SOP Number: SOP-QA-34 Version No: 1. Version Description of Changes Date Effective. Change of number for Q-Pulse (Replaces UoA-NHSG-SOP-051 V1)

Transcription

1 Standard Operating Procedure: SOP Number: SOP-QA-34 Version No: 1 Author: Date: (Carole Edwards, Lead Research Nurse, NHS Grampian) Approved by: Date: (Professor Julie Brittenden, R&D Director, NHS Grampian) Approved by: Date: (Professor Steve Heys, Head of School, University of Aberdeen) Issue Date: Effective Date: Review Due Date: Document History: Version Description of Changes Date Effective 1 Change of number for Q-Pulse (Replaces UoA-NHSG-SOP-051 V1) This SOP will be reviewed at least every 3 years from initial and subsequent issue dates. Page 1 of 6

2 PURPOSE/INTRODUCTION NHS Grampian (NHSG) and University of Aberdeen (UoA) have the responsibility for developing and promoting a high quality research culture and for ensuring that staff employed in research are supported in, and held to account for, the professional conduct of research and this is enabled by requiring research staff to undergo Good Clinical Practice (GCP) training at a level commensurate with their role. GCP training is one component of the systems in place to ensure high quality research. Researchers are required to maintain awareness of current standards through GCP training, reference to published guidance, relevant policies and legislation. Researchers in both NHSG and UoA undertaking studies that involve human participants; healthy volunteers, patients, staff, (including their tissue and clinical data) undertake to abide by the principles of the Research Governance Framework for Health & Community Care, which covers GCP, and they also take responsibility for ensuring that staff involved in the research are familiar with the Research Governance Framework. For Clinical Trials of Investigational Medicinal Products (CTIMPs) adherence to the principles of GCP is incorporated into UK legislation. The UK Clinical Trials Regulations (SI 2004/1031, as amended) states that no person shall conduct a clinical trial otherwise than in accordance with the conditions and principles of GCP (Regulation 28) and that each individual involved in conducting a trial shall be qualified by education, training and experience to perform these tasks (Schedule 1, Part 2, 2). The regularity of training is not defined in the legislation. This SOP covers the frequency and level of GCP training required by NHSG and UoA. This is to ensure research is conducted to the international standard, that it safeguards participants, and attests to the quality of both the conduct of the study and the integrity of the resulting data. 2. SCOPE This SOP is relevant to University of Aberdeen and/or NHS Grampian researchers & staff undertaking studies involving human participants; healthy volunteers, patients and staff, (including tissue and data). This SOP may also be used by staff from other NHS areas, or organisations, with prior permission. 3. RELATED DOCUMENTATION SOP-QA-4 SOP-QA-2 Applying for Sponsorship for CTIMPs and High Risk Interventional Studies Establishing and Maintaining a Training Record Page 2 of 6

3 TMP-QA-22 Employee Training Record CV 4. REFERENCES 4.1 Scottish Executive Health Department Research Governance Framework for Health and Community Care 2006 Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031) as amended. Current versions of these documents can be accessed via the Clinical Research Governance and Quality Assurance Website: It is assumed that by referencing the principal regulations, all subsequent amendments made to the principal regulations are included in this citation. 4.2 ABBREVIATIONS AND DEFINITIONS CI (Chief Investigator) CTIMP CSOG Good Clinical Practice Delegation log High Risk Studies NHSG PI (Principal Investigator) Recognised GCP Training TMF UoA Valid GCP Training: The investigator who has overall responsibility for the clinical research study (single or multi-centre study). Clinical Trial of Investigational Medicinal Products as Defined by the Medicines for Human Use (Clinical Trials) Regulations Clinical Studies Oversight Group GCP is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical research projects that involve the participation of human subjects. The record of delegated responsibilities filed in the Study Site File and/or the Trial Master File. Study defined as high risk after completion of Risk Assessment by Research Governance Team NHS Grampian The investigator who has responsibility for the conduct of a trial at a particular NHS site or Board. The Training Team will advise which courses are currently recognised and relevant to researchers Trial Master File University of Aberdeen Attendance at a recognised & relevant GCP training course within the previous 2 years 5. RESPONSIBILITIES Page 3 of 6

