Joint R&D Support Office SOP C-2005 UHL. Training for all Staff Engaged in Research conducted in the University Hospitals of Leicester NHS Trust

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1 UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES Joint R&D Support Office SOP C-2005 UHL Training for all Staff Engaged in Research conducted in the University Hospitals of Leicester NHS Trust PCG Registration C21/2013 OFFICE BASE Joint Research and Development Support Office Research & Development Leicester General Hospital Gwendolen Road Leicester LE5 4PW

2 Standard Operating Procedure: SOP C-2005 UHL Training for all Staff Engaged in Research conducted in the University Hospitals of Leicester NHS Trust Research & Development April Introduction This Standard Operating Procedure (SOP) describes the minimum additional training requirements for personnel involved in research. Personnel must be appropriately qualified by training, experience and education to undertake their responsibilities in respect of the research activity competently, be trained in the study protocol, understand the trial and disease area well enough to explain the trial to subjects and be deemed competent in the pharmacological aspects of the study where applicable. To ensure implementation of the International Conference for Harmonisation in Good Clinical Practice Guidelines (ICH GCP) and compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 staff required to undertake ICH GCP must refresh their training every 2 years. Good Clinical Practice training underpins the principles of Good Clinical Practice to be followed for all clinical trials to ensure: Rights and well-being of clinical trial participants Resulting data are valid In addition, all personnel who wish to receive consent from subjects for research who are not medically qualified, need to undertake consent training every two years, with the exception of focus groups, self completion questionnaires, surveys or use of anonymous data / tissue studies. Please refer to the SOP C-2001 UHL Informed Consent for Research. 2. Procedure Where required evidence of a GCP Training Certificate must be provided for all research applications however, if you have submitted several applications for Research and Development (R&D) approval certificates valid within two years are accepted. Certificates provided from other organisations are accepted, provided assurances can be provided that the training incorporated the Principles of GCP, Informed Consent, Safety, Adverse Events and documentation. GCP Training Sessions UHL GCP training sessions are delivered both in a classroom and electronic format. Both sessions cover the principals of ICH-GCP, informed consent, safety, adverse events and trial documentation. It is recommended that for those who have not undertaken research previously, or have not previously attended a face-to-face session the classroom option is taken. The electronic format is ideal as a refresher for those who have existing practical experience in research and in applying the principles of GCP. GCP Training is MANDATORY for the following: All study personnel conducting research using Investigational Medicinal Products All study personnel conducting research using devices with or without a CE Mark Study personnel conducting qualitative interviews Sampling and any type of invasive intervention SOP C-2005 Training for Staff Engaged in Research conducted in the University Hospitals of Leicester NHS Trust Page 2of 5

3 GCP Training is RECOMMENDED only and not mandatory for the following: Study personnel handing out Self Completion Questionnaires or are a Local Collaborator Studies involving the use of Surveys, Use of Anonymous Data or Tissue For the next available session visit UHL E-Learning to book on to a course. e-uhl can be accessed via insite or from external computers via the following link: Guidance Consent Training ICH-GCP confirms that the (PI) has overall responsibility for the consent process. However other suitably qualified and trained professionals can receive informed consent for the research study provided that the Sponsor and CI agree. All personnel who wish to receive consent from subjects for research and who are not medically qualified, need to complete consent training (see SOPC-2001 UHL Informed Consent for Research) with the exceptions of focus groups, self completion questionnaires, surveys or use of anonymous data / tissue studies. This certificate is valid for two years from the date of certification. Additionally they must hold a valid GCP certificate and have been approved for the study role by R&D Those wishing to receive consent must be employed by the Trust or hold an Honorary Contract / Honorary Research Contract or a Letter of Access with UHL. Training in Trial Specific Standard Operating Procedures and Pharmacological Aspects of Trial Research activities have the potential to generate unique training needs. Staff involved must be trained appropriately to carry out the requirements of the Protocol An may need to consider providing training in the following to enable study teams to follow the protocol and facilitate recruitment: Training in the most recent version of the protocol Training in relevant Standard Operating Procedures if required Training in the use of devices, particularly if they are novel or being used unconventionally Training in the pharmacological aspects of a study, with support from pharmacy especially where an investigational medicinal product is being used Confirmation that the relevant SOPs have been read and understood by individual study team members must be filed in the Site File 3. Responsibilities Responsibility Undertaken by Activity To maintain the Delegation of Authority and Signature Log in the Trial Master File. To make sure all s and staff working on the study are GCP trained and consent assessed as appropriate. To ensure that all members of staff have been approved by R&D for their assigned study role To ensure that all members of staff have been approved by R&D for their assigned study role SOP C-2005 Training for Staff Engaged in Research conducted in the University Hospitals of Leicester NHS Trust Page 3of 5

4 Responsibility Undertaken by Activity To keep copies of all training records and assessment proformas in the Site File. To update themselves and all members of their research team in all aspects of the trial, including consent, GCP, standard operating procedures and pharmaceutical products (as appropriate). To identify additional training needs of staff involved in research. Ensure that they carry out only those tasks for which they have been delegated Research Research Team Members Team Members 9. R&D Office R&D Office Assure qualification of named investigators by checking CVs, certification and assessment proforma as part of R&D approval. 10. R&D Office R&D Office To provide GCP training and consent assessment in partnership with investigators. 4. Legal Liability Statement Guidelines or Procedures issued and approved by the Trust are considered to represent best practice. Staff may only exceptionally depart from any relevant Trust guidelines or Procedures and always only providing that such departure is confined to the specific needs of individual circumstances. In healthcare delivery such departure shall only be undertaken where, in the judgement of the responsible healthcare professional it is fully appropriate and justifiable such a decision to be fully recorded in the patient s notes and in the research site file. This table is used to track the development and approval of the document and any changes made on revised / reviewed versions Author / Lead Officer: Reviewed by: Approved by: DEVELOPMENT AND APPROVAL RECORD FOR THIS DOCUMENT Julie James Job Title: UHL Clinical Trials Monitor and Trainer R&D Management Meeting Date Approved: 27/06/2013 REVIEW RECORD Date Issu e Num ber Reviewed By Description Of Changes (If Any) DISTRIBUTION RECORD: Date Name Dept Received SOP C-2005 Training for Staff Engaged in Research conducted in the University Hospitals of Leicester NHS Trust Page 4of 5

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