SOP14a: Standard Operating Procedure Applying for Ethical Approval
|
|
- Flora Jordan
- 5 years ago
- Views:
Transcription
1 SOP14a: Standard Operating Procedure Applying for Ethical Approval Authorship Team: Jemma Hughes for Joint SOP Group on Trial Processes (viz Leanne Quinn, Ian Russell, Anne Seagrove, John Williams, Bridget Wells) Authorised for implementation by: the Director of WWORTH Signature Date 0 Version Record Version Number Effective Date Reason for Change 0 01 Dec 2008 Derived from SOP approved by NWORTH Mar 2009 Reviewed by JSOPG on 27 th March Apr 2009 Further edits based on discussions at JSOPG on 27 Mar May 2009 Further edits based on discussions at JSOPG on 27 Mar May 2009 Further edits based on discussions at JSOPG on 22 May Sept 2009 Further edits based on final review at 10 Jul 09. Approved in principle by JSOPG May 2010 Minor formatting amendments Apr 2012 Minor edits: inserted Section 7 Training May 2012 Edits following JSOPG in preparation for JEG sign off Sept 2012 Minor amendments after JEG approval Jan 2014 Updated header, formatting amendments, introduction updated, references renumbered Mar 2014 Updates required based on discussions at JSOPG 17 Jan Mar 2014 Referencing corrected MS/ACS May 2014 Remove training log post JSOPG discussion - MS & CS WWORTH-SOP14aEthicsRGApprovalV Page 1 of 21 Not guaranteed if printed
2 1 Table of Contents 0 Version Record Table of Contents Glossary Introduction Purpose Roles & Responsibilities Procedure Making an Initial Application on IRAS Flow Diagram for Application to NHS Ethics Committee Submission of amendments for review Ethical & Governance Review of Non-Patient and/or Non NHS Trials Training Plan References Related SOPs Appendices...16 Appendix 1: Notification of substantial amendments to CTIMPS...17 Appendix 2: Algorithm Defining Research...21 WWORTH-SOP14aEthicsRGApprovalV Page 2 of 21 Not guaranteed if printed
3 2 Glossary The full Glossary is in Swansea University H drive/documents/526- WWORTH/Development Group/Glossary. The terms of particular relevance to this SOP are: 3 Introduction Standard Operating Procedures (SOPs) are succinct formal documents designed to achieve consistency in specified trial functions by specifying standard practice in performing those functions (GCP 1.55 & EMeA, 2002). While SOPs should cite relevant legislation & regulations, and key references & evidence, they need not expound theory. WWORTH SOPs should accord with all relevant regulations, including the European Union Clinical Trial Directive 1, ICH Good Clinical Practice (GCP) 2 and the current NHS Research Governance Framework. 3 They will seek to distinguish between regulations for Clinical Trials of a Medicinal Products (CTIMPs) and for other research. This document forms part of the set of standard operating procedures of the West Wales Organisation for Rigorous Trials in Health (WWORTH). WWORTH SOPs are written in compliance with regulatory requirements, EU clinical trial directive, ICH Good Clinical Practice and Internal Guidelines-the Research Governance Framework. All SOPs will distinguish regulatory requirements between Clinical Trials of an Investigational Medicinal Products (CTIMPs) and other research (non drug trials). The World Medical Association in its Declaration of Helsinki states in Sections The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. WWORTH-SOP14aEthicsRGApprovalV Page 3 of 21 Not guaranteed if printed
4 In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions. 23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study s findings and conclusions. 4 In the UK, ethical review is one of a series of safeguards intended to protect individuals as described in the Research Governance Framework for Health and Social Care on the Department of Health's website. 3 The primary function of a Research Ethics Committee (REC) when considering a proposed study is to protect the rights, safety, dignity and well-being of all actual or potential participants as well as the researchers themselves. The remit of RECs is described in the Department of Health's guidance, Governance Arrangements for Research Ethics Committees (GAfREC) which is located on their website. 5 In addition to ethical review, the scientific value and governance arrangements of all proposed research must be considered by National Health Service Research & Development (NHS R&D) Departments at all relevant research sites. NHS R&D departments have the responsibility for assessing the governance, safety, suitability and capacity for conducting the research. For Studies with a request for Sponsorship by ABMU Health Board or Swansea University, a scientific review may be necessary via the Joint Scientific Review Committee. Please contact the ABMU R&D Department to discuss scientific review prior to submitting to Ethics. For full details on the Sponsorship and Adoption process and NHS R&D Submission, please refer to WWORTH SOP31 Sponsorship and Adoption and WWORTH SOP14b NHS R&D Permission respectively.). Ethical approval and approval from relevant NHS R&D departments must be obtained before any study can start at any site. WWORTH-SOP14aEthicsRGApprovalV Page 4 of 21 Not guaranteed if printed
5 4 Purpose The purpose of this SOP is to offer guidance to researchers on the principles and processes pertaining to seeking Research Ethics Approval. 5 Roles & Responsibilities It is the responsibility of the Sponsor to ensure all regulatory approvals are in place before a study begins at any site. This may be delegated to the CI or Director of WWORTH. The Director in turn may delegate to a suitably qualified person such as the Trial Manager (TM), Principal Investigator (PI) or a member of the WWORTH team depending on the nature of the study. The CI has overall responsibility for the research. In a multi-site study, the CI has co-ordinating responsibility for research at all sites. All applications for ethical review should be submitted by the CI. It is the responsibility of the TM to support the CI and Trial Management Group (TMG) in the application. If a TM is not in post, this may be delegated to the WWORTH Unit Manager. The CI is required to sign the final application. The PI has the responsibility of ensuring NHS R&D approval is obtained prior to starting the research at their site; this will include the submission of the Site Specific information form (SSIF) for that site alongside the generic IRAS R&D form for NHS R&D Management review. In the case of a single-site study, the CI and PI will usually be the same person and will be required to submit to LREC for ethical review and NHS R&D for management review. Please refer to WWORTH SOP14b NHS R&D Permission for full details on the NHS R&D Submission process. It is the responsibility of the CI, PI, TM or delegated individual to ensure that sites taking part in the research complete the SSIF and obtain NHS R&D approval before site initiation and set up takes place in accordance with WWORTH SOP16 Site Setup. The CI, PI, TM or delegated individual also has responsibility for ensuring copies of all ethical and R&D approvals are stored within the Trial Master File (TMF) and relevant Trial Site File (TSF) in accordance with WWORTH SOP03 Master Site File. 6 Procedure 6.1 Making an Initial Application on IRAS Ethical approval from the appropriate NHS REC (i.e. LREC) & NHS R&D Departments is required for any research involving staff, patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user's past or present treatment by, or WWORTH-SOP14aEthicsRGApprovalV Page 5 of 21 Not guaranteed if printed
