GOOD CLINICAL PRACTICE TRAINING POLICY FOR PERSONNEL UNDERTAKING RESEARCH Reference No: UHB015 Version No: 2 Previous Trust / LHB Ref No: N/A Documents to read alongside this Policy, Procedure etc (delete as necessary) N/A Classification of document: Area for Circulation: Authors: Executive Lead: Group Consulted Via/ Committee: Ratified by: Research and Development UHB Wide Research & Development Director, Operational Director, Clinical Research Facility Research Governance Coordinator Medical Director Research Governance Group Quality and Safety Committee Version Number Date Published: Date of Review Reviewer Name 1 12/10/2010 Research Governance Group 2 20/05/14 Research Governance Group Completed Action New UHB Policy Approved By Quality & Safety Committee Date Approved New Review Date 12/10/2010 12/11/2013 Reviewed Xx/xx/xx Xx/xx/xx Disclaimer When using this document please ensure that the version you are using is the most up to date either by checking on the UHB database for any new versions. If the review date has passed please contact the author. OUT OF DATE POLICY DOCUMENTS MUST NOT BE RELIED ON Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 1 of 8 Version No. 2.0
Version Number Date of Review Approved Date Published Summary of Amendments 1 02/10/2012 18/11/10 New Procedure 2 Xx/xx/xx Xx/xx/xx Minor changes to reflect changed role of Operational Director of CRF and remove reference to Cardiff University where no longer appropriate. Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 2 of 8 Version No. 2.0
CONTENTS Page Number 1. Introduction 4 2. Statement 4 3. Scope of the Policy 4 4. Aims of the Policy 4 5. Objectives 5 6. Roles and Responsibilities 5 7. Who needs to undertake GCP training 5-7 8. Definition of GCP training 7 9. Resources 8 10. Implementation 8 11. Equality 8 12. Distribution 8 13. Audit and Review 8 Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 3 of 8 Version No. 2.0
1.0 INTRODUCTION All individuals undertaking clinical research must have knowledge and training to ensure that the rights and safety of participants in research are protected and that the results of clinical trials are credible and accurate. Participants in clinical research may be NHS patients, volunteers identified as suitable by their previous medical history or healthy volunteers. In particular, legislation governing the conduct of Clinical Trials of Investigational Medicinal Products (CTIMPs), namely, The Medicines for Human Use (Clinical Trials) Regulations Amendment 2006 (SI2006/1928) states that each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks In addition the Medicines and Healthcare products Regulatory Agency (MHRA) has stated that The frequency of training is not defined in the regulations, however, in accordance with Regulation 12, all staff must conduct the trial in accordance with the conditions and principles of Good Clinical Practice (GCP) defined in the legislation, hence the training should be given at intervals appropriate to ensure staff maintain current awareness of the UK Regulations and applicable European Guidelines. How often this training is repeated is a business decision for the organisation concerned. Appropriate updates should be provided when applicable procedures, guidance or legislation change. 2.0 STATEMENT It is the policy of Cardiff and Vale University Health Board that all staff involved in research undertake appropriate training. 3.0 SCOPE OF THE POLICY This policy applies to all personnel undertaking clinical research (including Clinical Trials of Investigational Medicinal Products (CTIMPs)) in the UHB, including those individuals: holding substantive or honorary contracts/titles with the UHB holding letters of access to UHB undertaking clinical research involving UHB patients; undertaking clinical research on UHB premises 4.0 AIMS Cardiff and Vale University Health Board (UHB) and has produced this policy document to define the type and frequency of GCP training that should be undertaken by any personnel working within the clinical research environment. Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 4 of 8 Version No. 2.0
5.0 OBJECTIVES This policy has been developed to ensure that All personnel involved in undertaking clinical research within the UHB, and others as described above, have undertaken appropriate Good Clinical Practice (GCP) training; Both UHB and Cardiff University (CU) provide GCP training opportunities to support this policy. Timescales for renewal of GCP training are identified 6.0 ROLES & RESPONSIBILITIES Responsibility for the implementation of this policy and the operational management of the provision of topic specific training will be overseen by a group of three individuals: one (1) representative from the Research, Innovation and Enterprise Services (RIES), Cardiff University; one (1) representative from the Research and Development Office, University Health Board and one (1) representative from the Clinical Research Facility (CRF). The strategic direction of the group will be set by the R&D Director and the R&D Senior Management Team. 6.1 Administrative Support Administrative support to the group will be provided by a member of the UHB R&D Office administrative team. This will include the maintenance of a record of the training undertaken which will be shared with RIES. 6.2 List of approved Training The UHB R&D Office will compile a list of courses which are recognised as meeting the required standards. This list can be accessed on the R&D Intranet pages. 6.3 Frequency of and venue for training sessions Training will usually be provided on a monthly basis for ten (10) months of the year (excluding August and January). Training will take place whenever possible, within the Seminar Room of the CRF, Upper Ground Floor C Block, University Hospital of Wales. 7.0 WHO NEEDS TO UNDERTAKE GCP TRAINING? Category 1: Staff conducting CTIMPs This category includes all staff conducting CTIMPs sponsored, co-sponsored or hosted by the UHB Chief Investigators Principal Investigators Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 5 of 8 Version No. 2.0
