Setting Your Clinical Trial Site Apart from Other Sites During Pre-Study Visits

by | Dec 20, 2021 | Uncategorized | 0 comments

Study sites want to be selected for clinical trials – especially when it’s a study that the site knows it is equipped to carry out and deliver high quality results. Since many different potential study sites submit applications, clinical trial site selection can be competitive.

Knowing the details of site selection from the beginning of the process to the end will help sites do the important legwork that will set their site apart from other applicants.


The Importance of a Clinical Trial Site’s Preselection

Clinical trials begin long before the trial itself actually starts. A trial truly originates when an upcoming study is posted and Investigator Interest Questionnaires are available.

Study invites can be automatically generated and/or sites or investigators can receive referrals from Clinical Research Associates (CRAs) based on personal past experience. The investigator submits an application or inputs their information into a database that is used by the Sponsor or CRO to narrow down the list of potential sites.

Investigators should take time completing the application or information requested. Questions should be answered thoroughly and truthfully. Detailed, thoughtful responses show that the investigator and site are taking the application process seriously – and can be trusted to continue these professional efforts throughout the trial.

As the liaison between the Sponsor or CRO and the study site, CRAs are involved with clinical trials from the beginning to the end. Site selection is a very important part of the CRAs role. Choosing the best site can be a major factor in the success – or the challenges – of a trial.

Investigators who develop and maintain relationships with CRAs – and who make the CRA feel confident in their site selection decision – will be most successful.

When a site has been preselected, the investigator will receive a confidentiality disclosure agreement (CDA) to allow additional information to be released to the site.

The next step for site applicants is to complete a feasibility survey or questionnaire to help the Sponsor or CRO verify if the site has the required resources and capabilities.

Each step should be completed on time and – with all requested information.

Goals for Study Sites at Site Selection Visits

CRAs conduct site selection visits (also called a pre-selection visit (PSV) or a site qualification visit (SQV)) with each finalist. During these visits, the CRA meets with the investigator and study coordinator, tours the site, makes observations, and examines equipment.

The CRAs goal is to determine if the site is a feasible location for the study and if it will be able to meet the study goals and protocols.

The site’s goal is to instill the CRA with confidence that the site is equipped to successfully and effectively carry out the trial protocols. The CRA and the investigator meet to further evaluate interest in the trial.

Most importantly, all parties need to be fully transparent about the site’s capabilities. Over or understating a site’s capacity can lead to the wrong site selection and/or determining too late that the site is actually not suitable for carrying out the study protocol.

Following the visit, the CRA gives a report to the Sponsor or CRO that details findings, updates the feasibility survey, and provides an educated recommendation.

Read more about site selection visits in this article from Dan Sfera or this article from MHA Online.

3 Steps for a Successful Site Visit

Since CRAs visit multiple potential sites for a clinical trial, it is advantageous for the investigator and site to be prepared and organized for their site selection visit.

These 3 steps will help trial sites set themselves apart at site selection visits.

1. Plan the visit to the clinical trial site

Taking the time to think about and plan an agenda for the site visit will lead to a more efficient, and likely more successful, visit. 

Make sure to schedule time for meetings with specific people, tours, and anything else the CRA may want or need to see in order to make an informed decision.

If the CRA has certain expectations for the visit, make sure they are met – and exceeded! 

2. Creating a file and keeping copies of important documents

Key documents are an important part of each clinical trial – and will be discussed at all pre-study visits. 

Putting all of the documents in a file will ensure that they are easily accessible during a visit. Take it a step further and make hard copies for anyone who will be involved with the visit.

A complete checklist of important documents is available in the free download!

3. Preparing to discuss pertinent study information

Preparation is imperative to the success of the site visit. Be ready to discuss everything that you have on the agenda and all aspects of the study. Your knowledge will show the CRA that you are taking the study seriously.

If a topic comes up that you were not prepared to discuss, say that you will look into it and will follow up with the CRA – and make sure that you do!

A list of study information that you should be prepared to discuss can be found in the free download.

Following these steps or customizing them for a specific study will result in a professional and efficient site visit that will help set your site apart. 

Read more about site visits in this article from The Ohio State University Center for Clinical and Translational Science.

Why Sites Should Follow Up After a Site Selection Visit

If your clinical trial site is selected (congratulations!), you’ll want to request a written notification. You can also start processing protocol documents including a budget, contract, and regulatory documents.

If your site is not selected, following up with the CRA to help understand the reasoning could help with future site selection visits. This part is also a good way to show the CRA that your site may not have been the best for this particular study, but is a site to keep in mind for future studies.

Undoubtedly, the site selection visit is extremely important! Sites that make it to this final stage of the selection process want to definitively be the most prepared and qualified to host the study. 

According to Dan Sfera, sites should always try to give CRAs a positive experience with work ethic, professionalism, enrollment capabilities, etc. so that the CRA refers the site for future clinical trials.

Read more about site selection visits in this article from GuideStar Research.

Grab the information in this article and use it as a super-handy checklist to make your next site selection visit a success!

If you are a clinical research professional with something that makes a site stand out during site selection visits (good or bad), please comment below! 

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