Pre-screening potential patients for a clinical study is common practice at most research sites. It can save time by quickly identifying subjects who may qualify for a study, prior to having them move on to the informed consent process. Pre-screens can be done in person, over the phone, or in some cases, even online. The role technology can play in this process is important not to overlook. Regardless of the collection method, the questions and any accompanying script must first be reviewed by the IRB to ensure the materials presented are not beyond the scope of the inclusion/exclusion criteria.
When time is a precious commodity at a research site, it can be advantageous to delegate the pre-screening process to a non-clinical team member. Since the pre-screen itself cannot include any research procedures, it’s quite practical for anyone at the research site to conduct the pre-screen. It is important, however, to ensure the script used is well written and followed as closely as possible. A good script should:
- Identify the staff member conducting the research and inform the subject of the type of the questions that will be asked – that they are to determine eligibility only, and that some may be sensitive in nature. If the staff member is not on the clinical team, it is best to disclose this so as not to give the subject the false impression they are speaking with a medical professional directly related to the study.
- Tell the patient how long the call is expected to take, and offer the option of completing the pre-screen in person or at another time that might be more convenient.
- Let the subject know they can stop the interview at any time if they don’t feel comfortable continuing.
- When possible, a closing statement should inform the subject of what the next steps will include with a timeline. It should also indicate what will be done with the information collected (destroyed or stored, and for how long and where).
- Concisely disclose applicable information to minimize future dropout rates.
As pre-screen questionnaires are completed, either manually or electronically, it is equally important to have an action plan to ensure eligible subjects don’t slip through the cracks and the information from those who didn’t meet the criteria are handled appropriately. Who will follow up with those who are eligible and when? Who will be responsible for managing the information collected? If the initial collection was done on paper, consider the advantages that maintaining this information electronically could provide:
- Easy retrieval of the information when you need it.
- Quick updates to answers or ability to complete unanswered questions at a later time.
- Analyze ineligible forms to modify questions if enrollment has slowed to a stop.
- If storing for a period of time, eliminate excess paper around the clinic.
- If using a clinical trial management system, easily transition the subject from pre-screen to enrolled.
Pre-screening is a common strategy to add to any patient recruitment campaign. To maximize your pre-screen activities, make sure you have a well-written script, ask the right questions, and have a follow up plan in place. Additionally, the use of technology to help manage your pre-screen paperwork can serve many purposes. With a good plan and the right technology, sites can streamline the pre-screen process and ensure they are identifying the right candidates for their study.