All staff with delegated responsibilities (as recorded on the study delegation log) Level of Training: Evidence of approved GCP training (usually a certificate of attendance/completion) is a mandatory requirement for all staff in Category 1 who are taking part in studies sponsored, co-sponsored or hosted by the UHB. Failure to meet this requirement will result in withdrawal of the sponsorship/co-sponsorship or withdrawal of R&D approval for hosted CTIMPs. There may be circumstances where individuals are only required to undertake topic related modules specific to their role. This should be discussed with the Sponsor and UHB R&D Office (depending on the researcher s substantive employer). Category 2: Chief/Principal Investigators of non-ctimps This category includes all Chief Investigators and Principal Investigators conducting non-ctimps i.e. studies that involve direct contact with participants or their data. Level of Training: Evidence of approved GCP training is a mandatory requirement for all Chief/Principal Investigators in Category 2 who are taking part in studies sponsored, co-sponsored or hosted by the UHB. It should be noted that some GCP training is focused exclusively on CTIMPs and individuals are advised to contact the course providers to determine if the course is suitable. Some providers (e.g. NISCHR CRC trainers) provide specialist non-ctimp specific training Category 3: Research staff This includes: all staff with delegated responsibilities on the study delegation log conducting non-ctimps; all staff who have contact with subjects of CTIMPs as part of their routine clinical work and who are responsible for delivery of protocol directed interventions and treatment. Level of Training: All staff in Category 3 will be required to undertake topic related training specific to their role although they are eligible to undertake full GCP training and are encouraged to do so in the interests of ensuring continuous quality improvement. It is the responsibility of the CI/PI to ensure that each member of the research team has the appropriate training, and their qualifications are documented and retained in the Investigator /Trial Site File and in the individual s training record. Category 4: Staff who are exempt from undertaking GCP training Whilst all staff involved in research are encouraged to undertake GCP training as part of their own professional development, staff whose sole contribution to Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 6 of 8 Version No. 2.0
a study protocol is limited to routine care (that is, the procedures that they undertake are the same as in standard clinical care and are not specific to the research protocol) need not undertake GCP training or be listed on the study delegation log (e.g. Radiology staff undertaking standard Chest X rays as part of study screening) External contractors who provide a service for a study (e.g. scanning in private hospitals) need not undertake GCP training or be listed on the study delegation log. 8.0 DEFINITION OF GCP TRAINING: GCP training should be updated and renewed every 2 years for all relevant researchers (as described by Categories 1 to 4). In the first instance, appropriate GCP training will include either: a) Attendance at a recognised GCP training seminar; or b) Completion of a recognised online GCP training course. Staff will be required to provide evidence (usually a certificate) of attendance/completion of GCP training. All individuals who have undertaken the face-to-face or online GCP training will be able to fulfil the subsequent requirement to renew their GCP training every two years in any of the following ways: 1. Attendance at a recognised GCP training seminar or 2. Completion of a recognised online GCP training course or 3. Attendance at a GCP update/refresher training seminar; or 4. Attendance at three topic specific training sessions, delivered as part of the joint UHB/CU training plan within a 2 year period. For researchers involved in CTIMPs one of the three sessions must include a mandatory overview seminar, which will be run twice yearly as part of the training plan. This is the equivalent of attending a 3hr GCP update training course every 2 years. Successful completion of three sessions within 2 years will entitle the researcher to a two year certification of GCP training. There may be circumstances where individuals are only required to undertake topic related modules specific to their role. This should be discussed with the Sponsor and UHB R&D Office. From time to time, the Sponsor and/or researcher s substantive employer may identify further specific training that an individual researcher should undertake. Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 7 of 8 Version No. 2.0
