R&D Administration Manager. Research and Development. Research and Development

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1 Document Title: Roles and Responsibilities for the Conduct of Research Studies and Clinical including CTIMPs (Clinical of Investigational Medicinal Products) Document Number: SOP055 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager, Research Officers R&D Administration Manager Research and Development Research and Development NHS Staff Trust-Wide Review due: April 2016 THIS IS A CONTROLLED DOCUMENT Whilst this document may be printed, the electronic version maintained on the Trust s Intranet is the controlled copy. Any printed copies of this document are not controlled. Papworth Hospital NHS Foundation Trust. Not to be reproduced without written permission. Key Points of this Document This document sets out the procedures to be followed by all Papworth Staff who Conduct Research Studies and Clinical at Papworth Hospital NHS Foundation Trust It aims to provide clear guidance on the Conduct Research Studies and Clinical to ensure compliance with the Trust s policies. Page 1 of 14

2 1 Purpose and Content 1.1 This document defines Roles and Responsibilities for the conduct of Research Studies and Clinical including CTIMPs (Clinical of Investigational Medicinal Products) at Papworth Hospital NHS Foundation Trust. 1.2 The document clarifies the Roles and Responsibilities of the Sponsor, Chief investigator, Principal investigator and other research staff as described in Good Clinical Practice (GCP: a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected ). 1.3 The document aims to provide clear guidance on who takes overall responsibility for each study process. It also provides information on the Standard Operating Procedures that should be consulted at each stage of a research study. 2 Roles & Responsibilities 2.1 The conduct of clinical research studies is the responsibility of the Sponsor, the Chief investigator and one Principal investigator at each participating site. The duties that need to be completed as part of a clinical research study can be delegated but not the responsibility The Sponsor is an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial The Chief Investigator (CI) is the authorised health care professional who takes primary responsibility for the conduct of the trial. There is only one Chief Investigator per Member State The Principal Investigator (PI) is the person who takes responsibility for the initiation and conduct of the study at site. There should be one Principal Investigator at each site participating in a research study. For a single site study the Chief investigator may also take on the role of Principal investigator. 2.2 The Sponsor, Chief investigator and Principal investigator may delegate certain duties but the responsibility for ensuring that these duties are carried out remains with themselves. See SOP030 Roles and Responsibilities/Delegation Log. Page 2 of 14

3 3 Policy 3.1 This SOP is mandatory and, as per the Trust s Information Governance and Records Management framework, non-compliance with may result in disciplinary procedures. 4 Procedure 4.1 Overview At Papworth Hospital NHS Trust the roles and responsibilities for the management of research studies are listed in the appropriate SOPs for each study process. A guide to these processes and the related SOPs are detailed in the following appendices: Appendix 1: Sponsor Responsibilities. Appendix 2: Responsibilities of the Chief Investigator. Appendix 3: Responsibilities of the Principal Investigator. Appendix 4: Responsibilities of all research staff. In brief, the responsibilities are divided as follows: The Sponsor takes responsibility for the initiation, management and/or financing of a clinical trial and can delegate responsibility of CTIMPs. The sponsor must ensure that: For all research A favourable opinion from the Research Ethics Committee has been obtained Protocol amendments are correctly processed Suitable indemnity/insurance arrangements are in place The study is conducted according to the principles of GCP The Research Ethics Committee is notified when the study has ended. This action can be delegated. There are sufficient resources available to complete the study. For CTIMPs A EudraCT Number is obtained (European Clinical Database) Competent Authority Authorisation (MHRA) is obtained by the Chief Investigator Pharmacovigilance (Adverse Event) reporting requirements and time frames are adhered to EudraCT and the MHRA are notified when the trial has ended The Chief Investigator (CI) is the authorised health care professional who takes primary responsibility for the conduct of the trial. This includes: Page 3 of 14

