R&D Administration Manager. Research and Development. Research and Development
|
|
- Frederick Foster
- 7 years ago
- Views:
Transcription
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
R&D Administration Manager. Research and Development. Research and Development
Document Title: Document Number: Patient Recruitment SOP031 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager,
More informationDocument Title: Trust Approval and Research Governance
Document Title: Trust Approval and Research Governance Document Number: SOP034 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D
More informationDocument Title: Project Management of Papworth Sponsored Studies
Document Title: Project Management of Papworth Sponsored Studies Document Number: SOP009 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G
More informationDocument Title: Research Database Application (ReDA)
Document Title: Research Database Application (ReDA) Document Number: SOP035 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D
More informationROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS
ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:
More informationDocument Title: Supply of Clinical Trials Investigational Material: Dispensing, Returns and Accountability
Document Title: Supply of Clinical Trials Investigational Material: Document Number: SOP072 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G
More informationArchiving of Research Documentation
Suspension, Termination & Completion Standard Operating Procedure VERSION / REVISION: 2.0 EFFECTIVE DATE: 28 05 12 REVIEW DATE: 28 05 14 AUTHOR(S): CONTROLLER: APPROVED BY: Clinical Trials Manager; Recruitment
More informationTRIAL MASTER FILE- SPONSORED
gsop-06-04 - Management of TMF for ENHT/ WHHT Sponsored CTIMPs Page 1 of 16 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust TRIAL MASTER
More informationMarie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager
Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name
More informationStandard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL
Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,
More informationStandard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Undertaking Risk Assessment of a Research and Development Project SOP Number: 33 Version Number: 1.0 Supercedes: N/A Effective
More informationgsop-32-02 - Vendor Assessment SOP page 1 of 10
gsop-32-02 - Vendor Assessment SOP page 1 of 10 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust VENDOR ASSESSMENT Research & Development
More informationSummary of the role and operation of NHS Research Management Offices in England
Summary of the role and operation of NHS Research Management Offices in England The purpose of this document is to clearly explain, at the operational level, the activities undertaken by NHS R&D Offices
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol
More informationSTANDARD OPERATING PROCEDURE. Risk Assessment of STH sponsored CTIMPs
Research Department STANDARD OPERATING PROCEDURE of STH sponsored CTIMPs SOP History None SOP Number C118 Created STH Research Department (EW) Reviewed STH Research Department (EW) Superseded Version 1.0,
More informationJoint Research Office
Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Postal Address: UCL, Gower Street London WC1E 6BT Email: hameedah.bogle-dawoud@nhs.net Tel No. 020
More informationStandard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager
Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s Author: Lisa Austin, Research Manager Purpose and Objective: To identify and standardise
More informationThe Study Site Master File and Essential Documents
The Study Site Master File and Essential Documents Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 002 Version number: 1 Effective date: 01 June 2010
More informationWhat is necessary to provide good clinical data for a clinical trial?
What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction
More informationCONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator
Research Department STANDARD OPERATING PROCEDURE STH Investigator Archiving of Essential Documentation Generated During Clinical Research SOP Number A127 Version Number V1.3 Effective Date Author Zoe Whiteley
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders
STANDARD OPERATING PROCEDURE FOR RESEARCH Management of Essential Documents and Trial Folders Author Linda Ward Author s Job Title QA Coordinator Division Department Version number 2 Ref SOP/CLN/001/2
More informationManaging & Validating Research Data
Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical
More informationINTERIM SITE MONITORING PROCEDURE
INTERIM SITE MONITORING PROCEDURE 1. PURPOSE The purpose of this SOP is to describe the interim monitoring procedures conducted at Institution, according to GCP and other applicable local regulations.
More informationSOP Number: SOP-QA-34 Version No: 1. Version Description of Changes Date Effective. Change of number for Q-Pulse (Replaces UoA-NHSG-SOP-051 V1)
Standard Operating Procedure: SOP Number: SOP-QA-34 Version No: 1 Author: Date: 1-9-15 (Carole Edwards, Lead Research Nurse, NHS Grampian) Approved by: Date: 1-9-15 (Professor Julie Brittenden, R&D Director,
More informationRESEARCH GOVERNANCE POLICY
RESEARCH GOVERNANCE POLICY Policy Title Version: Approved by: Date of approval: 29 June 2015 Policy supersedes: Lead Board Director: Policy Lead (and author if different): Name of responsible committee/group:
More informationThis SOP may also be used by staff from other NHS areas, or organisations, with prior agreement.