6 use of the NHS. It includes NHS patients treated under contracts with private sector institutions; individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above; access to data, organs or other bodily material of past and present NHS patients; foetal material and In Vitro Fertilisation involving NHS patients; the recently dead in NHS premises; the use of or potential access to NHS premises or facilities. Selection of participants by virtue of the fact that they are employed by or work within an NHS Organisation also requires ethical approval. For research involving two or more centres, approval must be sought from a multi domain NHS Research Ethics Committee (NHS REC). NHS REC approval issued by a multi domain Committee applies to all NHS organisations involved in the research. Thus individual local NHS RECs are not required to consider the proposal. To include additional sites at a later date, an amendment application should be notified to the original reviewing REC and NHS R&D Permission obtained from the new NHS site (please refer to WWORTH SOP14b NHS R&D Permission). All applications for ethical approval and NHS R&D approval must be made using an electronic on-line system known as the Integrated Research Application System (IRAS). There are detailed help guides available on IRAS to guide applicants through the submission process, however NRES continues to operate as the overarching body responsible for all RECs in the UK and the HRA website offers applicants with detailed guidance on all aspects of the ethics submission process ( To make an application for ethical and/or NHS R&D review, go to the IRAS website. 6 If you are a first time user, you will need to register for an account online, which is activated immediately. It is important to follow the question-specific guidance, also available from. 6 Once logged in, you will be directed to a project filter page which enables you to specify which approval bodies you need approval from and will ensure the correct application forms are generated for you. All forms are then completed online and can be downloaded into PDF or XML format in preparation for submission to the relevant bodies. For multicentre studies in England, the NHS R&D form is submitted via a Coordinated System for gaining NHS Permission (CSP). Within Wales, all applications should be sent to the NISCHR Permissions Unit. Please refer to WWORTH SOP14b NHS R&D Permission for full guidance on NHS R&D submission process. WWORTH-SOP14aEthicsRGApprovalV Page 6 of 21 Not guaranteed if printed
7 Note that the Ethical approval process has a timeline after you have phoned the Central Allocation System or your Local Allocation System to book in your application; therefore it is important to start preparing your submission as soon as funding is approved. WWORTH-SOP14aEthicsRGApprovalV Page 7 of 21 Not guaranteed if printed
8 6.2 Flow Diagram for Application to NHS Ethics Committee Once you have completed the IRAS REC application and have supporting documents, phone the Central Allocation System or Local Allocation System to book in the application. Submit Parts A&B of the application form and supporting documents direct to the REC within 4 working days of the booking REC Coordinator validates application (5 working days) Valid Application CI invited to REC meeting, or to be available by phone. Invalid application returned, booking process starts again. Application reviewed by the main REC Favourable Opinion (within 60 days) Provisional opinion (60 days clock stops) Modify application (60 day clock restarts) Modifications reviewed by Chair or Sub-committee Favourable or Unfavourable Opinion (within 60 days) If the study involves an Investigational Medicinal Product (IMP) or medical device, you must apply for authorisation from the MHRA either at the same time as you make your REC application or in sequence. This application can now also be made via the IRAS form, with guidance available from the website. Please refer to WWORTH SOP15 MHRA Approval and the MHRA website for guidance. 7 caltrials/index.htm WWORTH-SOP14aEthicsRGApprovalV Page 8 of 21 Not guaranteed if printed
9 The REC application form for CTIMP has a space to enter the EudraCT number, which allows the REC to link your application for ethics approval to your application to the MHRA for a CTA. The EudraCT number is the mandatory reference number allocated by the European Medicines Agency (EMeA) for CTIMPS authorised on or after 1 May 2004 and can be sought via IRAS. Further details can be found from reference 7 Clinicaltrials/index.htm Please also refer to WWORTH- SOP15MHRAapproval. If the research involves the use of patient identifiable information without consent, you will need to apply to the NIGB after you have received a favourable REC opinion. Again, application for NIGB approval is applied for via IRAS. It is strongly recommended that funding is secured and NHS R&D support in principle is obtained before making REC applications. There are different types of NHS REC across the UK that review different kinds of studies. There is detailed guidance on the HRA Research Community web page 8 to determine the appropriate REC for your study. There is no application fee for ethical review by an NHS REC. Applicants should submit the application before the deadline given by the REC for applications to be reviewed at the target meeting. Failure to do so will delay consideration of the application until a subsequent meeting. Applicants should provide all requested information, especially full responses to reviewers comments. A standard letter confirming validation or not will be sent within 5 days. For multicentre studies, once the CI receives the validation letter, the Sponsor or CI can instruct the Trial Manager or individual PIs to apply for NHS R&D permission at each site. To allow this the CI or delegated person completing the application sends the SSIF to each PI for completion and submission. This is done by the transferring the SSIF electronically to the PI, via IRAS, who then completes and signs it before sending it for NHS R&D review assessment, following the submission guidance in WWORTH SOP14b NHS R&D Permission. The application for NHS R&D permission consists of the SSIF, IRAS R&D form, Research protocol, sample participant information sheets (PIS), informed consent forms (ICF) (see WWORTH SOP05 Participant Info Consent), copy of MHRA authorisation (if applicable), REC approval letter, the PIs CV and draft clinical trial agreement for review. Following a satisfactory review by each NHS R&D department, an approval letter for that NHS Permission will be issued to the PI and a clinical trial agreement will be signed (if applicable). WWORTH-SOP14aEthicsRGApprovalV Page 9 of 21 Not guaranteed if printed
