Explaining the Importance of Feasibility Questionnaires and Site Selection Visits
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The document emphasizes the significance of feasibility questionnaires and site selection visits in clinical trials, explaining that these tools influence a sponsor's decision when awarding studies to research sites. It details common questions found in feasibility questionnaires and underscores the importance of providing realistic and conservative answers to avoid underperforming expectations. Moreover, it highlights the role of site selection visits in validating questionnaire responses, which can impact a site's selection for a study.
Explaining the Importance of Feasibility Questionnaires and Site Selection Visits
- 1. 1 Explaining the Importance of Feasibility Questionnaires and Site Selection Visits
- 2. 2 No matter if you’re reading this because you aspire to become a CRA, or you’re a study coordinator, or maybe you’re part of a research site, learning about feasibility surveys and questionnaires is important for everyone that’s in any way involved in clinical trials. In this article, we’ll try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsor’s decision of awarding you the study. Explaining the Importance of Feasibility Questionnaires and Site Selection Visits
- 3. 3 Explaining the Feasibility Questionnaire 3.2M When clinical research sites look for potential studies, they usually email or fax the study manager or sponsor with their pitch (presentation of the site and their interest in the study). If they’re interested in your site as a potential partner, they will usually first send you a CDA (confidential disclosure agreement) which you have to sign.
- 4. 4 After you’ve done this, they will normally send you a protocol synopsis as well as a feasibility questionnaire. This document usually varies in form and length, although most of them would be approximately 8 to 10 pages long. Explaining the Feasibility Questionnaire
- 5. 5 Most Common Questions in a Feasibility Questionnaire ● How many patients can your site enroll for the study? ● How many patients can your PI see on a monthly basis? ● How many subjects can your site screen on a monthly basis? ● How many subjects can you randomize per month? ● Information about the site investigators ● Staff information ● How many years of experience has your main coordinator? ● Number of clinical trial coordinators employed at the site
- 6. 6 How many clinical trials are given to one coordinator? (in order to check if your site coordinators are overworked) Do you have staff available during holidays? What sources would you use to recruit your study participants? (the best answers would be from your own PI’s private practice or physician referrals) How many clinical trials have you conducted in the past in the same therapeutic area? (in order to assess the site’s expertise) Most Common Questions in a Feasibility Questionnaire Do you have staff that the patients can reach 24/7 by phone? Have you worked with this sponsor or CRO in the past? Therapeutic specialty areas of the site PI (to see if the PI fits the study that you’re applying for) What types of advertisements do you use and how well do they work?
- 7. 7 Most Common Questions in a Feasibility Questionnaire Electronic medical records or paper-based records? Have you used EDC platforms and which ones? Do you have a CLIA certificate? How many clinical trials do you have that are currently ongoing? (in order to find out if your staff, PI, and coordinator are overworked and how much attention will you be able to dedicate to their study) The number of clinical trials your site has conducted in the last 5 years Do you have any ongoing competing studies? Do you have a secure subject record storage? Do you own a double-locked drug room that’s temperature- controlled? Has your site been inspected by the FDA, or have you ever received a warning letter from the FDA?
- 8. 8 The answers that you as a site, in this case, give to these questions should be as close and as realistic as possible. At the end of the trial, sponsors will look at your performance, and they will see if you were able to reach the numbers that you gave as an answer in the feasibility questionnaire.
- 9. 9 The best thing you can do when answering these questions is to be conservative! It’s much better if you gave a number of 5 enrolled patients and in the end you enroll 10 - which means you exceeded their expectations - than to plan to enroll 20 patients but then manage to enroll only 10. Being conservative and then exceeding the expectations will make you - as a site - look better and more professional in the eyes of the sponsors. The worst thing you can do is over exaggerate with the answers!
- 10. 10 The Importance of Site Selection Visits The feasibility questionnaire that you give to sponsors will also be double-checked when they come for the site selection visit. Usually, a CRA will come to see your site and double-check the answers that you previously gave in the questionnaire.
- 11. 11 After the CRA checks if all the answers fit and are correct, the sponsor will either select your site and give you the study or he won’t. To ensure that there aren’t any problems during the site selection visit and that you increase your chances of being selected, always give the most appropriate and balanced answers in the feasibility questionnaire. The Importance of Site Selection Visits
- 12. 12 Once you have reached the point of having a site selection visit, usually the chances are pretty big that the sponsor already wants to give you the study. However, if you make some big mistakes during this visit you might change his/her mind. The Importance of Site Selection Visits