4 the ethics application the MHRA application (for CTIMPs) and duties delegated by the Sponsor The Principal Investigator (PI) is the person who takes responsibility for the initiation and conduct of the study at site. This includes: R&D application (submission of the site specific information) Delegation of duties Sign off to say staff are competent to work on a study at site and ensuring that they have had GCP and appropriate study related training Safety reporting Oversight and management of Investigational Medicinal Product (IMP) All Research Staff are responsible for: Ensuring the safety and well being of participants Fulfilling the duties they have signed up to on the delegation log Completing GCP and appropriate study specific training Alerting the Principal investigator, and if necessary the sponsor, of any concerns that they may have regarding the conduct of the study 5 Risk Management / Liability / Monitoring & Audit 5.1 The Unit will ensure that this SOP and any future changes to this document are adequately disseminated. 5.2 The Unit will monitor adherence to this SOP via the routine audit and monitoring of individual clinical trials and the Trust s auditors will monitor this SOP as part of their audit of Research Governance. From time to time, the SOP may also be inspected by external regulator agencies (e.g. Care Quality Commission, Medicines and Healthcare Regulatory Agency). 5.3 In exceptional circumstances it might be necessary to deviate from this SOP for which the written approval of the Senior R&D Manager should be gained before any action is taken. SOP deviations should be recorded including details of alternative procedures followed and filed in the Investigator and Sponsor Master File. 5.4 The Research and Development Directorate is responsible for the ratification of this procedure. Page 4 of 14

5 APPENDIX 1 SPONSOR DUTIES Ethics Approval of Research Studies SOP005 Adverse Event Reporting - SOP012 Statistical Input into Papworth Sponsored Clinical : Policy and Procedure SOP017 Contract Negotiation and Review SOP024 Statistical Analysis Plans SOP The Sponsor is responsible for ensuring that the study design meets the required standards, and that the study can be conducted and reported appropriately. 4.1 The Sponsor takes primary responsibility for ensuring that the design of the study meets the appropriate standards and that suitable arrangements are in place for the conduct and reporting of the study Scientific Review It is the responsibility of the Sponsor of the study to ensure that this review is thorough and ensures the quality of the study being proposed The Sponsor is responsible for ensuring that actions that necessitate a substantial amendment to the research protocol will be approved by ethical, R&D and MHRA (for IMP and non CE marked devices) through the normal routes. See SOP037 Amendments Post Trust Approval for further information. This duty may be delegated to the Chief Investigator The Sponsor is responsible for ensuring that at the conclusion of the study all adverse events / reactions / device effects, recorded during a study are subject to statistical analysis and that analysis and subsequent conclusions included in the final study report. 2.3 The Sponsor, or their delegated representative, is responsible for ensuring the quality of their trial through the use of appropriately qualified statisticians in the trial design, interim and final analysis Copies of the contract, clinical trials agreement/statement of agreement (including financial agreement) between the Trust and the study sponsor must be sent to the R&D Admin Manager for review. A copy of the protocol must also be provided to be reviewed alongside the CTA All externally funded commercial research activity are subject to a one-off non-refundable set-up fee, which shall be paid by the Sponsor to R&D on sign off of the CTA for the proposed study. Site Recruitment and Initiation for Papworth Sponsored Studies SOP015 Investigator File SOP010 Monitoring Papworth Sponsored Studies SOP The Sponsor, or their designee, is responsible for the selection of, and recruitment of, additional sites. 2.3 The Sponsor of a research study is responsible for providing each site with the correct study related material. 2.3 The Sponsor takes responsibility for the monitoring of their study and may delegate the task to an appropriately trained member of the study team (the monitor). 4 The Sponsor should determine the appropriate extent and nature of monitoring based on the objective, purpose, design and complexity of the trial. The monitoring arrangements will be assessed prior to the start of the trial and will be agreed at RGPAS Page 5 of 14

6 Preparation of Development Safety Update Reports SOP062 Archiving SOP011 as part of the local approvals process. 2.3 The trial sponsor is responsible for the preparation, content and submission of the DSUR although they may delegate the actual task to a competent member of the study team. 2.3 The Sponsor of a research study is responsible for arranging the archiving of the study related material. The actual procedure may be delegated to a responsible member of the site s research team Clinical trial documentation can be archived by either the Investigator or the Sponsor as defined in the contract. Page 6 of 14