10 6.3 Submission of amendments for review Once a study has been issued with all its necessary approvals and becomes active, it may become necessary to amend the study thereby altering the information originally submitted and approved. It is advised that all amendments are submitted individually and are self-contained to ensure it is clear which amendments have been given approval. Some amendments will be classified as substantial whilst others will be classified as non-substantial. Only substantial amendments will require full review by the REC and NHS R&D departments. Non-substantial may be notified to the REC and R&D Department, via letter, for information only. It should be documented, by use of a file note, how the decision was made. NRES defines Substantial amendment as an amendment to the terms of the REC application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree: 1. the safety or physical or mental integrity of the subjects of the trial; 2. the scientific value of the trial; 3. the conduct or management of the trial; or 4. the quality or safety of any investigational medicinal product used in the trial. All substantial amendments should be notified to the REC that gave a favourable opinion (the main REC ) using a notice of substantial amendment form 9 A copy of the notification should also be sent to NHS R&D Offices for review. For CTIMPS the EU Notification of Substantial Amendment form should be used. In accordance with the European Commission guidance the form should be submitted to either the main REC or to the MHRA or both as appropriate. This can be created in IRAS by using the Create Notice of Substantial Amendment button on the Amendment tab associated with the REC form. For all other research, the Notice of Substantial Amendment form should be used and is available on IRAS. NRES specifies that within a CTIMP the legal and Primary responsibility for WWORTH-SOP14aEthicsRGApprovalV Page 10 of 21 Not guaranteed if printed
11 determining whether or not an amendment is substantial lies with the sponsor. This may be delegated to the CI or WWORTH. For non-ctimps the main REC has the discretion to decide whether or not a proposed amendment is substantial and requires ethical review. Chief investigators and sponsors should seek advice from the main REC if in doubt. The following amendments should normally be regarded as substantial: changes to the design or methodology of the study, or to background information affecting its scientific value; changes to the procedures undertaken by participants; any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study; changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets for relatives or carers; a change of sponsor(s) or sponsor s legal representative; appointment of a new chief investigator or key collaborator; a change to the insurance or indemnity arrangements for the study; inclusion of a new research site (not listed in the original application) in a study requiring site-specific assessment (SSA); appointment of a new principal investigator at a research site; a significant change to the definition of a research site requiring SSA; a change to the SSA-exempt status of a study; a change to the definition of the end of the study; any other significant change to the protocol or the terms of the REC application. WWORTH-SOP14aEthicsRGApprovalV Page 11 of 21 Not guaranteed if printed
12 Examples of non-substantial amendments might be as follows: correction of typographical errors in the protocol or other study documentation; other minor clarifications of the protocol; updates of the Investigator's Brochure (unless there is a change to the risk/benefit assessment for the trial); changes to the chief investigator s research team (other than appointment of key collaborators); changes to the research team at particular trial sites (other than appointment of a new principal investigator); changes in funding arrangements; changes in the documentation used by the research team for recording study data; changes in the logistical arrangements for storing or transporting samples; inclusion of new sites in SSA-exempt studies; extension of the study beyond the period specified in the application form. NRES also notes that Changes to contact details for the sponsor (or the sponsor s representative), chief investigator or other project staff are minor amendments but should be notified to the main REC for information. Changes to contact details for principal investigators should be notified both to the main REC and the relevant local REC. Notification should also be made to NHS R&D. There are two exceptions to the general rule that substantial amendments must be given a favourable ethical opinion before they can be implemented. These are: where urgent safety measures need to be taken you must notify the main REC and the MHRA (for CTIMPs) immediately and in any event within three days, in the form of a substantial amendment, that such measures have been taken and the reasons why. 10 WWORTH-SOP14aEthicsRGApprovalV Page 12 of 21 Not guaranteed if printed
13 Please also refer to WWORTH SOPs 19a Pharmacovigilance and 19b Urgent Safety Measures for more detail. in the case of some substantial amendments to CTIMPS which require authorisation by the competent authority (MHRA) but may be submitted to the main REC for information only. Please refer to Appendix 2 for full details of notifying substantial amendments for CTIMPS. For more guidance on the submission of amendments for review, please visit the NRES web pages Ethical & Governance Review of Non-Patient and/or Non NHS Trials As a general rule, research studies that do not involve the NHS do not require REC or NHS R&D Review. However, research studies which do not involve patients but involve the NHS e.g. via the involvement of NHS staff or another NHS resource would still require review by NHS R&D departments and potentially also ethical review, depending on the nature of the research. Some studies may not require ethical review but would still require NHS R&D permission, for example retrospective use of clinical anonymised data. It is important to note that studies classified as Audit or Service Evaluation do not require REC or R&D approval but their classification as such must be agreed with the relevant NHS R&D Department. Please refer to Appendix 3 for the algorithm on Defining Research. The process for the review of non-nhs research studies is not formalised by Regulations, it is therefore usually a matter for the internal review processes of the study Sponsor, for example University Schools often have an in-house Ethical Review Panel to scrutinise student research. The SSIF requests that investigators specify whether the research site is NHS or Non-NHS. Non NHS in this regard usually refers to a private company or corporation (for example, a pharmaceutical or biotechnology company or a Site Management Organisation), a private hospital or a private clinical practice. In such cases, the SSIF must be completed and submitted for relevant ethical approval by the REC, whereas for NHS sites, the SSI is submitted as part of the Trust R&D Management review. For further guidance on the completion of the SSIF for non-nhs sites, please contact your local NHS R&D Office or REC. WWORTH-SOP14aEthicsRGApprovalV Page 13 of 21 Not guaranteed if printed
14 7 Training Plan All WWORTH staff involved with trials must undertake the appropriate generic and trial-specific training to ensure that they meet with the specific employers mandatory training requirements and the specific requirements of the trial. For example, for SU staff, all new employees must attend induction, fire and safety training (as well as role-specific training courses, e.g. laboratory safety). For new staff, additional training requirements should be identified alongside the specific role requirements and the WWORTH Unit Manager should make provision for the new staff member to attend the necessary courses as soon after appointment as is practicably possible. It is the responsibility of the WWORTH Unit Manager (alongside the CI or TM) to identify all the SOPs that are relevant to a specific trial and in which the new member of staff should be trained. The WWORTH UM or the SOP author will provide group training for trial staff and/or one-to-one training, as required for new staff in relation to the specific SOPs identified. Training records should be filed both by the main employer and the staff member, in accordance with the specific employer requirements. Trial specific training should