountability and monitoring of compliance Available for audit and inspections Archiving Others, as locally applicable Co-Investigator (including Consultants & Clinicians in training) Screening of patients for eligibility Medical care of patients Informed consent Completion of Informed Consent Form Randomisation Prescriptions Administration of study drug Responsible for collection of trial specific blood samples Completion and return of CRF s and providing responses to data queries Documentation of Adverse Events (AE) and signing AE forms Timely Serious Adverse Events (SAE) Reporting and signing of SAE forms Ethics committee obligations Available for audit and inspections Archiving Others, as locally applicable Research Nurse (RN) & Clinical Trials Practitioner (CTP) Screening of patients for eligibility Informed Consent (information giving only, unless protocol and necessary regulatory authority permits the RN or CTP to obtaining written informed consent) Randomisation Administration of study drug Responsible for collection of trial specific blood samples Documentation of Adverse Events in source data Completion and return of CRF s and data queries Support monitoring visits, audits and inspections Preparation of SAE reports for medical input and causality assessment Notifying patient s GP of their involvement in the study Organisation of clinic appointments and investigations as per protocol requirements Ensuring that the patient is aware of who to contact should they experience problems or side effects between clinic visits As appropriate, collect study IMP from pharmacy and provide to patient Others, as locally applicable Data Manager Screening of patients for eligibility Randomisation Informed Consent (only if delegated this responsibility by study as per Informed Consent SOP) Data entry Completion and return of CRF s and data queries Support monitoring visits, audits and inspections Preparation of SAE reports for medical input and causality assessment Investigator/Study site file set up and maintenance Maintenance of trial logs and essential documents Preparations of paperwork for Ethics committee/r&d General Assistance with coordination of trial follow-up procedures Shipment of trial related samples Archiving Others, as locally applicable Pharmacist Acknowledge receipt of trial supplies Drug accountability and monitoring of compliance Dispensing of investigational product to patients Complete dispensing log Maintain Pharmacy Site File Monitor storage of Investigational Product Others, as locally applicable Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 7 of 8

8 Appendix 3 SSI Section 23 Principal Investigator Declaration Please note: The current declaration form will be found on IRAS when authorising a trial SSI form. 23. Authorisations required prior to R&D approval The local research team are responsible for contacting the local NHS R&D office about the research project. Where the research project is proposed to be coordinated centrally and therefore there is no local research team, it is the responsibility of the central research team to instigate this contact with local R&D. NHS R&D offices can offer advice and support on the setup of a research project at their organisation, including information on local arrangements for support services relevant to the project. These support services may include clinical supervisors, line managers, service managers, support department managers, pharmacy, data protection officers or finance managers depending on the nature of the research. Obtaining the necessary support service authorisations is not a prerequisite to submission of an application for NHS research permission, but all appropriate authorisations must be in place before NHS research permission will be granted. Processes for obtaining authorisations will be subject to local arrangements, but the minimum expectation is that the local R&D office has been contacted to notify it of the proposed research project and to discuss the project s needs prior to submission of the application for NHS research permission via IRAS. Failure to engage with local NHS R&D offices prior to submission may lead to unnecessary delays in the process of this application for NHS research permissions. Declaration: I confirm that the relevant NHS organisation R&D office has been contacted to discuss the needs of the project and local arrangements for support services. I understand that failure to engage with the local NHS R&D office before submission of this application may result in unnecessary delays in obtaining NHS research permission for this project. Declaration by Principal Investigator or Local Collaborator 1. The information in this form is accurate to the best of my knowledge and I take full responsibility for it. 2. I undertake to abide by the ethical principles underpinning the World Medical Association's Declaration of Helsinki and relevant good practice guidelines in the conduct of research. 3. If the research is approved by the main REC and NHS organisation, I undertake to adhere to the study protocol, the terms of the application of which the main REC has given a favourable opinion and the conditions requested by the NHS organisation, and to inform the NHS organisation within local timelines of any subsequent amendments to the protocol. 4. If the research is approved, I undertake to abide by the principles of the Research Governance Framework for Health and Social Care. 5. I am aware of my responsibility to be up to date and comply with the requirements of the law and relevant guidelines relating to the conduct of research. 6. I undertake to disclose any conflicts of interest that may arise during the course of this research, and take responsibility for ensuring that all staff involved in the research are aware of their responsibilities to disclose conflicts of interest. 7. I understand and agree that study files, documents, research records and data may be subject to inspection by the NHS organisation, the sponsor or an independent body for monitoring, audit and inspection purposes. 8. I take responsibility for ensuring that staff involved in the research at this site hold appropriate contracts for the duration of the research, are familiar with the Research Governance Framework, the NHS organisation's Data Protection Policy and all other relevant policies and guidelines, and are appropriately trained and experienced. 9. I undertake to complete any progress and/or final reports as requested by the NHS organisation and understand that continuation of permission to conduct research within the NHS organisation is dependent on satisfactory completion of such reports. 10. I undertake to maintain a project file for this research in accordance with the NHS organisation's policy. 11. I take responsibility for ensuring that all serious adverse events are handled within the NHS organisation's policy for reporting and handling of adverse events. 12. I understand that information relating to this research, including the contact details on this application, will be held by the R&D office and may be held on national research information systems, and that this will be managed according to the principles established in the Data Protection Act I understand that the information contained in this application, any supporting documentation and all correspondence with the R&D office and/or the REC system relating to the application will be subject to the provisions of the Freedom of Information Acts and may be disclosed in response to requests made under the Acts except where statutory exemptions apply. Definition of Responsibilities, SOP 2, V1, 15/09/2014 Page 8 of 8