If this should occur, the requirements and reasons behind will be discussed with the researcher. 9.0 RESOURCES The personnel required to implement this policy have been identified within the workload of existing members of the UHB and CU research staff. In the longer term, investment will be required in a database to track researcher compliance with this policy. As part of the development of the all Wales Academic Health Sciences Collaboration, it is planned that an All Wales R&D management system will be procured which will hopefully provide a facility for this aspect of the policy. 10.0 IMPLEMENTATION AND REVIEW The operational team will meet twice annually to set up and monitor the programme. 11.0 EQUALITY An equality impact assessment has been carried out. No adverse impact has been identified. 12.0 DISTRIBUTION This policy will be made available on the UHB intranet and internet site. 13.0 AUDIT AND REVIEW This policy will be reviewed every three years or sooner if appropriate. The training programme will be reviewed by the R&D Director and the operational management team. In addition, feedback will be sought via consultation with the users of the programme to elicit areas that require improvement and to identify areas that might usefully be included in future programmes. A report and recommendations for any required alteration to the programme will be provided to the Research Governance Group annually Acknowledgement: This document was based upon a policy document produced by Lynda McSorley of the Glasgow Clinical Trials Unit and we are very grateful for her permission to use her work as a basis for this document. Issue date: xx/xx/xx UHB015 (PR-RG-001) Page 8 of 8 Version No. 2.0
Appendix 2 - Equality Impact Assessment - Standard Assessment Template Section A: Assessment Name of Policy: GOOD CLINICAL PRACTICE TRAINING POLICY FOR PERSONNEL UNDERTAKING RESEARCH Person/persons conducting this assessment with Contact Details Research & Development Department 2nd Floor, Tower Block 2, University Hospital of Wales Heath Park Cardiff CF14 4XW Date 19/08/14 1. The Policy Is this a new or existing policy? - It is an update to an existing Policy What is the purpose of the policy? - To ensure that the UHB lays out the GCP requirements and has appropriate training available in place for individuals undertaking research within the organisation How do the aims of the policy fit in with corporate priorities? i.e. Corporate Plan - The aims of this policy fit under the corporate priority of - Governance - To have effective governance arrangements ensuring the UHB is compliant with relevant legal and regulatory frameworks and its processes for decision making are robust. Who will benefit from the policy? - Those undertaking research within UHB will benefit, as they gain the knowledge and understanding to undertake their research within Good Clinical Practice (GCP) requirements, and patients/staff participating in research will benefit as it ensures their researcher has appropriate GCP training. In addition the UHB as an organisation will benefit as this policy will ensure the organisation is in compliance with the legislation. What outcomes are wanted from this policy? - Only those appropriately trained to undertake research should be able to do so. GCP EQIA Page 1 of 9 Quality Safety and Experience Committee
Are there any factors that might prevent outcomes being achieved? - Financial resources for R&D Office to fund external GCP trainers. Personnel are able to complete the training online, but they may need to cover the cost themselves, dependent on which training resource is used. 2. Data Collection What qualitative data do you have about the policy relating to equalities groups (e.g. monitoring data on proportions of service users compared to proportions in the population)? There was no specific equalities data available. Active researchers will need to comply with this policy, and a project s approval process is via a National Portal (NISCHR PCU).. Researchers would access this portal by completing an on line application form (IRAS) and upload relevant documents. The IRAS form does not require the researcher to state their ethnicity. An action will be to question NISCHR PCU as to whether they have considered a question regarding the protected characteristics. What quantitative data do you have on the different groups16 (e.g. findings from discussion groups, information from comparator authorities)? Data was collected relating to the ethnicity and disability of our staff. Please indicate the source of the data gathered? (e.g. Concerns/Service/Department/Team/Other) What gaps in data have you identified? (Please put actions to address this in your action plan?) Reference was made to the Equality Impact Assessment undertaken for the Recruitment and Selection Policy for which data had been gathered from the workforce profile of the Cardiff & Vale UHB and information was obtained from NHS Jobs. In addition data on GCP training within this organisation was obtained. April 2010-March 2011 264 attendees April 2011-March 2012-221 attendees April 2012-March 2013-319 attendees April 2013-March 2014-466 attendees April 2014 date 151 attendees It can be seen that the figures vary from year to year and these numbers will also include a number of researchers employed by Cardiff University. GCP EQIA Page 2 of 9 Quality Safety and Experience Committee