be filed in TMF or TSF as appropriate and every individual involved in a trial should have an individual training record (see WWORTH SOP02 Training). Where the tasks specified in the individual SOPs are delegated to WWORTH staff, CIs/PIs or TMs, these delegated staff must ensure that they have attended a training course on GCP and keep up-to-date through attending refresher courses. It is the responsibility of the CI/PI to ensure that all staff allocated duties on the study delegation log template of responsibilities are suitably trained in the activities linked to those duties (see WWORTH SOP16 Site Setup, Appendix 9 and Appendix 10). Each trial should maintain a central training log and ensure that WWORTH has access to that log, not least to integrate the logs of staff who work on more than one trial. Similarly trials should ensure that each site maintains a local training log, not least to integrate the logs of staff who work for more than one sponsor. All WWORTH staff involved with trials must ensure that they are familiar with this SOP. Depending on the requirements of the sponsor, some of the tasks specified in this SOP may be carried out by WWORTH, CIs / PIs or TMs depending on the trial design. Where the tasks specified in this SOP are delegated to WWORTH staff, CIs/ PIs or TMs, they must ensure that they have attended a training course on GCP and keep up-to-date by attending refresher courses. The SOP author will WWORTH-SOP14aEthicsRGApprovalV Page 14 of 21 Not guaranteed if printed
15 provide one-to-one and group training in relation to this SOP as required (see WWORTH SOP02 Training) If a Sponsor that is independent from the University appoints a monitor or monitoring committee, then the Sponsor will be responsible for ensuring adequate training and qualifications are in place. 8 References 1. Directive 2001/20/EC Of The European Parliament And Of The Council Of 4 April Official Journal of the European Communities The European Agency for the Evaluation of Medicinal Products (EMEA). ICH Topic E 6 (R1) Guideline for Good Clinical Practice deline/2009/09/wc pdf 4. Department of Health. Research Governance Framework for Health and Social Care (2nd Edition) s/clinicaltrials/index.htm Related SOPs WWORTH SOP01 SOP on SOPs WWORTH SOP01b Document Control WWORTH-SOP14aEthicsRGApprovalV Page 15 of 21 Not guaranteed if printed
16 WWORTH SOP02 Training WWORTH SOP03 Master and Site File WWORTH SOP05 Participant Info Consent WWORTH SOP14b NHS R&D Permission WWORTH SOP15 MHRA Approval WWORTH SOP16 Site Setup WWORTH SOP19a Pharmacovigilance WWORTH SOP19b Urgent Safety Measures WWORTH SOP31 Sponsorship and Adoption WWORTH SOP32 Detecting and Managing Misconduct, Serious Breaches and Deviations from GCP/Protocol 10 Appendices Appendix 1 - Notification of substantial amendments to CTIMPs Appendix 2 - Algorithm WWORTH-SOP14aEthicsRGApprovalV Page 16 of 21 Not guaranteed if printed
17 Appendix 1: Notification of substantial amendments to CTIMPS ANNEX C: Notification of substantial amendments to CTIMPs The sponsor of a clinical trial of an investigational medicinal product (CTIMP) is required to notify substantial amendments to the MHRA and/or the main REC. The sponsor must indicate on the European Commission notice of amendment form whether the request is for: Authorisation by the competent authority, or Favourable opinion from the ethics committee, or Both authorisation and a favourable ethical opinion. Where a substantial amendment is for review of one body only, there is no requirement to notify the other body for information. It is the responsibility of the sponsor to decide whether an amendment meets the criteria for a substantial amendment, and if so whether it requires authorisation and/or an ethical opinion. However, sponsors may wish to take account of the following general guidance, which has been agreed between NRES and the MHRA. Amendments normally requiring authorisation only New toxicological or pharmacological data or new interpretation of toxicological or pharmacological data of relevance for the investigator. Changes to the reference safety information for the annual safety report. Changes to the Investigational Medicinal Product Dossier (further guidance is in Chapter 8 of the CHMP Guideline on the requirements for chemical and pharmaceutical quality documentation concerning IMPs in clinical trials. Reduction in the sponsor s planned level of monitoring for the trial. Amendments normally requiring a favourable ethical opinion only Significant 1 changes to participant information sheets, consent forms, letters to GPs or other clinicians, letters to relatives/carers, etc (whether generic to the whole study or specific to a particular trial site). Significant changes to recruitment and consent procedures, including the inclusion of adults lacking capacity in the trial. WWORTH-SOP14aEthicsRGApprovalV Page 17 of 21 Not guaranteed if printed
18 Significant increase to the radiation exposures to subjects from the protocol. Change of insurance or indemnity arrangements for the trial. Change to the payments, benefits or incentives to be received by participants or researchers in connection with taking part in the study, or any other change giving rise to a possible conflict of interest on the part of any investigator/collaborator Change of the Chief Investigator. Change of Principal Investigator at a trial site. Addition of new trial sites not listed with the original request for authorisation and REC application. Change to the definition of a trial site. Any other significant change to the conduct or management of the trial at particular trial sites. Early closure or withdrawal of a site. Any other significant change to the terms of the original REC application. Amendments normally requiring both authorisation and a favourable ethical opinion Change of the main objective of the trial. Change of primary or secondary endpoints likely to have a significant impact on the safety or scientific value of the trial. Use of a new measurement for the primary endpoint. New toxicological or pharmacological data or new interpretation of toxicological or pharmacological data which is likely to impact on the risk/benefit assessment. Addition of a trial arm or placebo group. Significant change of inclusion or exclusion criteria (e.g. age range) likely to have a significant impact on the safety or scientific value of the trial. Change of a diagnostic or medical monitoring procedure likely to have a significant impact on the safety or scientific value of the trial. WWORTH-SOP14aEthicsRGApprovalV Page 18 of 21 Not guaranteed if printed
19 Withdrawal of an independent data monitoring committee. Change of IMPs. Change of dosing of IMPs. Change of mode of administration of IMPs. Any other change of study design likely to have a significant impact on primary or major secondary statistical analysis or on the risk/benefit assessment. Change of the sponsor or sponsor s legal representative. Temporary halt of the trial or temporary halt at a trial site, and re-start of the trial following a temporary halt. Change of the definition of the end of the trial. Amendments not normally requiring notification as substantial amendments Changes to the identification of the trial (e.g. change of title) 2 Increase in duration of the trial, provided that the exposure to treatment is not extended, the definition of the end of trial is unchanged and there is no change to monitoring arrangements. Changes to the numbers of participants planned in the UK as a whole or at individual trial sites, provided that there is no change to the total number of participants in the trial or the increase/decrease is insignificant in relation to the overall sample size. Change in the documentation used by the research team to record study data (e.g. case report form or data collection form). Additional safety monitoring which is not part of an urgent safety measure but is taken on a precautionary basis. Changes to the research team other than to Chief or Principal Investigators. Changes to contact details 3 Changes to the internal organisation of the sponsor or persons to whom tasks have been delegated. Changes to the logistical arrangements for transporting or storing samples. WWORTH-SOP14aEthicsRGApprovalV Page 19 of 21 Not guaranteed if printed
