Date: 23 rd December 2014 Version 5 Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03)

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1 Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03) Approvals Principal Author Name: D. Skelhorn Signature: D. Skelhorn Date: 22/12/2014 Quality Assurance Officer Name: p.p. J Ryan Signature: J. Ryan Date: 08/01/2015 NWORTH Director Name: R.T. Woods Signature: R.T. Woods Date: 18/02/2015 Disclaimer: Printed SOP's are considered uncontrolled. To ensure you are working with current version always refer to the pdf version on the NWORTH website. North Wales Organisation for Randomised Trials in Health (& Social Care) (NWORTH) Institute of Medical & Social Care Research (IMSCaR) Y Wern, Holyhead Road, Bangor University, Bangor, Gwynedd, LL57 2PZ Telephone: nworth@bangor.ac.uk

2 SOP number: NWORTH 3.03 Page 2 of 8 DOCUMENT HISTORY Version number Effective date Authorship 1 11/02/07 Compiled Ceri Bray Angela Gliddon 2 16/04/08 Angela Gliddon Ceri Bray 3 19/07/10 Debbie Skelhorn Angela Gliddon 4 12/12/12 Debbie Skelhorn Michelle Williams Summary of changes New Updates SOP number changed from 9 to Layout revised, SOP references updated, sections on site selection and activation added. MOP changed to trial specific procedure, additional clarification added to section 5.4, references section 9 updated 5 18/02/15 Debbie Skelhorn Minor. References updated, MOPs removed from text 1. Table of Contents 1. Table of Contents Purpose Responsibilities Procedure Procedure Flow Chart Overview Site selection Site set-up visit and training Study Documentation Site activation Training plan for SOP implementation Glossary of Terms References Referenced SOPs Appendices... 7 Appendix 1 Trial initiation and site set up checklist... 8

3 SOP number: NWORTH 3.03 Page 3 of 8 2. Purpose To describe the process of site initiation and set up 3. Scope This procedure applies to trials for which NWORTH has overall responsibility. It covers the requirements for CTIMP s. For non- drugs trials relevant aspects of this SOP should be applied. 4. Responsibilities The Chief Investigator is responsible for ensuring that ethics, R&D, and MHRA (if required) approval are in place prior to recruiting participants. The Principal Investigator (for multi-centred studies) at each site is responsible for ensuring that Site Specific Assessment (SSA), where required, and local NHS R&D approval are in place for their site prior to recruiting participants. The Director of NWORTH has overall responsibility for the integrity of trials managed by NWORTH. The Trial Unit Manager is responsible for ensuring trial Centre/Site set-up is in keeping with the principles of GCP this achieved through periodic meetings with trial managers. Trial Managers/Co-ordinators (for their specific trials) are responsible for: ensuring that regulatory and ethics approval for a Centre/Site is obtained before a site visit and training takes place arranging a visit date when the PI is able to attend ensuring each site has sufficient copies of the study documentation for inclusion in the Investigator Site File (ISF) ensuring all site team members have complete understanding of the trial and it s procedures ensuring all site team members have an understanding of the principles of GCP obtaining signatures; PI s to trial protocol, all signatures on a training form (delegation log) and SOPs or trial specific procedures obtaining information that is particular to that site and may affect the running of the trial on that site. Trial data manager and IT Specialist are responsible for: ensuring training for all aspects of randomisation, data collection and input of electronic data (ref. SOP 5.01 randomisation, 6.01 data management).

4 SOP number: NWORTH 3.03 Page 4 of 8 5. Procedure 5.1 Procedure Flow Chart Ethics approval, sponsorship, funding, research governance approvals are agreed for the trial as a whole. Site-specific ethics and regulatory approvals are obtained and copies filed in NWORTH TMF and site ISF A date for a site initiation visit is arranged At Site set-up visit Discuss clinical aspects with PI, obtain his/her signature on the protocol. Train local co-ordinators on data collection and entry Train any other staff involved in trial-specific procedures or documentation Log all training and obtain signatures of trainer and trainees Train pharmacy staff (for CTIMP s) Trial manager/coordinator records any site-specific issues likely to affect the trial and takes action to resolve any issues to be agreed; with a timeline for completion Initiation visit report compiled, including any agreed actions, answers to any questions raised. Copy filed in TMF and copy sent to the PI for filing in ISF, copy to CI Confirmation that all agreed actions have been satisfactorily addressed and report filed 5.2 Overview After regulatory and ethics approval and before a site opens participant recruitment, the Trial Manager will organise a site visit to inform and train all site staff involved in the trial, to ensure that they have a thorough understanding of the trial procedures. The Trial Manager will develop a thorough understanding of each specific site s local practice including patient pathways.

