Medical screening is a crucial part of a Clinical Trial participant’s journey. It is the process where researchers evaluate a participant’s health and medical history to determine whether they meet the eligibility criteria for the trial. The screening appointment typically takes place a week after the initial prescreening over the phone. During the appointment, participants are required to undergo a series of tests and procedures, including blood and urine tests, physical exams, and medical history questionnaires.

Once the screening is complete, clinical trial participants will be notified of their results within 2-3 business days. If they pass the screening, they will proceed to the next stage of the trial, the check-in process. During check-in, clinical trial participants are checked in by clinic staff and undergo vital sign checks to ensure their health has not changed since their last visit.

The daily routine of a clinical trial participant can vary depending on the type of study they are in and the stage of the trial. Participants typically need to prepare for two different days in their clinical trial journey. Day one would be their medical screening and day two is study check-in.

1:00 PM (one week before screening) – You get a text!

Before a clinical trial participant can check into a medical screening appointment or study check-in, they would need to call our recruitment line (416-747-5246). All new and existing participants are alerted about studies via text or email, which will prompt you to call in for more information.

On the phone, one of the recruiters will conduct a pre-screen that goes over general health questions. This gives us a chance to rule out any clinical trial participants that might not be qualified due to any medical conditions, dietary restrictions, or serve allergies.

During this pre-screening process, participants are given important information about the study such as the schedule of the trial, name & purpose of medication, compensation, and whether it’s a fasted or fed trial.

1:15 (one week before screening) – You’re booked!

You’re booked for the next month at 10:00 AM! Once deemed qualified, you will be booked for a medical screening on a date that is generally one week after the pre-screening over the phone.

You will receive an email from the recruiter which highlights the time and date, restrictions, and items to bring to your medical screening.

8:30 AM March 16th (day of medical screening)

Before you leave for your medical screening, look at the distance from your house to the clinical. If you are running more than 15 minutes late to your medical screening, you need to call and reschedule your screening appointment to a later time.

Ensure you follow all the restrictions. No caffeine on the day of the medical screening, no foods or drinks containing poppy seeds at least 2 days before screening. You should not have done any strenuous exercise three days before the screening appointment.

If you feel like you might’ve missed something or are unsure, don’t hesitate to reach out.

9:00 AM March 16th

Double check to make sure you have packed a photo ID and health card. The receptionist at the screening will ask you to present both these items. If you do not have a Canadian health card, you will be asked to present valid health insurance that covers hospital visits.

If you were asked to bring any doctor’s notes, please make sure to bring that along as well.

10:00 AM March 16th

Once you arrive at the clinic, you will enter through the “Volunteer Entrance” on the right side of the building. After you enter, the receptionist at screening will complete a covid questionnaire and temperature check. You’ll be given paperwork to fill out, such as the registration form.

After the forms are filled out, you’ll need to do an RSVP check with your thumb fingerprint to ensure you’re not participating in any other study. You’ll be given a subject information package (SIP) and an informed consent form (ICF).

These documents will go into detail about the trial and all the procedures that will be performed. If at any point you do not feel comfortable, you can always withdraw from the study.

11:00 AM March 16th

The first step during the medical screening will be to measure your BMI (Body Mass Index). This calculation is based on the height and weight of the clinical trial participant. BMI is calculated over the phone, but needs to be checked again when you are in the clinic.

After the BMI is confirmed, you will be taken to the vitals’ room, where they measure your blood pressure and heart rate. It is important to remain calm when taking vitals to ensure the most accurate reading.

12:00 PM March 16th

An ECG (electrocardiogram)* test will be taken, along with a breathalyzer to test for any alcohol in your system. The medical screener will conduct a medical history questionnaire.

And finally, you will do a physical exam with the doctor, along with providing blood and urine samples. Your medical screening will be done at this point, and you will be required to call our results line in 2-3 business days to get your results.

1:00 PM March 19th (3 days after screening)

You will call us at our recruitment line and select 2 for our results department. You will proceed to ask for your results for the latest screening you just completed.

We have two types of clinical trial participants: those who have confirmed spots and will definitely receive the dose, and those who are on standby and will only receive the dose if other participants are unable to participate in the study. The standby participants need to check in, but their participation is not guaranteed.

Congrats you passed! — You are Subject Number 7, and we’ll see you at check-in on March 21st at 3:00 PM

2 PM March 21st (Day of Check-in)

Make sure you pack your toothbrush, change of clothes, and anything that can make you comfortable during your stay. Consider bringing a good book or a laptop with your favorite movies/shows downloaded. Check our packing list to learn what you can and what you can’t bring.

Make your way down to the clinic at an appropriate time to avoid being late and losing your confirmed spot.

3:00 PM March 21st

All clinical trial participants will be checked-in by the clinic staff, and vital signs such as blood pressure, pulse, and temperature will be taken. They will also check for any changes in the participants’ health since the last medical screening visit.

After all the check-in procedures are completed, you will be taken to the sleeping area, where participants will have the opportunity to get settled and prepare for the morning.

It’s important to get a good night’s sleep as participants will receive the study drug (dosing) at 8:00 AM.

8:00 AM March 22nd (Dosing Day)

Since the trial is a fasted one, you will skip breakfast and have your vitals taken one more time before receiving your first dose of the study drug. The clinic staff will explain how you will be taking the medication and what you need to do after being dosed.

As you will have reviewed the ICF you should be familiar with some of the procedures that follow dosing. All clinical trial participants are dosed in the order of their subject numbers, since you are #7, you will be the seventh person to be dosed.

After you are dosed, the clinic staff will do blood draws and carefully monitor all participants for any reactions to the medication. Our expertly trained clinic staff is prepared to manage all the steps of the procedure, including cases of adverse reactions, with both expertise and compassion.

12:00 PM March 22

Lunchtime! Time to eat and refuel. Our staff will bring you food during your stay in the clinic. No need to bring your own food because we provide all meals (including lunch, dinner, and snacks) during the trial.

We will offer standardized meals, and we screen for any food allergies or hypersensitivity during our telephone pre-screening to ensure participation eligibility.

1:00 PM March 22nd

After lunch, you will be providing blood samples at certain time points.

You will have a lot of downtime for the rest of the afternoon, and now can enjoy your favorite books or movies.

8:00 AM March 23rd (Check out)

Before leaving the clinic, you will be asked to provide one more blood sample. Once the blood sample is collected, you will be given a compensation cheque for your valued time and commitment. This may be a partial payment if return visits are scheduled.

If there are any return visits or multiple periods in the study, you will need to attend those to receive the full compensation outlined in the ICF.

Conclusion

Medical screening plays a critical role in ensuring the safety and effectiveness of clinical trials. It allows researchers to carefully select participants who meet the eligibility criteria and are likely to benefit from the study. By understanding the medical screening process, participants can prepare accordingly and ensure a successful journey through the trial.

Being a clinical trial participant can at times require a significant time commitment. While it is a lengthy process, it is a rewarding one – participants play an important role in advancing medical research and help improve the lives of people with various health conditions.

*ECG is a painless test that checks the heart’s electrical activity using electrodes on chest, arms, and legs.

Written by Gurtej Nijjar, Clinical Research Recruiter at BioPharma Services.

BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with access to healthy volunteers and special populations.