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

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

3. 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

4. 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!

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

6. 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 –

7. Remote Site Initiation Objectives
21 CFR (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.

8. 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

9. 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.

10. 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.)

11. 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

12. 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.

13. 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.

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

15. 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

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

17. 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

18. 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.

19. 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.

20. 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

21. 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?

22. 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?

23. 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

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