20 Changes to technical equipment. Inclusion or withdrawal of another Member State or third country. Non-significant clarifications of the protocol. Non-significant clarifications or updates of participant information documentation. Corrections of typographical errors. The issue of an updated Investigator s Brochure or Summary of Medicinal Product Characteristics for the IMP is not itself regarded as a substantial amendment unless it includes changes that would meet the criteria for a substantial amendment. There is no requirement to provide the MHRA or main REC with updated versions of the Investigator s Brochure or SMPC routinely or to seek authorisation or an ethical opinion. 1 Significant, i.e. likely to affect to a significant degree the safety or physical or mental integrity of trial subjects or the scientific value of the trial, or otherwise significant. 2 Sponsors are requested to notify the REC of this change for information only. 3 Sponsors are requested to notify the REC of changes to the contact details of the sponsor, sponsor s main contact point, sponsor s legal representative (if applicable) or Chief Investigator, for information only.. WWORTH-SOP14aEthicsRGApprovalV Page 20 of 21 Not guaranteed if printed
21 Appendix 2: Algorithm Defining Research Research Service Evaluation Clinical Audit Surveillance Usual Practice (in public health) The attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them. Designed and conducted solely to define or judge current care. Designed and conducted to produce information to inform delivery of best care. Designed to manage outbreak & help the public by identifying & understanding Designed to investigate outbreak or incident to help in disease control and Quantitative research designed to test a hypothesis. Qualitative research identifies/explores themes following established methodology. Addresses clearly defined questions, aims and objectives. Quantitative research may involve evaluating or comparing interventions, particularly new ones. Qualitative research usually involves studying how interventions and relationships are experienced. Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care. Quantitative research study design may involve allocating patients to intervention groups. Qualitative research uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications. Designed to answer: What standard does this service achieve? Measures current service without reference to a standard. Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference. Usually involves analysis of existing data but may include administration of interview or questionnaire. No allocation to intervention: the health professional and patient have chosen intervention before service evaluation. Designed to answer: Does this service reach a Predetermined standard? Measures against a standard. Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference. Usually involves analysis of existing data but may include administration of simple interview or questionnaire. No allocation to intervention: the health professional and patient have chosen intervention before audit. risks associated. Designed to answer: What is the cause of this outbreak? Systematic, statistical methods to allow timely public health action. May involve collecting personal data and samples with the intent to manage the incident. May involve analysis of existing data or administration of interview or questionnaire to those exposed. Does not involve an intervention. prevention. Designed to answer: What is the cause of this outbreak? and treat. Systematic, statistical methods may be used. Any choice of treatment is based on clinical best evidence or professional consensus. May involve administration of interview or questionnaire to those exposed. May involve allocation to control group to assess risk and identify source of incident but treatment unaffected. May involve randomisation. No randomisation. No randomisation. No randomisation. May involve randomisation but not for treatment. Normally requires REC review. Refer to for more information. Does not require REC review. Does not require REC review. Does not require REC review. Does not require REC review. WWORTH-SOP14aEthicsRGapprovalV Page 21 of 21 Not guaranteed if printed
Research & Development. J Illingworth and S Moffat. Research, pharmacy and R&D staff
Department Title of SOP Research & Development SOP reference no: R&D GCP SOP 08 Authors: Reviewed by Current version number and date: J H Pacynko J Illingworth and S Moffat Version 4, 04.02.19 Next review
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 14. Amendments to Research Studies
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 14. Amendments to Research Studies Amendments are changes made
More informationSOP24: Standard Operating Procedure for Randomisation
SOP24: Standard Operating Procedure for Randomisation Authorship Team: Alan Watkins for Joint SOP Group on Trial Techniques (viz Bridget Wells, Kerina Jones, Moira Morgan, Sian Davies, Sinead Brophy, Steve
More informationSOP01a: Standard Operating Procedure for Developing, Reviewing and Approving Standard Operating Procedures
SOP01a: Standard Operating Procedure for Developing, Reviewing and Approving Standard Operating Procedures Authorship team: Ian Russell for Joint SOP Group on Trial Administration (viz Angela Evans, Sarah
More informationRESEARCH AUDIT Standard Operating Procedure
Reference Number: UHB 236 Version Number: 2 Date of Next Review: 17 th Oct 2020 Previous Trust/LHB Reference Number: N/A RESEARCH AUDIT Standard Operating Procedure Introduction and Aim As a legal Sponsor
More informationResearch Study Amendments
REFERENCE: VERSION NUMBER: 3.2 EFFECTIVE DATE: 05-02-18 REVIEW DATE: 05-02-20 AUTHOR: Clinical Trials Manager; Clinical Trials Officer REVIEWED BY: R&I Senior Team APPROVED BY: Deputy Director of Research
More informationSOP27: Standard Operating Procedure for Qualitative Components of Trials & other Rigorous Studies in Health & Social Care
SOP27: Standard Operating Procedure for Qualitative Components of Trials & other Rigorous Studies in Health & Social Care Lead Authors: Frances Rapport, Mel Storey, Alison Porter, Co-authors: Steve Allen,
More informationDate: 21 st May 2014 Version: 5 Page 1 of 11. Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May 2014
Date: 21 st May 2014 Version: 5 Page 1 of 11 STANDARD OPERATING PROCEDURE FOR MONITORING CLINICAL TRIALS (NWORTH 3.07) Approvals Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May
More informationConducting Clinical Trials of Investigational Medicinal Products
Title: Outcome Statement: Written By: Reviewed By: Conducting Clinical Trials of Investigational Medicinal Products Researchers in the Trust and research partners will be informed about the procedures
More informationOnce notified of the end of trial, a Research Manager, on behalf of the Sponsor, will contact the CI to arrange a close down monitoring visit.
