Step 1. Prescreening
Now that you’ve decided you want to participate in research, the next step is to call the research center and pass what the industry terms a ‘Prescreen’. You will be talking with a knowledgable recruiter who is an expert in the study protocol and design.
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The recruiter will do their best to explain the study to you and answer any questions about it
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The recruiter will ask you a series of questions to help ensure you would be a good fit for this particular research study
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If the recruiter thinks you will be a good fit, they will help you schedule an in-person screening visit
Step 2. In-Person Screening
So, you passed the prescreen and are about to come in for the screening appointment. What happens now?
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At CRC, you will first be handed an intake form where you will list relevant medical conditions and medications, as well as providing us with an optional medical records release form (if you want us to coordinate care with your PCP).
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The next step is going through and reading the informed consent. This is the document that will detail every detail of the study. It will go over previously reported side effects of the investigational drug/device, study sponsors, study investigators, what will happen at each visit, any compensation that will be provided, as well as any possible benefits or drawbacks in participating.
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If, after reading the consent, you decide that everything looks good, you will talk with a study coordinator or the study investigator so you can have any questions answered. You will then sign the document together to signify that you have been informed of the possible risks and benefits of participating in the study.
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Depending on the study, a multitude of things will happen next. Generally:
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Vital Signs will be taken (blood pressure, pulse, temperature, weight, height)
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Doctor Physical will be performed
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Medical History will be asked
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Medication History will be asked
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Often times a psychiatric questionnaire will be conducted
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Blood draw (usually to do a general health panel)
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Often times an ECG will be done
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Step 3. Scheduled Visits – Follow the Protocol
If you pass the screening, you are officially in the study. Study visits will then be scheduled with you. They usually have a timeframe in which they have to happen, IE. Once a week +/- 2 days, every 6 months, etc.
Some visits have special requirements: these will be explained to you before the appointment. Otherwise, a good participant will:
- Complete scheduled study visits as described in the informed consent.
Most visits will ask about any side effects, as well as having some scale or questionnaire to measure how well the medication/device is working.
- Take study medication as directed
- Report any side effects to study team
Step 4. Completion
- Once you complete all scheduled visits, you will have officially completed the research study. At this point, usually a post-treatment physical will be conducted, as well as blood work.
- The study coordinator will have you fill out a compensation sheet detailing where you will want your stipend mailed (Note: not all studies have a stipend).
- Some studies have an “Extension” study, which will allow a participant in the study to continue taking the medication for a longer duration. This is especially useful when the study medication has worked for you.