Standard Operating Procedure: SOP Number: SOP-QA-32 Version No: 1 Author: Date: (Gary Cooper, Named Sponsor Archivist, NHS Grampian and University of Aberdeen) 1-9-15 Approved by: Date: 1-9-15 (Professor
More informationJRO RMG RSS SOP 12. Standard Operating Procedure (SOP) for Study Closedown and Archiving Royal Free site specific SOP
Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Tel No. 0845 1555 000 Web-sites: www.uclh.nhs.uk; www.ucl.ac.uk/jro Postal Address: UCL, Gower Street
More informationRD SOP17 Research data management and security
RD SOP17 Research data management and security Version Number: V2 Name of originator/author: Dr Andy Mee, R&I Manager Name of responsible committee: R&I Committee Name of executive lead: Medical Director
More informationEssential Documentation and the Creation and Maintenance of Trial Master Files
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationIntroduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6
Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication
More informationUNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE
UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL)
More informationRESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS. Research Governance Group
RESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS Reference No: UHB 074 Version No: 5 Previous Trust / LHB Ref No: N/A Documents to read alongside
More informationCONTROLLED DOCUMENT. Uncontrolled Copy. RDS014 Research Related Archiving. University Hospitals Birmingham NHS Foundation Trust
University Hospitals Birmingham NHS Foundation Trust CONTROLLED DOCUMENT RDS014 Research Related Archiving CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 1 Controlled Document
More informationTrust/Host Site Approval. Presented by: Anika Kadchha Research Governance Officer
Trust/Host Site Approval Presented by: Anika Kadchha Research Governance Officer Joint Research & Enterprise Office Training 19 th January Outline What is Research NHS Ethics (if required) Host Site Approval
More informationAn introduction to Research Management and Governance (RM&G) in the NHS
An introduction to Research Management and Governance (RM&G) in the NHS Rachel Davis Assistant RM&G Project Manager Natassia Embury R&D Facilitator 14/04/2014 Delivering clinical research to make patients,
More informationClinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good
More informationEssentials of RESEARCH GOVERNANCE
Promoting Good Practice in Research Essentials of RESEARCH GOVERNANCE Information for Researchers, Students and Support Staff involved in Health & Social Care Research 2005 Reproduced with the permission
More informationTrial Delivery SOP 05 Trial Archiving
Gloucestershire Research and Development Consortium Standard Operating Procedure R&D SOP TD 05Trial Archiving Trial Delivery SOP 05 Trial Archiving IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO
More informationDATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS
Reference Number: UHB 139 Version Number: 2 Date of Next Review: 14 Apr 2018 Previous Trust/LHB Reference Number: N/A DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS Introduction and Aim
More informationCCG: IG06: Records Management Policy and Strategy
Corporate CCG: IG06: Records Management Policy and Strategy Version Number Date Issued Review Date V3 08/01/2016 01/01/2018 Prepared By: Consultation Process: Senior Governance Manager, NECS CCG Head of
More informationRECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING
RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.
