If you’re interested in clinical research, you’ll probably be responsible for facilitating a clinical trial throughout your career. Clinical trials are research studies conducted with people. They are used by researchers as a means of determining the effectiveness of a new drug, medical device, or another form of treatment for public use. Clinical trials are vital in the field of medical research, as they are the primary method of obtaining useful information about how a treatment behaves in humans.
As a clinical researcher conducting clinical trials, one of the processes you may be responsible for organizing is subject screening. Subject screening is a step involved in every clinical trial in which subjects are evaluated to determine whether they qualify for participation in the trial. Below, discover why subject screening is important in ensuring an accurate clinical trial, and how the process works.
Why Subject Screening is Important After Getting Your Clinical Research Diploma
Once you’ve completed your clinical research training, it’s important to conduct subject screening to enhance the safety of the clinical trial. As part of the screening process, eligibility requirements are used to ensure that each participant can safely participate in the trial. These eligibility requirements are designed to avoid potential health or safety risks for participants. In order to participate, individuals must meet each of the inclusion criteria, and none of the exclusion criteria.
Those with a clinical research diploma should know that subject screening enhances the safety of participants
Common inclusion criteria include:
- Age range e.g. 18-65 years old
- Sex
- Medically diagnosed health condition
- How symptoms are presenting
- Duration and severity of illness
- History of treatment
- Distance of participant to trial site
Common Exclusion Criteria:
- High blood pressure or BMI
- Presence of comorbid conditions
- Use of certain medications
- Allergies or inability to undergo certain procedures
- Pregnant or breastfeeding
These criteria are put in place to ensure that participants are prone to the least amount of risk throughout the course of the clinical trial, enhancing the safety of the trial as well as its effectiveness.
A participant may be excluded from a clinical trial if they have high blood pressure or BMI
Pre-Screening: The First Step in the Screening Process
After getting your clinical research diploma, you can begin the screening process by conducting pre-screening. Pre-screening happens after the eligibility criteria have been set, and involves contacting potential trial participants in order to determine whether they’re a good fit for the trial. Once individuals answer a pre-screening questionnaire, they may be selected for participation. Patients can complete a pre-screening questionnaire in two main ways, including:
- Online surveys: found on a trial website, a website’s newsletter, social media, a sponsor’s website, etc.
- At their doctor’s office: a doctor may help their patient to complete a questionnaire if they think their patient is appropriate for a certain trial
Once the pre-screening questionnaire is completed, successful candidates will be contacted by telephone. A clinical research coordinator will ask the subject further questions and gather specific information to make a more informed decision.
Pre-screening is conducted to determine the eligibility of a trial’s subjects
Completing the Screening Process
While the pre-screening questions may give coordinators a good idea of a participant’s eligibility, there are still two more steps to follow before they are deemed fit for a trial. First, participants must complete a screening visit, which often includes:
- A physical examination
- A medical history review
- Diagnostic testing
- Laboratory testing
Once these steps are complete, the participant must provide informed consent, which involves reviewing and signing a form. Once the form is signed, the individual is ready to participate in the duration of the clinical trial.
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