The trainer will need to familiarise themselves with equality issues. We found no evidence of any impact. We have undertaken an internet based search and we believe that the policy is consistent with policy statements from other NHS organisations. The following Google searches took place on 19 th August 2014. https://www.google.co.uk/search?q=good+clinical+practice+%28gcp%29+training+policy&hl=en-gb&gbv=2&oq=&gs_l= We found that Cambridgeshire and Peterborough NHS Foundation Trust s policy is that all staff working on clinical trials should undertake good clinical practice training. The North West London Hospitals state Staff involved and conducting Clinical trials must have GCP training. Hampshire Hospitals...state everyone involved in the conduct of clinical research must have training to ensure they are best prepared to undertake their responsibilities. https://www.google.co.uk/search?q=good+clinical+practice+training+policy+for+personnel+undertaking+research+equalit y+impact+assessment&hl=en-gb&gbv=2&oq=&gs_l= Sandwell and West Birmingham Hospitals NHS Trust found no impact in their EQIA 3. Impact Please answer the following Consider the information gathered in section 2 above of this assessment form, comparing monitoring information with census data as appropriate (see www.ons.gov.uk Office National Statistics website) and considering any other earlier research or consultation. You should also look at the guidance in Appendix 1 with regard to the protected characteristics stating the impact and giving the key reasons for your decision. We found no evidence of any impact. The Policy applies to all those undertaking Clinical Research in UHB in accordance with the role that they perform. Within these roles it applies equally to all relevant staff, and this is consistent with the google searches.. Do you think that the policy impacts on people because of their age? (This includes children and young people up to 18 and older people) - No, the policy is consistent in that it applies to those undertaking Clinical Research in UHB in accordance with GCP EQIA Page 3 of 9 Quality Safety and Experience Committee
the role that they perform. The policy does not impact upon people because of their age as it should not affect their ability to read and understand the policy. Do you think that the policy impacts on people because of their caring responsibilities? - No the policy does not impact upon people because of their caring responsibilities. It is an administrative document which does not impact on the individual working arrangements for staff. Do you think that the policy impacts on people because of their disability? Yes Documents are not automatically published in Braille or languages other than English. The primary source of circulation is via the intranet. Software which will read the policy for the reader is now very common therefore documents should generally be accessible to those with a visual impairment. Do you think that the policy impacts on people because of Gender reassignment? - No, No the policy does not impact upon people because of gender reassignment. It is an administrative document which does not impact on the individual working arrangements for staff. Do you think that the policy impacts on people because of their being married or in a civil partnership? - No the policy does not impact upon people because of their being married or in a civil partnership. It is an administrative document which does not impact on the individual working arrangements for staff. Do you think that the policy impacts on people because of their being pregnant or just having had a baby? No,the policy does not impact upon people because of their being pregnant or just having had a baby. It is an administrative document which does not impact on the individual working arrangements for staff. Do you think that the policy impacts on people because of their race? - No, the policy is consistent in that it applies to those undertaking Clinical Research in UHB in accordance with the role that they perform Do you think that the policy impacts on people because of their religion, belief or non-belief? - No, the policy does not impact upon people because of their religion, belief or non belief. It is an administrative document which does not impact on the individual working arrangements for staff. Do you think that the policy impacts on men and woman in different ways? - No, the policy does not impact upon men and women in different ways. It is an administrative document which does not impact on the individual working arrangements GCP EQIA Page 4 of 9 Quality Safety and Experience Committee
for staff. The policy is consistent in that it applies to all those undertaking Clinical Research in UHB in accordance with the role that they perform. Do you think that the policy impacts on people because of their sexual orientation? - No, the policy does not impact upon people because of their sexual orientation. It is an administrative document which does not impact on the individual working arrangements for staff. Do you think that the policy impacts on people because of their Welsh language? - The policy is consistent in that it applies to those undertaking Clinical Research in UHB in accordance with the role that they perform, however, due to the specialty of the subject, there are no accredited Welsh Language GCP course providers within Wales or UK at this present time. 4. Summary. We consider there to be no impact as the Policy applies to all those undertaking Clinical Research in UHB in accordance with the role that they perform. Within these roles it applies equally to all relevant staff. GCP EQIA Page 5 of 9 Quality Safety and Experience Committee