4 It is the responsibility of the Research Governance Manager, or delegate, to ensure that the Chief Investigator/Principal Investigator (CI/PI) has evidence of valid GCP training prior to sponsorship being given for CTIMPs and High Risk Studies. It is the responsibility of the CI/PI to ensure that they and their study team have relevant GCP training that is commensurate with their role in the study. For CTIMPs and High Risk studies this must be updated 2-yearly. It is the responsibility of the CI/PI to ensure that they and their study team are named on a Delegation Log and that evidence of appropriate GCP training is available. It is the responsibility of the NHSG Training Team to ensure that local and online GCP courses are available. PROCEDURE Category 1: CTIMPs or classified High Risk Studies NHSG and UoA require that evidence of attendance/certification at a recognised GCP training* course for CTIMP research is available every 2 years or after major changes in clinical trial legislation (whichever is first). For both sponsored and hosted studies, staff working on the study must be named on a Delegation Log and documented evidence of GCP training, commensurate with the role they have in the study, is available. If a research activity is part of a person s normal clinical role and all other protocol activities are undertaken by a member of the research team, then no GCP training may be required, however this should be reviewed as part of the risk assessment for a trial and confirmed with the Sponsor. Sponsorship For research involving CTIMPs or classified High Risk Studies and sponsored or cosponsored by NHSG and/or UoA, evidence of valid GCP training for the CI and any local co-investigators will be checked on receipt of application for sponsorship. If no valid evidence available, the CI/PI will be directed to the Training Team who will offer appropriate training courses. Sponsorship of new CTIMPs or High Risk Studies will not be given if the CI does not have valid GCP training. GCP training will be checked during monitoring visits to ensure that it is up-to-date so that sponsorship can continue Page 4 of 6

5 6.2.4 For locally sponsored multi-centre studies it is the responsibility of the CI or delegate to ensure that the PI and all relevant research staff at Sites are suitably GCP trained and that documented evidence is kept. If the PIs at sites do not comply, the CI or delegate must escalate the non-compliance to Sponsor R&D Permission a) For research involving CTIMPs that are locally sponsored, evidence of valid GCP training for the CI/PI will be checked on receipt of application for R&D Permission. If no valid evidence available, the CI/PI will be directed to the Training Team who will offer appropriate training courses. b) R&D Permission will not be withheld if there is no valid GCP training at the time of permission but the Sponsor will be informed so that a decision can be made regarding study commencement. c) If during the course of monitoring or audit, poor research practice is noted in hosted studies, the R&D office will be informed and GCP or other targeted training offered to the CI/PI. If training not undertaken, the Quality Assurance team will escalate this to the Clinical Studies Oversight Group (CSOG) and the Sponsor of the study will be informed. Category 2: Any Other Studies NHSG and UoA highly recommend that evidence of attendance/certification at a recognised GCP training* course for non-ctimp research is available every 2 years. For both sponsored and hosted studies, staff working on the study must be named on a Delegation Log and documented evidence of GCP training, commensurate with the role they have in the study, is available. If a research activity is part of a person s normal clinical role and all other protocol activities are undertaken by a member of the research team, then no GCP training may be required, but this must confirmed with the Sponsor. Sponsorship a) For research sponsored or co-sponsored by NHSG and/or UoA, evidence of valid GCP training for the Chief Investigator and any local co-investigators is required and will be checked on receipt of application for sponsorship. If no valid evidence available, the CI/PI will be directed to the Training Team who will offer appropriate training courses. Page 5 of 6

6 6.5.2 b) Sponsorship of other studies (not CTIMP or High Risk) is not dependent on the CI/PI having valid evidence of GCP training. However, it is expected that the CI/PI will undertake GCP training within 6 months of receiving sponsorship. If not completed, sponsorship of current and future studies may be withdrawn or not given R&D Permission a) For research locally sponsored or hosted by NHSG, evidence of valid GCP training for the CI/PI is highly recommended and will be checked on receipt of application for R&D permission. If no valid evidence available, the CI/PI will be directed to the Training Team who will offer appropriate training courses. b) R&D permission for other studies (not CTIMP) is not dependent on the CI/PI having evidence of attendance/certification at a recognised GCP training course but is highly recommended. Training Records a) Certificates of evidence of GCP training for all researchers should be kept in the TMF/ISF of the study file and within staffs individual training records. (SOP-QA-2) b) Curriculum Vitae of researchers should detail attendance at a GCP course. *Please contact the Training Team in the R&D office to confirm recognised courses Page 6 of 6