Summary
Highlights
The speaker introduces the topic of clinical research screening visits, emphasizing their importance. He highlights that a successful screening visit begins with effective pre-screening, ensuring that interested individuals also qualify for the study based on their medical records. Obtaining medical records beforehand is crucial for a decent pre-screening process.
Thorough preparation is essential for a successful screening visit. This includes preparing all necessary documentation the day before, such as the latest consent forms. The speaker suggests conducting mock visits to walk through the steps, including informed consent and electronic patient-reported outcomes. Being unprepared can lead to an unprofessional appearance and inconvenience to the patient.
On the day of the visit, a crucial step is to text or call the patient an hour before their appointment to provide instructions on how to reach you upon arrival. This prevents confusion, especially if the office is closed or intimidating. Once the patient arrives, avoid long waits; bring them to a private room immediately, offer refreshments if not fasting, and make them comfortable.
The informed consent process must be conducted in a private room, ideally with a clinician, PI, or sub-investigator present. Ensure the latest approved consent form is used. Patients should be given ample time to ask questions, and the site must confirm their understanding of all risks, benefits, potential side effects, study visits, payments, and the right to withdraw. Emphasize that the consent form is not a contract, and document the entire process.
After informed consent, follow the protocol for the order of assessments. If no specific order is given, use common sense; for example, address fasting requirements or anxious patients by prioritizing blood draws. Meticulously follow the lab manual for drawing, packaging, and shipping samples, as procedures vary by study. Ensure EKGs are performed correctly, read by a central reader or clinician, and signed on the day of the visit, and document urine drug screens if required.
Gather comprehensive medical history and concomitant medications directly from the patient, not just their records. Document the indication, start/stop dates, and ongoing status for each medication. Critically, compare every medication and medical condition against the study's inclusion and exclusion criteria, paying close attention to prohibited medications and washout periods. For female subjects of childbearing potential, explain contraception requirements.
After the patient leaves, ensure labs are shipped on time, mindful of cutoff times, to avoid redraws. Expect lab results and EKG readings within a few business days. The PI must sign off on clinical significance for all lab results, noting any abnormalities and discussing them with the medical monitor if necessary. Officially screen the patient into the IRT system on the same day. Finally, complete all required logs, including the screening and enrollment log, informed consent log, and master subject identification log, and obtain additional medical history if needed.