WCTU Training Suite Site Set Up PDF

Welco me to SITE SET UP By Lucy Eggleston TOPICS Todays 01 WHAT IS SITE SET UP? TOPICS 02 SITE SELECTION 03 SITE SET UP 04 SITE INITIATION 05 DELEGATION LOGS 06 OFFI...

Welco me to SITE SET UP By Lucy Eggleston TOPICS Todays 01 WHAT IS SITE SET UP? TOPICS 02 SITE SELECTION 03 SITE SET UP 04 SITE INITIATION 05 DELEGATION LOGS 06 OFFICE TRIVIA Topic 1 WHAT IS SITE SET UP? What is SITE SET UP? A site within a clinical trial is a controlled environment where clinical research, development and testing can take place safely with appropriate oversight. In these settings, patients take part in supervised clinical trials and research activities. SOP 26 PAGE 3 Topic 2 SITE SELECTION CONTACTING INVESTIGATORS With previous experience CONFERENCES Site That your CI may attend PROFESSIONAL GROUPS SELECTION That may be relevant to your trial A feasibility questionnaire will be CLINICAL RESEARCH made by the CTU team and CI which is forwarded onto potential NETWORK recruiting sites. CRN’s across the UK may know of potential sites Potential Sites can be identified by PUBLICATIONS Related to your trial TOP TIP: It is important the feasibility forms are reviewed by the TMG for each potential site. Add to the decision/action log to confirm RECCOMENDATIONS BY acceptance or rejection of the potential site. COLLEAGUES Talk to your colleagues within the CTU! Topic 3 SITE SET UP Site SET UP All clinical research studies will gain ethical and site level approvals via the HRA approval system (See SOP 5-part 1 handling initial ethical approvals) Adding recruited sites once approvals are in place must be done using the IRAS amendment tool. Helpful SOPS: SOP26 SOP5 Topic 3 SITE SET UP Site Set Up HOSPITAL SITES LOCAL INFORMATION PACK A local information pack contains the organisation information document and the schedule of cost attribution template (SoECAT) and should be submitted via email to the following people once the sponsor has received the initial assessment letter of approval letter from HRA/HCRW: NHS R&D Offi ce LCRN Contact Local Research Staff PI OID Topic 3 SITE SET UP Site Set Up PARTICIPANT IDENTIFICATION CENTRES A participant identification centre (PIC) is an organisation, which could be either an NHS organisation, or GP practice that identify potential research participants for your trial. They have no other involvement in the research. PIC sites will still need an mNCA agreement however they do not require an SIV. It is recommended to set up an initial meeting to look at what is required. Topic 3 SITE SET UP 01 Completion of a model Non-Commercial Agreement (mNCA) 02 Site reviews the mNCA, localises the details and returns to the CTU 03 Site Set Localised mNCA reviewed by CTU and sent to Sponsor 04 Sponsor reviews and signs mNCA and returns to CTU Up PROGRESSION OF CONTRACTS WITH SITE 05 CTU sends signed agreement to site 06 Site representatives sign agreement and return to CTU 07 CTU convert final signed version to PDF and send a copy to site and Sponsor 08 CTU file a copy in the TMF Topic 4 SITE INITIATION Site INITIATION A site initiation visit, what we know as an SIV is set up between the central unit and potential participating site. A SIV Checklist (C05) is available to guide expected content of the initiation. Additional site initiation guidance (G14) is also available. Topic 4 SITE INITIATION Site Initiation Visit TOP TIPS FOR AN SIV SIV Slides – Set up for 1.5 hours Introductions Keep your slides engaging and concise. For help Introduce your team at the beginning and then ask for creating PowerPoints you can use Canva their Introductions. Write down names/job titles Contacts Take a break Ensure you record your R&D Contact and Lead Stop halfway through your slides and ask if anyone Research Nurse. Who wants to be on the mailing list? has any questions Splitting Slides Communicate How do they feel about opening the trial? Are all staff Changing the voice of the presenter can alert those supportive? watching. Split the slides with your CI to keep engagement Topic 5 DELEGATION LOGS Site LOGS Delegation Delegation logs record all study staff members’ significant study related duties. The PI will sign each staff member off. 25K+ You must have the delegation log signed before the site is given the greenlight. Each staff member will have specific roles which will be defined within the delegation log. (Template 22). You may need to amend these to ensure they are specific to your trial. Topic 5 DELEGATION LOGS Site LOGS Delegation Electronic delegation logs Quicker and easier than paper delegation logs! No need to print and scan! 25K+ Easy to update! Use Template 22/23 and personalise for your trial. 1 Save as PDF and open doc in Acrobat Reader. 2 Click the ‘Fill & Sign’ feature and add a text box with 3 details to form. Click the ‘Use a certificate’ feature to digitally sign. 4 Topic 5 DELEGATION LOGS Delegation TOP Log TIPS Use electronic logs if possible Send out infographic reminders to ensure staff member start and end dates are correct Ensure the PI has signed all staff member entries Ensure staff start date is not before the PI sign off date To open a site, you only need the PI’s signature, however, it is recommended to also have the lead research nurse before greenlight. Site Delegation Log Template: T22 Topic 6 OFFICE TRIVIA Office TRIVIA