1. INTRODUCTION This SOP has been produced in accordance with the requirements of The Medicines for Human Use (Clinical Trials) Regulations 2004, Medicines for Human Use (Clinical Trials) Amendment Regulations
More informationDate: 23 rd December 2014 Version 5 Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03)
Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03) Approvals Principal Author Name: D. Skelhorn Signature: D. Skelhorn Date: 22/12/2014 Quality Assurance Officer
More informationStandard Operating Procedure for Archiving
Standard Operating Procedure for Archiving SOP name: NWORTH07/19 archiving Version 2 Authorship Team: Angela Gliddon & Rhiannon Whitaker Meeting date reviewed 16 th April 2008 Designated NWORTH member
More informationStandard Operating Procedure
Standard Operating Procedure Number: UM/UoM TMF/SOP08/6.0 Title: The Creation and Maintenance of Trial Master Files and Essential Documentation Version: 6.0 () Effective Date: Author: Mrs Catherine Barrow
More informationSally Burtles, Director of Research Services & Business Development
Standard Operating Procedures (SOP) for: Process for Researchers - Amendments for Sponsored Studies (including halting studies and early termination) SOP Number: 17c Version Number: 2.0 Effective Date:
More informationInvestigator Site File Index (CTIMP)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol Current version plus all previous versions (or provide file note to detail location of previous
More informationSponsorship of Clinical Research Studies
Sponsorship of Clinical Research Studies Category: Summary: Equality Impact Assessment undertaken: Policy The UK Policy Framework for Health and Social Care 2017 (UKPF) and The Medicines for Human Use
More informationRD SOP32 Gaining MHRA Approval
RD SOP32 Gaining MHRA Approval Version Number: 1.0 Name of originator/author: Dr Lloyd Gregory Name of responsible committee: R&I Committee Name of executive lead: Medical Director & Director of Quality
More informationRDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs. Greater Manchester Mental Health NHS Foundation Trust
RDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs Greater Manchester Mental Health NHS Foundation Trust Title of Standard Operating Procedure: RDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs
More informationTrial Committees SOP Number: 47 Version Number: 2.0 Effective Date: 01/02/2017 Review Date: 01/02/2019
Standard Operating Procedures (SOP) for: Trial Committees SOP Number: 47 Version Number: 2.0 Effective Date: 01/02/2017 Review Date: 01/02/2019 Author: Reviewer: Reviewer: Authorisation: Name / Position:
More informationInvestigator Site File Index (Medical Devices)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol (Clinical Investigation Plan) Current version plus all previous versions (or provide file note
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number End of Study Notification and Premature Discontinuation of a Study SOP-RES-025 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016
More informationResearch Governance Policy
Research Governance Policy Version: Status: Title of originator/author: Name of responsible director: Developed/revised by group/committee and Date: Approved by group/committee and Date: Effective date
More informationSTUDY DOCUMENTS. DOCUMENT NO.: CR007 v4.0. Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 EFFECTIVE DATE: 21 MAR INTRODUCTION
STUDY DOCUMENTS DOCUMENT NO.: CR007 v4.0 AUTHOR: Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint office
More informationLouise Brook Clinical Trials Quality Monitor. Date
Details: Author: Louise Brook Clinical Trials Quality Monitor SOP Pages: 12 Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person
More informationStandard Operating Procedure. GCP Auditing of Research Studies
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-16-003 GCP Auditing of Research Studies SOP effective: 09 June 2017 Review date: 09 June 2019 SOP author signature: SIGNED COPY HELD WITHIN
More informationSTANDARD OPERATING PROCEDURE SOP 320. Developing a Research Protocol
STANDARD OPERATING PROCEDURE SOP 320 Developing a Research Protocol Version 2.1 Version date 26.03.2017 Effective date 26.03.2017 Number of pages 14 Review date April 2019 Author NNUH UEA Joint Research
More informationSTP Project Ethical Approval Process
STP Project Ethical Approval Process Introduction This document has been produced specifically for STP trainees who will undertake their University of Manchester Masters research project within the NHS.
More informationSTANDARD OPERATING PROCEDURE SOP 310
STANDARD OPERATING PROCEDURE SOP 310 DEVELOPMENT OF PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM Version 1.3 Version date 28.03.2017 Effective date 28.03.2017 Number of pages 8 Review date April
More informationTrial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products
1 Trial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products SECTION TITLE DOCUMENTS 1. Contact List Including details of relevant study site staff, responsible
More informationResearch Governance Policy and Procedure
Research Governance Policy and Procedure Version: 5 Name of originator/author: Name of executive lead: Date ratified: Review date: APPLICABLE TO: All staff. EXECUTIVE SUMMARY Dr Lisa Austin- University
More informationDevelopment Safety Update Report Guidance
Development Safety Update Report Guidance This document provides instructions for the preparation and submission of a Development Safety Update Report (DSUR) for a Clinical Trial of an Investigational
More informationEnd of Study Notification, Close-Out and Reporting Sponsored Research. Noclor/Spon/S11/01. SOP Reference ID:
End of Study Notification, Close-Out and Sponsored Research SOP Reference ID: Noclor/Spon/S11/01 Version Number 1.0 Effective Date: 6 th June 2016 It is the responsibility of all users of this SOP to ensure
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 17. Study Close Down
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 17. Study Close Down According to ICH Good Clinical Practice (GCP)
More informationRESEARCH IN HUMAN SUBJECTS OTHER THAN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS
Page 1 of 5 RESEARCH IN HUMAN SUBJECTS OTHER THAN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS After ethical review guidance for sponsors and investigators This document sets out important guidance
More informationPharmacovigilance and safety reporting for sponsored ATIMPs/CTIMPs
Joint Research Management Office (JRMO) Standard Operating Procedure (SOP) for: Pharmacovigilance and safety reporting for sponsored ATIMPs/CTIMPs SOP Number: 26a Version Number: 13.0 Effective Date: 31
More informationRecording, Managing and Reporting Adverse Events in the UK
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 informationStandard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Essential Documentation and Creation and Maintenance of Trial Master File SOP Number: 13 Version Number: 2.0 Supercedes:
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Non Compliance and Serious Breach Reporting SOP-RES-017 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov
More informationStandard Operating Procedure (SOP) for the Development, Management & Control of Research-Related SOPs
Standard Operating Procedure (SOP) for the Development, Management & Control of Research-Related SOPs For Completion by SOP Author Reference Number Version Document Author(s) Document Reviewer(s) PHT/RDSOP/001
More informationHow to Apply for Ethics (Non-CTIMPs) including Sponsorship
How to Apply for Ethics (Non-CTIMPs) including Sponsorship Joint Research & Enterprise Office (JREO) St George s University of London Lucy H H Parker Clinical Research Governance Manager Joint Research
More informationResearch Study Close-down and Archiving Procedures
Title: Research Study Close-down and Archiving Procedures Outcome Statement: To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.