Appendix 3 Cardiff and Vale University Health Board Action Plan Section B: Action 5. Please complete your action plan below. Issues you are likely to need to address include What consultation needs to take place with equality groups (bearing in mind any relevant consultation already done and any planned corporate consultation activities?) What monitoring/evaluation will be required to further assess the impact of any changes on equality target groups? Equalities Impact Assessment Implementation Mitigation/Action Plan Issue to be addressed Responsible Officer Action Required Timescale for completion Action Taken Comments Further consultation on the GCP training Policy to be undertaken with the UHB Research Governance Group and the Welsh Language Officer of the UHB Ratification of GCP Training Policy and EQIA by Quality and Safety Committee E mail NISCHR PCU as to whether they have considered a question regarding the protected characteristics. Pat Tamplin Pat Tamplin EQIA to be circulated to members for consultation Policy & EQIA to submitted to Quality and Safety Committee 02/9/14 Consultation undertaken 4/9/14 Policy & EQIA to submitted to Quality and Safety Committee Pat Tamplin E mail 02/09/14 E mail sent GCP EQIA Page 6 of 9 Quality Safety and Experience Committee
6. Report, publication and Review Please record details of the report or file note which records the outcome of the EQIA together with any actions / recommendations being pursued (date, type of report etc) It will be published on Appendix 4 of this document, which is the Format for publication of EQIA results - Executive Summary There is no evidence of any impact as the Policy applies to all employees in accordance with the role that they perform. Within these roles it applies equally to all relevant staff. Please record details of where and when EQIA results will be published The EQIA will be published on the Cardiff and Vale UHB Intranet, in parallel to the GCP Policy. Please record below when the EQIA will be subject to review. In 3 years time by the Research Governance Group Name of person completing _Pat Tamplin Signed _ Pat Tamplin Date: 19/08/14 Name of Responsible Executive/Clinical Board Director Authorising Assessment and Action Plan for publication Dr Graham Shortland Medical Director Signed: Date: GCP EQIA Page 7 of 9 Quality Safety and Experience Committee
Appendix 4 Format for publication of EQIA results Executive Summary A number of Google searches took place on 19 th August 2014 and we found that Cambridgeshire and Peterborough NHS Foundation Trust s policy is that all staff working on clinical trials should undertake good clinical practice training. The North West London Hospitals state Staff involved and conducting Clinical trials must have GCP training. Hampshire Hospitals state everyone involved in the conduct of clinical research must have training to ensure they are best prepared to undertake their responsibilities. Sandwell and West Birmingham Hospitals NHS Trust found no impact in their EQIA We consulted with the UHB Research Governance Group Members and the UHB Welsh Language Officer. We believe there is no evidence of any impact as the Policy applies to all employees in accordance with the role that they perform. Within these roles it applies equally to all relevant staff. Background The Policy aims to ensure that the UHB lays out the GCP requirements and has appropriate training available in place for individuals undertaking research within the organisation The context in which the policy operates The Policy operates within the context of Clinical Research Undertaken within UHB. Who was involved in the EQIA? Senior Research and Development staff members and Research Governance Group, as well as the UHB Welsh Language Officer The scope of the EQIA In line with current Legislation and Frameworks, appropriate GCP training has to be completed, for all persons who undertake Clinical Research. The Policy sets out the level of training within different roles in research. A Google search was performed to try to identify any impacts of similar Policies on Equality, and no impacts were found. The data sources and information used The consultation that was carried out (who with, how and a summary of the responses). Consultation on the GCP training Policy was undertaken with the UHB Research Governance Group and the Welsh Language Officer. The Welsh Language Officer drew our attention to the Welsh language Act. No other comments were received GCP EQIA Page 8 of 9 Quality Safety and Experience Committee
Key findings We found no evidence of any impact since the policy is consistent and applies to everyone involved in research within Cardiff and Vale University Health Board and the policy is consistent with those in other NHS organisations. Recommendations We found no evidence of any impact since the policy is consistent and applies to everyone involved in research within Cardiff and Vale University Health Board. NISCHR PCU has been e mailed to ask if they have considered a question regarding the protected characteristics. State any recommended changes to the proposed policy as a result of the EQIA and plans for implementation/monitoring/review. Both the Policy and the EQIA will be reviewed in 3 years time, or sooner if new evidence presents, to ascertain if there has been any new impact. Any impacts will be considered by the Research Governance Group. Effectiveness of procedure and its impact will be monitored by reviewing lessons from any incidents or complaints. GCP EQIA Page 9 of 9 Quality Safety and Experience Committee