7 APPENDIX 2: THE RESPONSIBILITIES OF THE CHIEF INVESTIGATOR STUDY DEVELOPMENT PHASE Chief Investigator Research Protocol Design for Papworth Sponsored Studies - SOP019 Statistical Input into Papworth Sponsored Clinical : Policy and Procedure SOP017 Patient Information Sheets and Consent Forms: Development, Implementation and Dissemination to the Research Team- SOP020 Applying for Papworth Sponsorship SOP048 Ethics Approval of Research Studies SOP005 Gaining Regulatory Approval from the MHRA SOP014 Case Report Forms SOP054 Database Construction 5.1 The Protocol should be developed by a suitably experienced multi disciplinary project team commensurate with the nature, complexity and magnitude of the research including clinical procedures and risks The CI and project team can nominate clinically important and/or relevant primary and secondary outcome measures, but the statistician should establish the feasibility of these including variability for sample size calculations and ease of data collection via case report forms. 2.3 The CI is responsible for the production of patient information documents ensuring that these have been approved by the appropriate regulatory bodies prior to their use. 2.3 The CI of a research study is responsible for ensuring that the study is sponsored and that all the relevant regulatory approvals have been obtained. The actual procedure of obtaining sponsorship may be delegated to a responsible member of the core research team The CI, or their delegate, makes the application for ethical approval of a study All applications must be made using the web based IRAS application form at It is strongly recommended that the CI attend the REC meeting to answer any queries raised by the Committee. 4.6 It is the responsibility of the CI to ensure that all PIs working on the study have a copy of the Ethics response letter and this should be stored in the Investigator/Site File. Trust Approval will not be given until all conditions are met and full Ethical Approval for a study has been obtained. Therefore, no clinical activities, including recruitment and patient selection, may be undertaken prior to this. 2.3 The CI, in conjunction with the Sponsor s representative, is responsible for applying for MHRA approval All applications must be made using the web based IRAS application form at For Papworth Sponsored CTIMPs the CI is responsible for ensuring that all documentation is submitted to R&D Enquiries as in section prior to submission to the MHRA. This could be after or concurrent with, the application for sponsorship (see SOP048: Applying for Papworth Sponsorship) The CI is responsible for ensuring that a copy of the MHRA approval letter is forwarded to the Research Governance Team in R&D via R&DEnquiries@Papworth.nhs.uk as it will be required for the Trust Approval of a study The CI is responsible for forwarding copies of any MHRA approval letters relating to substantial amendments to R&D as in section The CI is responsible for ensuring that reports to the MHRA must be sent with a covering letter and this letter should also be forwarded to R&D. 2.5 CRF design is the responsibility of the CI or delegate, but should involve other members of the team, including but not limited to: researchers, trial coordinators or managers, research nurses, data managers and statisticians. For medicinal trials, the CI must sign off the CRF validation form to show that they approve the final version of the CRF. Page 7 of 14

8 SOP057 Sponsor Files for Papworth Sponsored Studies SOP013 Site Recruitment and Initiation for Papworth Sponsored Studies SOP015 GCP Training for Research Staff SOP The CI is responsible for the set-up and updating of the sponsor file although these tasks may be delegated to a member of the study team The sponsor file should be set-up for the start of the study prior to recruitment of the first patient. The CI, or a designated member of the study team, will take responsibility for setting up the file. The file will be identified by the R&D code (P0XXXX) and a brief study title The CI or their designee must keep the Sponsor file up to date and make sure that the minimum documentation required by GCP guidelines is present. The file should be reviewed as a minimum at the start, during and upon completion of the study The CI is responsible for selecting appropriate investigators and institutions for a particular study although this task may be delegated to a member of the study team Each Principal Investigator must be qualified by education, training, and experience and must have adequate resources to properly conduct the study. This must be evidenced in the form of a current curriculum vitae (CV) or other documentation and stored in the trial master file The CI is responsible for site initiation and this may be delegated to a member of the research study team CIs of Papworth sponsored clinical trials are required to undertake an NIHR tutor-led GCP training, refresher course or equivalent, prior to, and within two years throughout the individual s involvement in the trial. STUDY CONDUCT Chief Investigator Patient Recruitment SOP031 Randomisation of Papworth Sponsored Clinical SOP018 Adverse Event Reporting - SOP012 Amendments Post-Trust Approval SOP The exact procedure for patient recruitment should be detailed in the study protocol A clinical trial must not commence until the study has TA and the randomisation schedule is finalised (as per Statistics Input in Clinical SOP017) Clinical trial staff involved in implementation of randomisation schedule should be given full training in the process for each research study. This training must be given by the Trial Manager or a designated team member The CI will keep the Sponsor, the REC and MHRA (if applicable) informed of any significant findings and recommendations by an independent Data Monitoring Committee (DMC), or equivalent, where one has been established for the trial The CI will inform all PIs of relevant information about SAEs/SADEs that could adversely affect the safety of subjects The CI will provide the main REC with copies of all reports and recommendations of any independent DMC established for a trial as part of the SUSAR/USADE expedited or periodic reporting For IMP/Medical Device studies, on request of the MHRA the CI will submit detailed records of all adverse events that have been reported. 2.3 The CI of a research study is responsible for initiating any amendments to a study and ensuring that all the relevant regulatory approvals have been obtained prior to its implementation. The actual procedure of applying for and implementing amendments may be delegated to a responsible member of the research team For Papworth sponsored studies the delegated member of the research team will coordinate the amendment application process For Trust sponsored studies all documents submitted to ethics should be provided to R&D. Handling of Protocol Non- 2.3 The CI/PI must ensure that they, and their study staff, comply with Page 8 of 14

