Joint R&D Support Office SOP S-2011 UHL

Transcription

1 UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES Joint R&D Support Office SOP S-2011 UHL Site Initiation for Clinical Trials of Investigational Medicinal Products research Sponsored by the University Hospitals of Leicester NHS Trust PCG Registration C17/2013 OFFICE BASE Joint Research and Development Support Office Research & Development Leicester General Hospital Gwendolen Road Leicester LE5 4PW

2 Standard Operating Procedure: SOP S-2011 UHL Site Initiation for Clinical Trials of Investigational Medicinal Products research Sponsored by the University Hospitals of Leicester NHS Trust Research & Development April Introduction This Standard Operating Procedure (SOP) describes the procedures for initiation for all Clinical Trials of Investigational Medicinal Product (CTIMP) research sponsored by The University Hospitals of Leicester NHS Trust (UHL) that are either single or multisite investigator led trials. An initiation visit will be performed prior to the first patient being recruited into that study 2. Scope To ensure that all required trial authorisations and documentation are in place and that the protocol and trial procedures are reviewed with the Investigator and the trial staff in accordance with the protocol, SOPs, GCP, and the applicable legislation. Initiation is integral to the quality control of a clinical trial and is designed to ensure quality of the trial according to Sponsor requirements 3. Procedure The Initiation visit will be performed as soon as all required approvals, documentation and procedural information are in place at the study site. The Chief & Principal Investigator(s), all research staff working on the study and staff from departments that will be involved in the study, will be invited to participate in the initiation visit, and be available during the visit where appropriate. Where necessary a separate visit may need to be made to ancillary departments i.e. pharmacy. Preparing for the Initiation Visit The monitor must ensure that all approvals and regulatory documentation are in place to open the study at site. This includes a favourable site specific assessment, and agreement that staff capacity is available to run the study at site. The trials monitor or designee will outline the requirements for the Site Initiation Visit, in terms of attendance requirement for the study team and in terms of time and resources. During the Site Initiation visit The monitor will: Discuss the intended recruitment methods for the trial. The current versions of the PIS/ICF will be reviewed and the monitor will discuss GCP compliant informed consent procedures with the Investigator and relevant personnel. Ensure that the CI/PI has completed the delegation of authority log and will verify that all duties delegated by the PI/CI to other site staff have been documented on the delegation of authority log. This is an on-going process completed throughout the trial. Verify that a signed and dated Curriculum Vitae has been provided by the Chief / Principal Investigator. In addition signed and dated Curriculum Vitae have been filed for other site staff listed on the delegation of authority Log. SOP S-2011 UHL Site Initiation for Clinical Trials of Investigational Medicinal Products research Sponsored by the University Hospitals of Leicester NHS Trust Page 2 of 5

3 Verify that all identified trial staff have been appropriately trained in both GCP and the trial protocol. All trial staff attending the Initiation visit will sign the site Initiation visit attendance log. Review with Investigator and relevant staff their understanding of the protocol, study procedures, investigational product, randomization procedures, unblinding procedures and timelines. Ensure that the Investigator has defined what will be considered as source data and that this has been accurately documented. In addition the monitor will discuss the Investigators responsibility to provide access to source data for monitoring and audit purposes. Clarify who will be responsible for CRF completion and clarify the procedure for entering data, as well as changes and corrections. Review the safety profile, Investigator Brochure (IB) or Summary of Product Characteristics (SmPC) for the Investigational Medicinal Products (IMP) and verify that the most current documentation is filed and signed and dated. Review all IMP procedures including but not limited to receipt, storage, dispensing, accountability, return and destruction. Check the storage conditions for the IMP even if it has not been received at site at the time of the visit. Review with Investigator and relevant staff their understanding of the protocol, study procedures, investigational product, randomization procedures, unblinding procedures and timelines Check that laboratory facilities and arrangements for the dispatch of samples to the laboratory are organised and that any specialised equipment that may be required, will be available throughout the period of the trial, e.g. centrifuge, freezer, etc. Documentation relating to pathology processes and supplies should be stored in the Laboratory Manual. Ensure that procedures for allocation of participant numbers has been reviewed. Ensure that the site has all staff, facilities and equipment to perform the study. Verify that staff understand the requirements for safety reporting as per SOP C-2002 UHL. Ensure that the Investigator has a procedure in place for the emergency unbinding for the study. Ensure that the Investigator is aware of their responsibility to communicate with the Ethics Committee and R&D department and relevant Authorities on an on-going basis. Check that the site has all staff, facilities and equipment to perform the trial according to the study protocol and that all protocol specific procedures (including handling of any samples) have been explained. Ensure that the Investigator is aware of their responsibility for the on-going maintenance of trial documentation including correspondence in the Trial Master File as per SOP-2007 UHL Ensure that the Investigator is aware of their responsibility to ensure adequate cover during absences and of their obligation to have on-going oversight of the trial. SOP S-2011 UHL Site Initiation for Clinical Trials of Investigational Medicinal Products research Sponsored by the University Hospitals of Leicester NHS Trust Page 3 of 5

4 Following the Initiation Visit The monitor will promptly submit a written report within 21 days of the visit, recording any items outstanding or clarification required. The Investigator will be asked to review the report promptly and supply responses with regards to any issues that were highlighted at the initiation visit. The report will be signed by the monitor and the Investigator and the original will then be filed in the Trial Master File. The trial should not be commenced at the site until the sponsor is satisfied that all issues raised at the Initiation visit have been resolved. The monitor will establish the next monitoring visit date and requirements with the Investigator. Monitoring is undertaken as per SOP S-1007 UHL Site management (Monitoring). 4. Responsibilities Responsibility Undertaken by Activity 1. Monitor Monitor To ensure that all approvals and regulatory documents necessary for the trial to commence at site are in place prior to the initiation visit occurring. 2. Monitor Monitor To ensure that all appropriate staff who will be involved in the trial at site are invited to attend the initiation visit. 3. Monitor Monitor To ensure all areas of the trials as detailed in Section 3 During the site initiation visit above, are discussed with the Principal Investigator/Research team so that everyone is aware of their individual and collective responsibilities within the trial. 4. Monitor Monitor To ensure that all staff involved in the trial have the necessary training/qualifications in place as detailed in Section 3 during the site initiation visit above. 5. Monitor Monitor Submit a detailed written report within 21 days of the visit recording outstanding items and any clarification required. 6. Monitor Monitor Review the Investigator s responses to the written report and ensure the report is signed by the Monitor and Investigator and that the original is filed in the Trial Master File. 7. Sponsor Sponsor Ensure all issues raised at the initiation visit have been resolved prior to trial commencement at site. 5. 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. SOP S-2011 UHL Site Initiation for Clinical Trials of Investigational Medicinal Products research Sponsored by the University Hospitals of Leicester NHS Trust Page 4 of 5

5 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 S-2011 UHL Site Initiation for Clinical Trials of Investigational Medicinal Products research Sponsored by the University Hospitals of Leicester NHS Trust Page 5 of 5