More informationSTANDARD OPERATING PROCEDURE SOP 410. Set up and Initiation of an Investigator Site
STANDARD OPERATING PROCEDURE SOP 410 Set up and Initiation of an Investigator Site Version 1.2 Version date 4.01.2017 Effective date 5.07.2017 Number of pages 13 Review date July 2019 Author Role NNUH
More informationEthical Approval. Document Number: 012
Ethical Approval Document Number: 012 Version: 1 Ratified by: RFL Committee Date ratified: 03.06.2014 Name of originator/author: Directorate: Department: Name of responsible individual: Liba Stones, Manager
More informationIndex of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the March Please note that with effect from 2015, all SOPs and Appendices use the same
More informationConfirming Research Study Capacity and Capability
Title: Outcome Statement: Written By: Confirming Research Study Capacity and Capability Researchers will be informed about the procedures and requirements for obtaining permission to conduct a research
More informationHRA/Ethics Approval for Health-Related Research
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 informationStandard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies. SOP Number: UoA-NHSG-SOP-010 Version No: 2
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies SOP Number: UoA-NHSG-SOP-010 Version No: 2 Author: Date: 27 th March 2015 (Carole Edwards, Lead Research
More informationMHRA regulatory centre and Research Ethics Service (RES) combined ways of working pilot Instructions to sponsors (version 2.1)
MHRA regulatory centre and Research Ethics Service (RES) combined ways of working pilot Instructions to sponsors (version 2.1) Document purpose: The purpose of this document is to provide instructions
More informationStudy Files and Filing
Study Files and Filing The current version of all Hillingdon Hospital R&D Guidance Documents and Standard Operating Procedures are available from the R&D Intranet and Internet sites: www.ths.nhs.uk/departments/research/research.htm
More informationInvestigational Medicinal Product (IMP) Management Standard Operating Procedure
Reference Number: UHB 040 Version Number: 3 Date of Next Review: 26 Apr 2019 Previous Trust/LHB Reference Number: T 363 Standard Operating Procedure Introduction and Aim This procedure is written to support
More informationPhase 1 studies and The Over- Volunteering Prevention System (TOPS)
Research Department STANDARD OPERATING PROCEDURE Phase 1 studies and The Over- Volunteering Prevention System () SOP Number C129 Version Number 1.0 Date effective 18 June 2018 Author Luke Barron Related
More informationSOP04: Standard Operating Procedure for Trial Supplies and Labelling
SOP04: Standard Operating Procedure for Trial Supplies and Labelling Authorship Team: Anne Seagrove & Mair Roberts Joint SOP Group on Trial Administration (viz Angela Evans, Sarah Gaze, Hayley Hutchings,
More informationStandard Operating Procedure. GCP Auditing of Research Studies. SOP effective: 23rd January 2018 Review date: 23rd January 2020
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-16-005 GCP Auditing of Research Studies SOP effective: 23rd January 2018 Review date: 23rd January 2020 SOP author signature: Signed copy
More informationStandard Operating Procedure Research Governance
Research and Enterprise Standard Operating Procedure Research Governance Title: Development, Review and Amendment: Study Protocol SOP Reference Number: QUB-ADRE-002 Date prepared 28 May 2008 Version Number:
More informationIndex of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the October Please note that with effect from 2015, all SOPs and Appendices use the same
More informationRDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Product (CTIMPs)
RDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Greater Manchester Mental Health NHS Foundation Trust Title of Standard Operating Procedure: Document Summary: Document
More informationCOMMENTS FROM EUROPABIO GENERAL COMMENTS
SUBMISSION OF COMMENTS ON DETAILED GUIDANCE FOR THE REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES, NOTIFICATION OF SUBSTANTIAL AMENDMENTS
More informationThe EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Bulgaria
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Bulgaria Question 1: What laws or regulations apply to an application for conducting a clinical
More informationIMP Management and Accountability
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 informationSTANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH
STANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH Version 1.0 Version date 13.12.2016 Effective date 13.12.2016 Number of pages 9 pages Review date
More informationESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL
ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL THIS INFORMATION SHEET (ISR-RG-014) HAS BEEN TAKEN DIRECTLY FROM THE ICH- GUIDELINE* WITH ADDITIONAL COMMENTS ADDED BY THE RESEARCH GOVERNANCE
More informationStandard Operating Procedure. Vendor Management
REFERENCE: VERSION NUMBER: 2.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Clinical Trials Manager, Contracts & Quality Management Officer REVIEWED BY: Research & Innovation Group APPROVED BY:
More informationTrial oversight SOP for HEY-sponsored CTIMPs
R&D Department Trial oversight SOP for HEY-sponsored CTIMPs Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored in a retrieval system
More informationNRES Committee East of England - Cambridge Central Royal Standard Place Nottingham NG1 6FS
22 April 2015 NRES Committee East of England - Cambridge Central Royal Standard Place Nottingham NG1 6FS Professor Willem Ouwehand Wellcome Trust Sanger Institute, Honorary NHSBT Consultant in Haematology.