9 Compliance and Regulatory Non-Compliance SOP050 Serious Breach of Protocol or GCP in CTIMPs SOP051 Change of Investigator SOP038 the requirements set out in section The CI of a CTIMP, a trial of a non-ce marked device, must ensure that they, and their staff, comply with the requirements set out in section The CI should notify a senior R&D manager and the Sponsor (if not Papworth) that they are leaving their post as soon as is possible so that alternative arrangements can be made. 2.3 The CI departing a research study may suggest an alternative Investigator to take their place, but it is the responsibility of the Sponsor (or their delegated representative) to appoint the new Investigator. STUDY CLOSE DOWN Chief Investigator Closing Down a Database including Lock & Unlock Procedures SOP059 Trial Closure and End of Trial Reporting SOP The Chief Investigator, or their designee, is responsible for informing the applicable regulatory authorities of the end of trial and submitting the necessary end of trial reports The Chief Investigator, or their designee, should inform the principal investigators at other sites, in writing, that the trial has closed. The Chief Investigator, or their designee, may need to visit sites to formally close the study. 4.3 It is the responsibility of the Chief Investigator to ensure the results of the study are analysed and reported within a reasonable timeframe. A summary of the final report on the research should be sent to the MHRA, main REC and R&D Unit within 12 months of the end of the project. The Investigator should make all necessary efforts to get the results reported in a peer reviewed journal. Page 9 of 14

10 APPENDIX 3: RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS STUDY DEVELOPMENT PHASE Principal Investigator Applying for Papworth Sponsorship SOP048 Contract Negotiation and Review SOP024 Investigator File SOP010 Roles and Responsibilities/Delegation Log SOP030 GCP Training for Research Staff - SOP049 Trust Approval and Research Governance SOP034 Assessment and Registration of Trust Risk Rating for Research Studies SOP The PI of a research study is responsible for ensuring that the study is sponsored and that all the relevant ethical and regulatory approvals have been obtained Papworth Hospital NHS Foundation Trust is the legal body with whom all contracts / agreements must be made. Principal Investigators must not enter into agreements with third parties Finalised contracts will be signed by the Clinical Director of Research and Development. In their absence contracts will be signed by the Deputy Clinical Director of Research and Development of the Medical Director. If the Clinical Director of R&D is the Investigator for the study or involved in the study conduct then the contract will be signed by the Deputy of R&D or the Medical Director. 2.3 The site file is the responsibility of the PI although the actual procedures involved may be delegated to a responsible member of the site s research team. 2.4 The details of the research team members who are involved in maintaining the site file should be recorded on the delegation log. 2.3 The Principal Investigator (PI) for each study within the Trust carries the primary responsibility for the conduct of the trial at Papworth and as such they should ensure that tasks are only delegated to those who are deemed sufficiently competent. 2.3 The PI is responsible for ensuring that they themselves and their research staff are trained in, and compliant with, GCP procedures as appropriate PIs of Papworth sponsored clinical trials are required to undertake an NIHR tutor-led GCP training, refresher course or equivalent, prior to, and within two years throughout the individual s involvement in the trial. 2.3 The PI, or their delegated personnel, are responsible for the submission of all the required information to the Research Governance Team, during the Trust Approval process A site specific information form (SSIF) must be submitted signed to R&D for all studies seeking trust approval. Investigators should contact the R&D department for assistance in obtaining all the necessary directorate approvals via: R&DEnquiries@Papworth.nhs.uk 2.3 Investigators, researchers and other relevant personnel must take account of the risks a study poses when designing research to be sponsored by Papworth and take steps to minimise or avoid such risks. STUDY CONDUCT Principal Investigator Patient Information Sheets and Consent Forms: Development, Implementation and Dissemination to the Research Team - SOP020 Patient Recruitment SOP The principal investigator is responsible for ensuring that the patient information sheet is disseminated to all the members of the research team. Copies should be placed in the study site file. Care should be taken to ensure that the most recent, approved version is disseminated for use. 2.3 The Principal Investigator (PI) for each study within the Trust carries the primary responsibility for the conduct of the trial at Papworth. They should be aware of the recruitment strategy and how recruitment is progressing. The Clinical Research Nurse or Trial Co-ordinator (CRN/CTC) and team members may be delegated to keep records of Page 10 of 14

