STANDARD OPERATING PROCEDURE

Transcription

1 STANDARD OPERATING PROCEDURE Title Reference Number Training and Development SOP-QMS-007 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s) Teresa O Leary, Head of Regulatory Compliance Melanie Boulter, QA Auditor Authorisation (Original signatures are retained by Research & Innovation) Dr Stephen Ryder Director of Research & Innovation Dr Stephen Fowlie Medical Director 04 Apr Apr 2016 USERS OF THIS STANDARD OPERATING PROCEDURE MUST REFER TO TO ENSURE THE MOST CURRENT VERSION IS BEING USED

2 Page 2 of 9 1. Document History Version Issue Date Reason for Change Number 1 30 th May 2014 Original SOP. Replaces SOP-19. Updated due to actions from CAPA 15/04 and 2 15 Apr 2016 biennial review

3 Page 3 of 9 2. Introduction The Medicines for Human Use (Clinical Trials) Regulations 2004 states that each individual involved in conducting a trial shall be qualified by education, training and experience. The Council Directive 93/42/EEC on Medical Devices (MDD) (1993) states the devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include: Consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users). Therefore, for NUH sponsored clinical trials of investigational medicinal products (CTIMPs) and clinical medical devices (CMD) appropriate training of research staff must be ensured. 3. Purpose and Scope The purpose of this standard operating procedure (SOP) is to describe the training processes and training requirements which apply to NUH R&I sponsored research. This SOP applies to NUH R&I staff and research teams involved in sponsored CTIMPs and CMD studies. 4. Responsibilities Sponsor (fulfilled by the Research and Innovation (R&I) department on behalf of NUH as sponsor) Sponsor and Chief Investigator (CI) or Principal Investigator (PI) will be responsible for ensuring all members of their research team have adequate levels of training for the studies they are working on. Research and Innovation (R&I) Head of Regulatory Compliance Ensures GCP processes are implemented through standard operating procedures and are managed through documentation control process. Responsible for the training management and maintains the role based training matrix.

4 Page 4 of 9 5. Definitions CI CRN CV GCP HR HRA ISF NIHR NUH PI QA R&I RPM SOP TMF Chief Investigator Clinical Research Network Curriculum Vitae Good Clinical Practice Human Resources Health Research Authority Investigator Site File National Institute for Health Research Nottingham University Hospitals NHS Trust Principal Investigator Quality Assurance Research and Innovation Research Project Manager Standard Operating Procedure Technical Master File

5 Page 5 of 9 6. Procedure 6.1 Training Management Role based training is managed through a training requirements matrix. The training matrix is managed by the Head of Regulatory Compliance (HRC) and is a controlled document (password protected). Within the training matrix, all NUH R&I and research team roles are identified and a set of training requirements assigned to each role. Addition or removal of any role or training requirement is controlled by the HRC. The training methods on the R&I induction programmes and SOPs are defined as Awareness (A) and Read & Understand /Classroom (Y), and are role based. Training effectiveness for classroom training is managed through training provider certification. Training is assessed through audits, study monitoring and reported to R&I management through QA metrics. 6.2 NUH R&I Staff New Staff All new R&I staff members must attend the required NUH corporate induction. The R&I specific research induction and safety training is mandatory and is arranged by the HRC. Each R&I line manager must inform the HRC of new inductees start dates in order to schedule this training. The new member of staff must complete the required R&I SOP training within the first month of starting. R&I staff directly involved in CTIMPs and CMD studies must complete the required GCP training which is facilitated by the National Institute for Health Research (NIHR). This training requirement is managed by each individual and is recorded in personal training folders. The HRC will provide the booking information to the new employee.

6 Page 6 of Refresher Training All R&I staff members must complete refresher NUH corporate training on a yearly basis (birth month). The R&I safety training is an annual refresher training and is completed within 12 months of the last training session. This is managed and arranged by the HRC. GCP refresher training is completed every two years and facilitated by the NIHR. This training requirement is managed by each individual and is recorded in personal training folders New Training Requirements Updated training requirements e.g. revised SOPs will be issued for training by the HRC. All R&I staff are responsible for ensuring they have completed all the required training as per the training matrix Classroom Training For R&I delivered classroom training, attendance must be recorded using the training attendance log (TAFQ00803) or the service provider training attendance form. The attendance logs are stored in a dedicated classroom training folder located with the HRC/QAA office SOP Training SOP training must be recorded using the SOP signature log (TAFQ00701). The SOP signature logs are stored in the master SOP folders located with the HRC/QAA office. The process for SOP review, approval and training is detailed with SOP_QMS_ R&I Personnel Training Folders Each member of R&I team are allocated with a dedicated personal training folder. This folder contains the following: Recent CV (signed and dated) (HRA template); GCP or other research/regulatory training certification; Role specific training and certificates; Current job description (signed by the employee and their line manager). For leavers, the personal training folder content will be archived within the individual s HR file.