More informationNational Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP)
National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) Operating Manual Please check the CRN Website for the latest version. Version: 6.0 Status: Consultation in
More informationEMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
More informationHow To Protect Your Personal Information At A College
Data Protection Policy Policy Details Produced by Assistant Principal Information Systems Date produced Approved by Senior Leadership Team (SLT) Date approved July 2011 Linked Policies and Freedom of Information
More informationINFORMATION GOVERNANCE OPERATING POLICY & FRAMEWORK
INFORMATION GOVERNANCE OPERATING POLICY & FRAMEWORK Log / Control Sheet Responsible Officer: Chief Finance Officer Clinical Lead: Dr J Parker, Caldicott Guardian Author: Associate IG Specialist, Yorkshire
More informationTEMPLATE DATA MANAGEMENT PLAN
TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager
More informationThe EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark Question 1: What laws or regulations apply to an application for conducting a clinical
More informationMANAGEMENT OF POLICIES, PROCEDURES AND OTHER WRITTEN CONTROL DOCUMENTS
MANAGEMENT OF POLICIES, PROCEDURES AND OTHER WRITTEN CONTROL DOCUMENTS Document Reference No: Version No: 6 PtHB / CP 012 Issue Date: April 2015 Review Date: January 2018 Expiry Date: April 2018 Author:
More informationSOP Number: SOP-QA-20 Version No: 1. Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen)
Standard Operating Procedure: SOP Number: SOP-QA-20 Version No: 1 Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen) Approved by: Date: 1-9-15 (Professor Julie Brittenden,
More informationGood Clinical Practice (GCP)
Good Clinical Practice (GCP) Joanne Thompson Clinical Trials Monitor and Trainer, UHL Dec 2011 1 1 What is GCP? An international ethical and scientific quality standard for designing, conducting, recording
More informationPolicy Flowchart. Policy Title: Research Governance, Conduct and Management Policy. Reference and Version No: IG6 Version 5
Policy Title: Research Governance, Conduct and Management Policy Reference and Version No: IG6 Version 5 Author and Job Title: J Greenaway Research and Development Manager Executive Lead Medical Director
More informationDepartment of Health - Research Governance Framework (RGF)
LIVERPOOL JOHN MOORES UNIVERSITY SPONSORSHIP OF RESEARCH PROJECTS UNDER THE RESEARCH GOVERNANCE FRAMEWORK FOR HEALTH AND SOCIAL CARE April 2015 1 Background The Department of Health s Research Governance
More informationINFORMATION GOVERNANCE POLICY
INFORMATION GOVERNANCE POLICY Primary Intranet Location Information Management & Governance Version Number Next Review Year Next Review Month 7.0 2018 January Current Author Phil Cottis Author s Job Title
More informationHuman Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities
This Guidance Document is to ensure that investigators and research personnel recognize their responsibilities associated with the conduct of human subject research by outlining their responsibilities,
More informationInformation Governance Policy
Information Governance Policy Version 1.1 Responsible Person Information Governance Manager Lead Director Head of Corporate Services Consultation Route Information Governance Steering Group Approval Route
More informationResearch Study Close-down and Archiving Procedures
Title: Outcome Statement: Research Study Close-down and Archiving Procedures To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.
More informationINFORMATION GOVERNANCE POLICY
INFORMATION GOVERNANCE POLICY Name of Policy Author: Name of Review/Development Body: Ratification Body: Ruth Drewett Information Governance Steering Group Committee Trust Board : April 2015 Review date:
More informationSite visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066
Site visit inspection report on compliance with HTA minimum standards London School of Hygiene & Tropical Medicine HTA licensing number 12066 Licensed under the Human Tissue Act 2004 for the storage of
More informationResearch & Development Directorate
Research & Development Directorate Type of Document Standard Operating Procedure Name SOP10: Routine Audit Version 3.0 Author Miss Jennifer Boyle (Research Governance Co-ordinator) Version Superseded 2.4
More informationINFORMATION GOVERNANCE POLICY
INFORMATION GOVERNANCE POLICY Version: 3.2 Authorisation Committee: Date of Authorisation: May 2014 Ratification Committee Level 1 documents): Date of Ratification Level 1 documents): Signature of ratifying
More informationRISK MANAGEMENT STRATEGY 2014-17
RISK MANAGEMENT STRATEGY 2014-17 DOCUMENT NO: Lead author/initiator(s): Contact email address: Developed by: Approved by: DN128 Head of Quality Performance Julia.sirett@ccs.nhs.uk Quality Performance Team
More informationDorset Research Consortium. Research Governance: A handbook for Researchers in Dorset
Dorset Research Consortium Research Governance: A handbook for Researchers in Dorset DRC Version 1 dated 25 th July 2012 Research Governance: The Basics... 4 What is Research Governance?... 4 The Research
More informationInformation Governance Policy