11 Informed Consent SOP003 Randomisation of Papworth Sponsored Clinical SOP018 Study Data (CRF s and Source Data) SOP 047 Adverse Event Reporting - SOP012 Data Entry and Data Quality Control SOP053 Monitoring Papworth patient recruitment and a screening log. 2.3 The PI of a research study is responsible for ensuring that the informed consent of study participants is obtained. The actual procedure may be delegated to a responsible member of the site s research team who is deemed to be appropriately qualified by knowledge and training The responsibility for the delegation of taking informed consent lies with the PI Once randomised, participants should remain in the trial unless they specifically withdraw consent for continued follow-up. In no circumstances should a randomised participant be withdrawn by a clinician on the basis of that participant s treatment allocation. 2.3 The PI must ensure that if their research staff are recording or handling study data, that they are trained and compliant with GCP procedures. Staff entering data in CRFs must be listed on the study delegation log For studies that are governed by the MHRA authorisation all test reports (e.g. blood results, radiology reports, ECGs) must be signed and dated by the PI or designee in accordance with GCP. Any abnormalities must be noted and marked as either clinically significant or insignificant. Abnormal results should be recorded as an adverse event, depending upon their nature, and the appropriate action taken The investigator must ensure that the dignity, rights, safety and well being of research participants are given priority at all times and must take appropriate action to ensure the safety of all staff and participants in the study In the event of an adverse event/reaction (AEs) the investigator (or delegate) must review all documentation that is relevant to the event (e.g. patient notes, laboratory reports). The event and relevant comments must be recorded in the subject s medical notes (or source data) and reported to the Sponsor as documented in the protocol Investigators (or delegated persons) will provide follow-up information, each time new information is available using the study CRF provided or page 3 of the form entitled FRM007 Papworth SAE/SUSAR Reporting Form (available from the R&D intranet pages). This will be completed until the SAE/SADE has resolved or a decision for no further follow-up has been taken by the PI or delegated person Unless the protocol states otherwise and has exempted certain events from being recorded or escalated reporting, the Investigator (or delegate) is responsible for ensuring that all adverse event/reactions are recorded in detail on case report forms or equivalent so as to allow analysis at a later stage The Investigator (or delegate) will make an assessment of causality for all adverse event/reactions. This process must be clearly documented. This must be completed by medically qualified personnel The Investigator (or delegate) must ensure that Adverse Events and/or laboratory abnormalities identified in the protocol as critical to the evaluations of the safety of the study shall be reported to the Sponsor in accordance with the reporting requirements documented in the protocol The Investigator is responsible for notifying the Sponsor as soon as they become aware of a pregnancy The Investigator must obtain informed consent for follow-up of the pregnancy from the trial subject (or their partner in the case of male subjects). 2.3 The PI must ensure that if their research staff are recording or handling study data, that they are trained and compliant with GCP procedures. Staff entering data in CRFs must be listed on the study delegation log. 2.4 The PI must ensure that their research staff are cooperative and Page 11 of 14

