Remote Site Initiation Visits Society for Clinical Trials Donna Brown May 15, 216

Introductions Let’s get to know one another Who are you? Affiliation Monitoring experience What you hope to gain from this workshop

Goal for Remote Site Initiation Visit Session To understand the remote process of preparing, collaborating with and verifying that a research site is adequately prepared to conduct a clinical research study To know how the Remote Initiation Visit fits into the site activation process

Workshop Objectives Understand objectives, requirements, process of a Remote Site Initiation Visit Review regulatory requirements Discuss remote visit planning and activities Participate in Remote Site Initiation Visit exercise Discuss findings and observations from the exercise Think and learn!

Remote Initiation Visit Who has been on a site initiation visit? Has anyone conducted remote site initiation visits?

Why conducte a remote visit? Contractual obligation Study design is low risk Experience with the site team Site staff are seasoned veterans Activities can be conducted remotely Budget ($$) Much of how we support our clinical trials activities is directed by our contractual obligations – sponsor or client may recognize that the need for on-site visits is not convincing Overall risk of the study is very low- Observational trial, data collection activity, etc –

Remote Site Initiation Objectives 21 CFR 312.50 (Sponsor responsibilities) Provide the investigative team with the information and tools to complete the trial successfully Clinical or Project Monitoring Plan, etc. Documentation of the remote visit objectives: Site staff training: Protocol, GCP, Monitoring Expectations, Specimen collection, processing, shipping, Data Collection and Submission, etc. Much assessing can be done by conference call, weekly checklist submission, Full study conference calls. Processes to discuss—screening, consenting, recruiting, drug accountability, site SOPs, home visits, maintaining contact for retention in the study, IRB requirements and guidance, OHRP prisoner certification, follow-up, etc.

Setting up the Remote Visit Determine processes for implementation Work flow and communications Confirm that key study staff are trained and understand study and regulatory responsibilities Create or use an established site readiness checklist Communicate timelines for expected completion of activities Collect checklists and review progress regularly Ensure targeted follow up with site staff on pending critical items

Remote Site Initiation Process: Planning Include all key stakeholders What critical items must be in place in order to schedule the visit? CTA executed PI has appropriate staff, documented on DoA Supplies on site (if appropriate) Key regulatory documents are filed in TMF Database availability (if appropriate) Study documentation is finalized (or near finalized): Manual of Procedures Specimen collection, processing and shipping manuals Project Team planning---When do initiation visit activities/planning begin? What requirements must the site meet before the initiation visit is scheduled? Use a checklist and if possible have site turn in on a regular basis to update on progress toward initiation visit. Confirming visit—memo confirming and agenda 1-2 weeks prior to visit—per EMMES or project requirements.

Remote Site Initiation Process: Planning Coordinate with site to prepare for the remote visit Communicate expectations and checklists (if used) Schedule the visit Confirm visit and distribute agenda Follow documented processes (CMP, SOPs, etc.)

Remote Site Initiation Process: Planning Adequate time IT and logistical planning Easy access to training materials Budget time for questions FAQs Obtain feedback on process Decide whether to record the session and provide disclosure on this process Central training vs personalized training Allow enough time up front to ensure technology requirements are adequate Ensure webinar software is downloaded and available on site in conference room or computers where site staff will participate Provide or post training slides for easy access

Remote Initiation Visit Activities Follow the general outline for on-site initiation activities: Protocol overview Site staff interviews and review of processes Facility tour Review regulatory documentation While we may develop the sides for the presentation and training, we frequently provide them to the PI to review and update and ask that the PI conduct the protocol training. This allows you to assess their understanding of the study and gauge involvement. When working with a site where you have existing knowledge, don’t assume the activities are being conducted in the same areas Let the team describe where and who is supporting the work. If devices are used, who has access, how are the accounted for, what communications will be had if issues arise with the device. Regulatory documentation review may be a summary of the materials that are still pending for study activation, process for ongoing review of the regulatory file, and common mistakes that are made in the regulatory documentation and submission process.

Initiation Visit: Review of Remote Site Visit Agenda In preparation for the remote visit, the webinar or teleconference is scheduled to ensure the key stakeholders can participate. This done once key activities, such are regulatory approvals, are in place and site staff are available to participate. If using a tiered initiation and activation process, such as initiation to proceed with screening, subsequent training may occur during a follow up remote teleconference or at an on-site visit.

Remote Initiation Visit Topics Investigator responsibilities Staff assignments Scientific misconduct reporting Quality enhancement processes Monitoring requirements Facilities tour

Roles and Responsibilities Investigator Oversight What are her/his expectations What are your expectations Staff Assignments Who Experiences Training Responsible for ensuring integrity and safety of the trial

Training and Assessment Quality enhancement processes Monitoring requirements Scientific misconduct reporting Communications Internal, external expectations

Remote Facilities Tour Staff offices Security Clinical facilities Private areas for consenting procedures Emergency preparedness Clinical and Research laboratories Distance from various areas Pharmacy Drug accountability process Storage Asking the leads supporting the clinical and research facilities as well as the pharmacy facilities to describe the protocol processes at their institution- again using open ended questions to gather the most information. Track from start to finish where all activities will be conducted Collect a site map Timing of activities

Remote Facilities Tour Satellite locations Documentation storage Equipment lists/inspection stickers/calibration records Adequate space for monitoring support Reference information from SS/SQV Asking the leads supporting the clinical and research facilities as well as the pharmacy facilities to describe the protocol processes at their institution- again using open ended questions to gather the most information. This is the time to determine potential problems or issues. Assess their knowledge of protocol procedures and assessment and scheduling. Keep your antenna up to pick up on things that don’t add up or make sense. Don’t be afraid to ask for further clarification of something.

Workshop Assignment Provided a summary table of several sites who have been selected to support a clinical trial All sites have met criteria for study participation, have a CTA executed and sponsor is anxious to start trial Given our discussions, let’s divide up into teams and decide who we will consider for a remote site initiation visit and who we recommend be assessed on-site. Feedback will be in 2 weeks after submission of summary.

Selection Criteria? Most Important Factor? Other Data You Would Request? Criteria Site A Site B Site C Experience 2 1 3 PI Experience SC Experience Score: 4 6 8

Site Rankings Which site is the best suited for a Remote Site Initiation Visit? Which site is best suited for an on-site Initiation Visit? What other information do you plan to collect?

Remote Initiation Visit Summary Summarize observations: What issues did you identify? What additional observations do you have from your interactions with site staff? What action items would you include in the summary discussion and the report?

Remote Initiation Visit – Follow-up Remote Initiation Follow-up: Site visit report/summary letter Follow-up memorandum to site Track action items and completion of them Activation Based on project and sponsor requirements No matter what the forum, always document the visit activities- who attended, what was discussed, any observations and action items A follow up document- summery letter, memo or full report should be provided to the site and filed in the TMF

Thank you for your participation! Remote Close Out Visit Thank you for your participation!