Information Governance Policy Version: 4 Bodies consulted: Caldicott Guardian, IM&T Directors Approved by: MT Date Approved: 27/10/2015 Lead Manager: Governance Manager Responsible Director: SIRO Date
More informationInformation Governance Policy
Information Governance Policy Information Governance Policy Issue Date: June 2014 Document Number: POL_1008 Prepared by: Information Governance Senior Manager Insert heading depending on Insert line heading
More informationINFORMATION GOVERNANCE POLICY
INFORMATION GOVERNANCE POLICY Issued by: Senior Information Risk Owner Policy Classification: Policy No: POLIG001 Information Governance Issue No: 1 Date Issued: 18/11/2013 Page No: 1 of 16 Review Date:
More informationINFORMATION GOVERNANCE POLICY
INFORMATION GOVERNANCE POLICY Information Governance Policy_v2.0_060913_LP Page 1 of 14 Information Reader Box Directorate Purpose Document Purpose Document Name Author Corporate Governance Guidance Policy
More informationManaging Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey
Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Aim of the session To explore the risks associated with clinical research and understand how
More informationNHS Commissioning Board: Information governance policy
NHS Commissioning Board: Information governance policy DOCUMENT STATUS: To be approved / Approved DOCUMENT RATIFIED BY: DATE ISSUED: October 2012 DATE TO BE REVIEWED: April 2013 2 AMENDMENT HISTORY: VERSION
More informationPolicy Document Control Page
Policy Document Control Page Title Title: Information Governance Policy Version: 5 Reference Number: CO44 Keywords: Information Governance Supersedes Supersedes: Version 4 Description of Amendment(s):
More informationPolicy: D9 Data Quality Policy
Policy: D9 Data Quality Policy Version: D9/02 Ratified by: Trust Management Team Date ratified: 16 th October 2013 Title of Author: Head of Knowledge Management Title of responsible Director Director of
More informationA Guide to Pharmacy Documentation For Clinical Trials
A Guide to Pharmacy Documentation For Clinical Trials Roy Sinclair Clinical Trials Pharmacist St. George s Hospital (to Sep 2007) Lecturer Kingston University January 2008 A Guide to Pharmacy Documentation
More informationArchiving of Clinical Trial Data and Essential Documentation JCTO/CT/SOP 4.0. Joint Clinical Trials Office. Stuart Hatcher, JCTO Archivist
Archiving of Clinical Trial Data and Essential Documentation Policy Details Document Type Standard Operating Procedure Document name Change History Date Version Number JCTO/CT/SOP 4.0 Version Final v 2.0-09/11/2010
More informationAll CCG staff. This policy is due for review on the latest date shown above. After this date, policy and process documents may become invalid.
Policy Type Information Governance Corporate Standing Operating Procedure Human Resources X Policy Name CCG IG03 Information Governance & Information Risk Policy Status Committee approved by Final Governance,
More informationDocument Number: SOP/RAD/SEHSCT/007 Page 1 of 17 Version 2.0
Standard Operating Procedures (SOPs) Research and Development Office Title of SOP: Computerised Systems for Clinical Trials SOP Number: 7 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013
More information12.0 Investigator Responsibilities
v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,
More informationCentral Alert System (CAS) Policy and Procedure
Central Alert System (CAS) Policy and Procedure POLICY NUMBER Risk, Health & Safety.068 POLICY VERSION RATIFYING COMMITTEE Professional Practice Forum Most Recent DATE RATIFIED 26 April 2015 DATE OF EQUALITY
More informationClinical Research Nurse (CRN)
1 JOB IDENTIFICATION Job title: Responsible to: Department: Division/directorate: Job reference no.: No. of CRNs: Last update: (CRN) Senior Research Nurse Consultant/ Unit Manager /PI Add local specifications
More informationNursing Agencies. Minimum Standards
Nursing Agencies Minimum Standards 1 Contents Page Introduction 3 Values underpinning the standards 6 SECTION 1 - MINIMUM STANDARDS Management of the nursing agency 1. Management and control of operations
More informationType of change. V02 Review Feb 13. V02.1 Update Jun 14 Section 6 NPSAS Alerts
Document Title Reference Number Lead Officer Author(s) (name and designation) Ratified By Central Alerting System (CAS) Policy NTW(O)17 Medical Director Tony Gray Head of Safety and Patient Experience
More informationMANAGEMENT OF PERSONAL FILES POLICY
MANAGEMENT OF PERSONAL FILES POLICY Executive Director lead Author/ lead Feedback on implementation to Andrew Avery (Interim Director of HR) Liz Thompson (HR Manager) Liz Thompson (HR Manager) Date of
More informationStudy-wide considerations: identifies the areas of the criterion the lead reviewer should consider when conducting the review
UK STUDY-WIDE GOVERNANCE CRITERIA FOR R&D REVIEW INTRODUCTION The following document is intended to provide operational guidance to the person taking the UK lead in conducting the R&D Study-Wide review
More informationProcedure for Non-Medical Staff who wish to Request MRI, Ultrasound and Imaging Examinations under IR(ME)R
Procedure for Non-Medical Staff who wish to Request MRI, Ultrasound and Imaging V3.0 December 2013 Page 1 of 11 Table of Contents 1. Introduction... 3 2. Purpose of this Policy/Procedure... 3 3. Scope...