12 Sponsored Studies SOP016 Amendments Post-Trust Approval SOP037 Handling of Protocol Non- Compliance and Regulatory Non-Compliance SOP050 Serious Breach of Protocol or GCP in CTIMPs SOP051 Change of Investigator SOP038 assist the monitor in both scheduling the monitoring visits and accessing the required documentation The PI should review and sign off the Data Query form, once all the queries have been resolved, and the completed monitoring report. 2.4 The PI of a research study is responsible for identifying whether an amendment requires approval by the regulatory bodies and ensuring that the necessary local approvals have been obtained prior to implementing the changes. 2.3 The PI must ensure that they, and their study staff, comply with the requirements set out in section The PI of a CTIMP, a trial of a non-ce marked device, must ensure that they, and their staff, comply with the requirements set out in section If the PI leaves the employment of the Trust then they should stand down as the PI. Principal Investigators are not allowed to transfer studies that are taking place at the Trust to another site The PI should notify a senior R&D manager and the Sponsor (if not Papworth) that they are leaving their post as soon as is possible so that alternative arrangements can be made The existing Investigator will nominate an alternative who will be approached subject to approval by the Sponsor, a Senior R&D manager and members of the Clinical Directorates that the study concerns. STUDY CLOSE DOWN Principal Investigator Trial Closure & End of Trial Reporting SOP021 Archiving SOP It is the responsibility of the Principal Investigator based at Papworth, or the Trial Manager, to inform the sponsor and R&D Department (if different) of trial closure or suspension at Papworth Hospital Clinical trial documentation can be archived by either the Investigator or the Sponsor as defined in the contract. Page 12 of 14

13 APPENDIX 4: RESPONSIBILITIES OF ALL RESEARCH STAFF Misconduct and Fraud: Good Research Practice SOP052 GCP Training for Research Staff SOP049 Training Records SOP All research staff are responsible for the quality and safety of the research studies that they are involved in and as such should familiarise themselves with the standards expected of them and the procedures for raising concerns The Trust requires that all staff involved in clinical trials (i.e. trials that require MHRA approval) and surgical/interventional trials must undertake GCP training The Trust recommends that all staff undertaking researchrelated activities that lie outside of the normal care pathway receive GCP training prior to their involvement in a research study For clinical trials, the Trust requires staff to have undertaken a nationally recognised course. To this end, courses such as the National Institute for Health Research (NIHR) GCP course, is recommended Each individual member of staff is responsible for the creation and maintenance of their training record and ensuring it is fit for both internal and external audit SOP training will be documented on the SOP Training Record Sheet, which is available on the R&D intranet site. By signing this sheet the employee is confirming that they have read and understood the SOP, and that they agree to undertake the procedure within the scope of their role Members of staff are responsible for submitting copies of their CV and current GCP training certificates to the department administrator for uploading onto the research database: ReDA. Page 13 of 14

14 Further Document Information Approved by: Management/Clinical Directorate Group Approval date: (this version) Ratified by Board of Directors/ Committee of the Board of Directors Date: This document supports: Standards and legislation Research and Development Directorate 13 th June 2013 (Chairman s action) STET N/A Medicines for Human Use (Clinical ) Regulations 2004 and all associated amendments. Research Governance Framework for Health and Social Care (2005) Key related documents: Trust Research Policy Research and Development Standard Operating Procedures entitled: SOP030 Roles and Responsibilities/Delegation Log. Trust Policy DN48 Case Note Retention & Disposal of Patient Records Equality Impact Assessment: Does this document impact on any of the following groups? If YES, state positive or negative, complete Equality Impact Assessment Form available in Disability Equality Scheme document DN192 and attach. Groups: Disability Race Gender Age Sexual orientation Religious & belief Yes/No: NO NO NO NO NO NO NO Positive/ Negative: Review date: April 2016 Other Version Control Version Date Effective Valid To Approved by Date of Approval nd Aug 2013 April 2016 RDD (Chairman s 12 th June 2013 action) Page 14 of 14

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