7 Page 7 of Research Study Training (CTIMPs and CMDs) Research studies (CTIMPs and CMDs) The research team involved in the study must complete R&I induction training, this is only required for research personnel new to clinical research. The research team involved in the study must complete R&I safety reporting training, this is only required for research personnel new to clinical research. Prior to sponsorship authorisation of a study, up to date CVs (using HRA template) must be provided to the sponsor (NUH R&I) to ensure CI/PI and research teams have the appropriate clinical research skills. All research staff must complete GCP training or have valid GCP training certification. The R&I RPM must issue the training matrix and SOPs (applicable) to the CI/PI (to each PI when multi-site) along with the SOP signature logs (TAFQ00701). The CI/PI must then ensure all the mandatory training is completed and training is recorded in the SOP signature logs. The signed SOP signature logs must be filed within ISF (Investigator Site File) and a copy provide to sponsor for filing in the Technical Master File (TMF) Research Teams (Others) For research studies which are not classed as CTIMPs or CMDs, R&I SOP training is not dependant on the risk of the study and should be assessed as part of the risk assessment process (SOP-RES-002). However, for studies requiring informed consent training on SOP-RES-015 should be completed by the CI/PI and research teams involved in patient consent Site Initiation Visit (SIV) During initial study setup a site initiation training session will performed and recorded by the R&I RPM. This session will provide an overview of the mandatory requirements to conduct and manage the research study. During the SIV, the R&I RPM will verify that all mandatory SOP, GCP and any other required training has been completed. Until such training has been verified, the research cannot commence. Delegated activities must be proportional to the training and skills of the individual i.e. no one should perform research activities without the appropriate training.

8 Page 8 of Training Records All training records e.g. GCP Certs, CVs, SOP signature logs must be stored within the ISF (Investigator Site File) and copies filed in the TMF (Trial Master File). Training records which are superseded must be marked as such and retained within ISF and/or TMF. All ISFs and TMFs will be archived according to SOP_RES_ New or Revised Mandatory SOP Training New or revised SOPs will be issued for training to the CI/PI along with the training matrix. The CI/PI is responsible for ensuring the research team complete the training within the training period i.e. 30 working days. If training is not completed within the training period, no research activity related to the new/revised SOP must be performed. The CI/PI must store training records within the ISF and provide copies to the R&I RPM for filing in the TMF. The R&I RPM will review training completion through monitoring CTU Managed Studies For NCTU (Nottingham Clinical Trials Unit) managed studies, the Trial Manager is responsible for ensuring training is completed and up to date. R&I research induction training is not mandatory for NCTU managed trials however, this can be performed if requested. For non CTIMP and low risk medical devices trials, the NCTU Trial Manual will act as the official procedure for research management and conduct. This must be agreed with NUH R&I as sponsor. Where the Trial Manual and the Sponsor (NUH R&I) SOPs are required, the Trial Manager will be issued with the training matrix and SOPs by the R&I RPM. The Trial Manager is responsible for ensuring training is recorded. Training records must be stored in the ISF and NCTU TMF with copies provided to the R&I RPM for recording in the TMF.

9 Page 9 of 9 7. References and Associated Documents Research Governance Framework for Health and Social Care: Second Edition, 2005 The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments International Conference on Harmonisation Guidelines for Good Clinical Practice E6 (R1) The Medical Devices Regulations 2002 and subsequent amendments ISO Clinical Investigation of Medical Devices for Human Subjects TAFQ00701 SOP-QMS-001 SOP-QMS-002 SOP-RES-002 SOP-RES-015 SOP_RES_028 CV Standard Operating Procedure Signature Log Preparation, Review and Approval of Standard Operating Procedures Document Version Control Risk Assessment Informed Consent Archiving and Destruction of Records Curriculum Vitae Template from the HRA website