Study Resources

The transition of a clinical study from a written document into real-world medical research carried out by separate yet synchronized teams of Investigators and Coordinators across the country is an incredible feat. The training required for each clinical site is immense, as Investigators and Coordinators learn the novel technology as well as the specifics of screening, enrollment, and data management. To effectively implement a clinical study, sponsor companies should provide Investigators and Coordinators with study aids and tools as supplementary resources to the protocol.

Would you agree that most clinical trial protocols are organized for compliance with FDA guidelines rather than for user-friendliness and ease of executability by the clinical sites? Additional study aids can help the investigators, O.R. staff, and coordinators properly utilize an investigational device, follow detailed procedural steps, and understand data collection requirements that may not be spelled out in the protocol. This will, in turn, help sites maximize enrollment, minimize protocol deviations, and capture high-quality data.

Simply put: make sites feel supported in your study (rather than burdened) and they will be more engaged and motivated to support your study. Sponsor companies that proactively create suitable training documents, study guides, video clips, and checklists for their sites save time and money throughout the trial. Think about your protocol from the perspective of the site staff seeing it for the first time: what additional documents would be helpful to them when learning its implementation? Listed below are additional resources to consider providing for Investigators and Coordinators.

Additional Resources for Investigators:

1. Anatomical Model & Demo Product

Bring an anatomical model to the SIV for a hands-on demo of the product. Be sure to cover specific intraoperative details and let the surgeon practice. Provide investigators with a nonfunctional demo product to show to patients during screening visits, this will assist with enrollment.

2. Investigator Flow Chart

Provide a brief flow chart for the investigators outlining their main responsibilities during the trial. Be upfront about expectations during the SIV, as this is the first step in developing a working relationship.

3. Investigator Surgical Technique Guide

A highly visual document filled with tips for surgical techniques, product preparation, product deployment, and intraoperative communication.

4. Patient Brochure

Always have a patient brochure that explains the purpose of the study in straightforward terms to the patient; this helps with enrollment. Along these lines, always have the Investigator introduce the study to the patient, as they have the relationship with the patient.

5. Pre-Case Walk Through

A short powerpoint presentation, poster, demonstration video, or audio clip is useful to review with surgeons or study teams prior to study procedures when there is complex product preparation, deployment, or intraoperative communication required

6. Intraoperative Training Tools

Think about the questions Investigators or O.R. staff may ask during surgeries and be prepared with a laminated poster or visual demonstration.

Additional Resources for Coordinators:

1. Coordinator Study Guide

The Coordinator Study Guide is a simple and user-friendly document that outlines everything that the Coordinator needs to do for each study visit, including all procedural steps and data collection requirements. When designing the study guide, envision the coordinator reading your Protocol and wondering: “how do I get started, what specific data do I need to collect, which system(s) do I need to access for various study tasks...?” Anticipate what may be difficult and provide proactive documents to help them. The Study Guide should list what should be done, what supplies are needed, what tests will occur, what forms need to be filled out for each study visit, etc. We strongly suggest printing this as a laminated spiral-bound booklet, with tabs indicating each study visit.

2. Sponsor Company Communication List

Establish clear pathways for communication between site and sponsor company at the SIV. Will the FCE be the main contact for the Coordinator’s needs? Otherwise, provide a list of specific people that they should contact for specific types of questions.

3. Pocket Card for Inclusion/Exclusion Criteria

An easy-to-read laminated card listing the inclusion/exclusion criteria for your study. Simplify the coordinators screening efforts as much as possible.

4. Screening Guide

A brief screening guide that explains the screening process, screening timeline, and the steps for completing the screening log. This could be included in the Coordinator Study Guide.

5. Coordinator ‘Day of Surgery’ Checklist

What does the coordinator need to bring with them on the day of surgery? What steps does the coordinator need to do before, during, and after the surgery? Include a checklist with the additional items the OR staff will need to have on-hand as well (and ask the Coordinator to confirm that they do). This is another document that could be included in the Coordinator Study Guide.

6. Case Report Forms

Case report forms should be concise, flow appropriately both for capturing data and later entering it into the electronic data capture (EDC) system, and be simple to use.

7. Study Visit Scheduling Tool

A document or Excel sheet to visualize the study schedule and determine the visit windows for individual subjects. Sometimes the electronic data capture (EDC) will have a tool built-in for determining the visit windows.

At FCE Source, we have decades of collective experience designing documents and study aids to help Investigators and Coordinators successfully complete medical device clinical trials. Contact us at info@fcesource.com and we’d be happy to discuss how we can help make your study a success.