More informationWriting a Protocol for CTIMPs
REFERENCE: VERSION NUMBER: 4.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: REVIEWED BY: APPROVED BY: CONTROLLER: Clinical Trials Manager; Clinical Trials Officer Research & Innovation Group
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Creation & Maintenance of an Investigator Brochure SOP Number: 34 Version Number: 1.0 Supercedes: N/A Effective date: August
More informationWriting a Protocol to Good Clinical Practice (GCP)
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 informationMarie-Claire Rickard (RG and GCP Manager) Rachel Fay (RG and GCP Manager) Elizabeth Clough (R&D Governance Operations Manager)
Standard Operating Procedures (SOP) for: For researchers: Pharmacovigilance and Safety Reporting for Sponsored CTIMPs/ATMP SOP Number: 026a Version Number: 12.0 Effective Date: 21/4/16 Review Date: 21/4/18
More informationRESEARCH SUPPORT SERVICES FRAMEWORK. Streamlining the management and governance of R&D studies in the NHS
RESEARCH SUPPORT SERVICES FRAMEWORK Streamlining the management and governance of R&D studies in the NHS Page 1 of 22 Contents 1. INTRODUCTION... 3 How to use this document... 3 Background... 4 Purpose
More informationStandard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies. SOP Number: SOP-QA-9 Version No: 1
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies SOP Number: SOP-QA-9 Version No: 1 Author: Date: 1-9-15 (Carole Edwards, Lead Research Nurse, NHS Grampian)
More informationR&D Administration Manager. Research and Development. Research and Development
Document Title: Document Number: Trial Closure and End of Trial SOP021 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration
More informationThe EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Ireland
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Ireland Question 1: What laws or regulations apply to an application for conducting a clinical
More informationStandard Operating Procedure
Standard Operating Procedure Title: Clinical Site Monitoring Status: PRIVATE Author Name: Audrey Strader Approver Name: Christine Kubiak Document no.: CSM 02 Effective date: 11/01/2016 Review Date (if
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Archiving and the Destruction of Records SOP-RES-028 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January
More informationCombined trial of an investigational medicinal product and an investigational medical device
Welcome to the Integrated Research Application System IRAS Project Filter The integrated dataset required for your project will be created from the answers you give to the following questions. The system
More informationMarie-Claire Good, RG and GCP Manager James Rickard, Deputy Chief Pharmacist Technical Services Cheryl Lawrence, Senior Research Pharmacist
Standard Operating Procedures (SOP) for: IMP Management BH/QMUL Sponsored CTIMPs SOP Number: 42a Version Number: 3.0 Effective Date: 14 th August 2017 Review Date: 14 th August 2019 Author: Reviewer: Reviewer:
More informationDate : Date of start of procedure: Authorisation/ positive opinion :
Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use,
More informationRSC/CT Det. no. 1/2013
RSC/CT Det. no. 1/2013 Protocol 1631-P The English version of this Determination was prepared in order to help comprehension by non-italian mother tongue users, but is NOT an official document. Please
More informationSetting up new studies where NBT are sponsor
Setting up new studies where NBT are sponsor Task Why Task Should Happen When Task Should Happen Who Should Complete Task How Task is Completed TASK 1: Apply for confirmation that NBT can sponsor the study
More informationR&D Administration Manager. Research and Development. Research and Development. NHS Staff Trust-Wide THIS IS A CONTROLLED DOCUMENT
Document Title: Document Number: Research Protocol Design for Papworth Sponsored Studies SOP019 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by:
More informationSafety Reporting Part 1: For Clinical Trials of Investigational Medicinal Products (CTIMPs)
Part 1: For Clinical Trials of Investigational Medicinal Products (CTIMPs) Version 1.4 Effective date: 1 December 2011 Author: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision
More informationAPPLICATION FORM. Application for a Recognised Research Ethics Committee (REC) Opinion on a Clinical Trial on a Medicinal Product for Human Use.
APPLICATION FORM Application for a Recognised Research Ethics Committee (REC) Opinion on a Clinical Trial on a Medicinal Product for Human Use. Form 1 This application form should be completed and submitted
More informationCode break is also known as breaking the blind and involves un-blinding a participant so that the treatment allocation is made known.
1. INTRODUCTION This SOP has been produced in accordance with Medicines for Human Use (Clinical Trials) Regulations 2004. This SOP will outline the procedure for breaking the study code in a NUH sponsored
More informationDocument Title: Annual Progress Reports (APRs) Document Number: 056
Document Title: Annual Progress Reports (APRs) Document Number: 056 Version: 1 Ratified by: Committee Date ratified: 30/11/2017 Name of originator/author: Directorate: Department: Name of responsible individual:
More informationDocument Title: Site Recruitment and Initiation for Papworth Sponsored Studies
Document Title: Site Recruitment and Initiation for Papworth Sponsored Studies Document Number: SOP015 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For
More informationInspections: an academic perspective
Inspections: an academic perspective Patricia Henley Quality and Governance Manager Head, Research Governance & Integrity Office London School of Hygiene & Tropical Medicine Email: patricia.henley@lshtm.ac.uk
More informationSite Initiation and Activation
Site Initiation and Activation Clinical Trials SOP Reference ID: Noclor/Spon/S05/01 Version Number 1.0 Effective Date: 23 rd February 2016 It is the responsibility of all users of this SOP to ensure that
More informationScotland A REC 2 nd Floor Waverley Gate 2-4 Waterloo Place Edinburgh EH1 3EG
Scotland A REC 2 nd Floor Waverley Gate 2-4 Waterloo Place Edinburgh EH1 3EG Telephone: 0131-465-5679 19 February 2016 Professor Karim Brohi Professor of Trauma Science Queen Mary University of London
More informationREVISION OF THE CLINICAL TRIALS DIRECTIVE 2001/20/EC UK RESPONSE TO CONCEPT PAPER
REVISION OF THE CLINICAL TRIALS DIRECTIVE 2001/20/EC UK RESPONSE TO CONCEPT PAPER Introduction This letter provides the UK Government s response to the Commission s public consultation on the proposed
More informationManagement and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility Document Detail Document type Standard Operating Procedure CRF-STU-SOP-1: Management and Accountability
More informationDate : Date of start of procedure: Authorisation/ positive opinion :
Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use,
More informationStandard Operating Procedure. SOP effective: 23 July 2015 Review date: 23 July 2017
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-12-002 Archiving Clinical Research Documents SOP effective: 23 July 2015 Review date: 23 July 2017 SOP author signature: SIGNED COPY HELD
More informationStandard Principles for Operation. National Mutual Acceptance of Single Ethical and Scientific Review of Multi-centre Human Research Projects
Standard Principles for Operation National Mutual Acceptance of Single Ethical and Scientific Review of Multi-centre Human Research Projects Scope These Standard Principles for Operation (Principles) describe
More informationAuthor Signature: Date: 11 October 2017 The author is signing to confirm the technical content of this document
MELBOURNE CHILDREN S TRIALS CENTRE (MCTC) Guideline document title: Developing, amending and complying with research protocols Version: 2.0 Author: Melbourne Children s Trials Centre (MCTC) Author Signature:
More informationMRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council
MRC Clinical Trials Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 Medical Research Council MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 MRC GUIDELINES FOR
More informationVERSION: 21 st June Date of Publication: 15 th March C/ CAMPEZO, 1 EDIFICIO MADRID Tel.: Fax:
Memorandum on Collaboration and Exchange of Information between the Spanish Agency of Medicinal Products and Medical Devices and Ethics Committees for investigation with medicinal products VERSION: 21
More informationDraft proposal for an addendum, on transparency, to the Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014
20 January 2015 EMA/641479/2014 Compliance and Inspections Draft proposal for an addendum, on transparency, to the Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014
More informationGuide to Clinical Trial Applications
Guide to Clinical Trial Applications AUT-G0001-11 29 MAY 2018 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS ABBREVIATIONS 3 1
More information