More informationNORWICH CLINICAL TRIALS UNIT OVERVIEW
NORWICH CLINICAL TRIALS UNIT OVERVIEW This document provides an overview of the Norwich Clinical Trials Unit. Sections 1 to 3 describe the Norwich Clinical Trials Unit remit and structure. Section 4 gives
More informationDESCRIPTION OF THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004
DESCRIPTION OF THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 Page 1 of 17 TABLE OF CONTENTS INTRODUCTION 4 EXECUTIVE SUMMARY 4 PUBLIC HEALTH BENEFITS 5 Good clinical practice 5 Good manufacturing
More informationSection 5 onwards provides information aimed at researchers who are interested in working with us.
NORWICH CLINICAL TRIALS UNIT This document provides an overview of the Norwich Clinical Trials Unit: Sections 1 to 3 describe the Norwich Clinical Trials Unit remit and structure for our stakeholders and
More informationEU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE
EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare
More informationInformation Governance Strategy. Version No 2.1
Livewell Southwest Information Governance Strategy Version No 2.1 Notice to staff using a paper copy of this guidance. The policies and procedures page of LSW Intranet holds the most recent version of
More informationStandard Operating Procedures
Standard Operating Procedures 5.5.1 Electronic Data Handling History Version Date Author Reason 1.1 18 th July 2007 B Fazekas New procedure 1.2 18 th August B Fazekas Changes ratified by MAB 2007 1.3 16
More informationHow To Inspect A Blood Bank
Site visit inspection report on compliance with HTA minimum standards Belfast Cord Blood Bank HTA licensing number 11077 Licensed for the procurement, processing, testing, storage, distribution and import/export
More informationGrievance and Disputes Policy and Procedure. Document Title. Date Issued/Approved: 10 August 2010. Date Valid From: 21 December 2015
POLICY UNDER REVIEW Please note that this policy is under review. It does, however, remain current Trust policy subject to any recent legislative changes, national policy instruction (NHS or Department
More informationGuidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research
Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research 1. Objective: The objective of this SOP is to contribute to the effective functioning
More informationStandard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Medicinal Products (CTIMPs)
archiving\spon_s21_sop_for_archiving V02.doc Page 1 of 13 Standard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Medicinal Products (CTIMPs) SOP
More informationThe EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Norway
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Norway Question 1: What laws or regulations apply to an application for conducting a clinical
More informationQ1. Why have you revised the guidance on attributing Research Costs, Support Costs and Treatments Cost in the NHS?
Annex B Frequently Asked Questions Updated May 2015 Q1. Why have you revised the guidance on attributing Research Costs, Support Costs and Treatments Cost in the NHS? A. The definitions of Research Costs,
More informationRisk Management Policy and Process Guide
Risk Management Policy and Process Guide Status: pending Next review date: December 2015 Page 1 Information Reader Box Directorate Medical Nursing Patients & Information Commissioning Operations (including
More informationMOORLAND SURGICAL SUPPLIES LTD INFORMATION GOVERNANCE POLICY
MOORLAND SURGICAL SUPPLIES LTD INFORMATION GOVERNANCE POLICY Moorland is committed to ensuring that, as far as it is reasonably practicable, the way we provide services to the public and the way we treat
More informationPROTOCOL FOR DUAL DIAGNOSIS WORKING
PROTOCOL FOR DUAL DIAGNOSIS WORKING Protocol Details NHFT document reference CLPr021 Version Version 2 March 2015 Date Ratified 19.03.15 Ratified by Trust Protocol Board Implementation Date 20.03.15 Responsible
More informationSafety Alerts Management Policy
Safety Alerts Management Policy Version Number 1.1 Version Date February 2014 Policy Owner Author First approval or date last reviewed Staff/Groups Consulted Director of Nursing and Clinical Governance
More informationInformation Integrity & Data Management
Group Standard Information Integrity & Data Management Serco recognises its responsibility to ensure that any information and data produced meets customer, legislative and regulatory requirements and is
More informationAudit and Performance Committee Report
Audit and Performance Committee Report Date: 3 February 2016 Classification: Title: Wards Affected: Financial Summary: Report of: Author: General Release Maintaining High Ethical Standards at the City
More information