5 SOP number: NWORTH 3.03 Page 5 of Site selection When selecting study sites consideration should be given to the availability of a suitable PI, the sites viability in terms of their ability to recruit adequate numbers, what experience they have running the specific type of trial, is there any potential conflict of interest with other studies they are running, do they have a proven track record, do they have the relevant resources to support the trial, will they be able to be ready for start-up in the required time frame. 5.4 Site set-up visit and training The Trial Manager will organise the site visit part of which should include relevant training on conducting the trial to ensure compliance with the principles of GCP and the requirements of the study protocol. This should include all site team members where possible: Principal Investigator Co Investigators Local Coordinators others relevant to the success of recruitment e.g. surgeons, pharmacists, laboratory staff, data managers, line managers Note: training will be an ongoing process, therefore at the site set up visit it may be necessary to conduct the training for those team members who are needed for trial start up. A programme of training should be agreed to ensure that all staff have the relevant training before they participate in the trial. Relevant team members from NWORTH may be required to attend e.g.: Data Manager IT Specialist Areas of training to be covered during the visit Aims of trial Trial procedures Delegation log Primary and secondary endpoints Inclusion/exclusion criteria Data training, including CRFs or electronic data capture Inform monitoring visits will take place Trial specific SOP s Adverse Events Trial-specific lab procedures If a drug trial, discuss with PI and pharmacist the prescription of IMP, storage, and labelling of the medication and documentation of received, prescribed and destroyed IMP see SOP 4.03 Safety monitoring including pharmacovigilance and 3.08 trial supplies and labelling. Note: Training can also be organised at a central site. During the visit check that trial staff have up to date GCP training, if not; ensure it is scheduled and completed prior to participant recruitment, and if labs are being used check equipment is appropriate freezer temperatures, centrifuge speeds, calibrations etc. Establish what site systems are in place for temperature monitoring and control.

6 SOP number: NWORTH 3.03 Page 6 of Study Documentation The Trial Master File and the Investigator Site File (ISF) must be established before recruitment of participants begins; the list of essential documents for TMF and ISF is detailed in SOP 3.04 Trial Master File and the Investigator Site File It is the investigators responsibility to ensure that all the relevant trial documents are filed in the ISF, this should be checked during the set up visit. All documentation to be version controlled and dated. All site team members should have access to the relevant trial procedures. 5.7 Site activation It is only when all relevant trial specific training and any agreed actions have been completed that the site can become active in the study. Trial activation will be minuted at the trial management meetings. 6. Training plan for SOP implementation Training on this SOP will be carried out in accordance with NWORTH training SOP Glossary of Terms CI Chief Investigator The investigator with overall responsibility for the research. In a multi-site study, the CI has co-ordinating responsibility for research at all sites. All applications for ethical review should be submitted by the CI CRF Case Report Form A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. CTIMP Clinical Trial of an Investigational Medicinal Product Any investigation in human subjects, other than a non-interventional trial, intended: a. To discover or verify the clinical, pharmacodynamic effects of one or more medicinal products; b. To identify any adverse reactions to one or more such products; c. To study absorption, distribution, metabolism and excretion of one or more such products with object of ascertaining the safety or efficacy of those products. GCP Good Clinical Practice ISF Investigator Site File The file in which trial documents are kept in each site in accordance with ICH GCP Trial specific procedure(s) written instructions and /or records developed for and adopted as standard practice in a specific trial. PI Principal Investigator The investigator responsible for the research site where the study involves specific procedures requiring site-specific assessment. There should be one PI for each research site. In the case of a single-site study, the CI and PI will normally be the same person.

7 SOP number: NWORTH 3.03 Page 7 of 8 SOP Standard Operating Procedure The written instructions and records of procedures agreed and adopted as standard practice. SSA Site-Specific Assessment An assessment of the suitability of the investigator, site and facilities made for any study with a Principle Investigator at each research site. The application for SSA should be made by the Principle Investigator using the Site-Specific Information (SSI) Form, which can be found on the IRAS website. In the case of a multi-site study, the outcome of the SSA should be notified to the main REC within 25 days. Trial Site A hospital, local government office, GP surgery etc with approval to participate in a trial. The site from which local trial activities are co-ordinated. TMF ( Trial Master File 8. References ICH topic E6(R1) guideline for GCP line/2009/09/wc sjsp Health Research Authority, Site Specific Assessments MRC GCP guidelines for other trials 9. Referenced SOPs NWORTH Training SOP 2.01 NWORTH Trial master file and investigator site file SOP3.04 NWORTH Trial supplies and labelling SOP 3.08 NWORTH Safety monitoring including pharmacovigilance SOP 4.03 NWORTH Randomisation SOP5.01 NWORTH Data Management SOP Appendices Appendix 1 Trial initiation and site set up checklist

8 SOP number: NWORTH 3.03 Page 8 of 8 Appendix 1 Trial initiation and site set up checklist Checks Comments 1. Confirm all approvals are in place: Ethics Research governance ( R&D) Sponsorship Funding MHRA ( if applicable) 2. Confirm TMF and ISF(s) are established 3. Site set up visit dates: 4. Confirm the following training requirements have been delivered to the relevant trial staff ( note if any are not applicable, add any additional requirements) Aims of trial Trial procedures Delegation log Primary and secondary endpoints Inclusion/exclusion criteria Data training, including CRFs or electronic data capture Inform monitoring visits will take place Trial specific SOP s Adverse Events Trial-specific lab procedures if applicable If a drug trial, procedures for labelling, receipt, storage, prescription, recall, destruction, of the IMP 5. Confirm training log has been updated 6. Confirm site visit report has been written, circulated and a copy filed in the TMF 7. Confirmation that all agreed actions have been satisfactorily addressed 8. Site activation Note: This is not an exhaustive checklist it may be tailored to meet specific trial requirements.