Show me the Form!
If a non-English speaking participant wants to enroll in a study and a fully translated ICF is not available, this is the alternative document that may be used to obtain consent, provided the IRB has approved its use.
What is Short Form?
In cases of dual enrollment with Prompt Bolus, collecting these for PedCAPS is strictly off-limits.
What are Specimens?
This study compares the effectiveness of two different medications for treating a tick-borne illness that can lead to meningitis.
What is Lyme Meningitis?
Anything with a biohazard label (including biohazard bags) clean or soiled goes into this specific bin.
What is the Biohazard Bin?
This is the name of the device used to record data points during the psychophysiology component of the ED-CAT baseline activities.
What is the Data Logger?
In situations where a research participant lacks decision-making capacity, this person may provide informed consent on their behalf—according to applicable laws and institutional policy.
What is an LAR or Legal Authorized Representative?
An 8-year-old comes into the ED complaining of a headache and fever. Their provider has ordered a Lyme test and has expressed concern for CNS Lyme. This is the next step for the research assistant.
What is give a pre-enrollment sheet to the family?
This study utilizes the DSM-5 Criterion A for Post Traumatic Stress Disorder (PTSD).
What is ED-CAT?
This is the designated container for disposing of used blood collection tubes in the research lab.
What is the Sharps Bin?
If the participant is under 18 and randomized to the Addinex device, the Addinex application should be downloaded to this individual’s phone.
Who is parent or guardian?
This term stands for the special regulatory allowance that permits the enrollment of participants in life threatening emergencies when consent cannot be obtained in time.
What is EFIC?
A potential EMPOWER patient comes into the RIH ED with chief complaint “Detox/Suicidal”. This is the type of SI we should be looking for in the Psych report to deem this patient ELIGIBLE.
What is passive SI?
These two studies share a similar criterion—linked to systemic treatment—that helps ensure study outcomes aren’t confounded by compromised immune function or bone fragility.
What is Geriatric Rib Fx and PedCAPS?
For PedCAPS, this is the range of hours the EDTA tube should be processed within after blood draw.
What is 4-6 hours?
For female participants in the NiADA study, this additional biological information must be documented in the application before proceeding.
What is Pregnancy Status?
This federal law, mentioned in some consent forms, protects research participants from discrimination based on their genetic information in health insurance and employment.
What is The GINA Statement (Genetic Information Nondiscrimination Act)?
A patient comes into the ED after a traumatic fall on the playground complaining of head trauma and severe 10/10 abdominal pain. After ultrasound, they identify clear intra-abdominal bleeding. They report no LOC and are GCS 15. This is the cohort of BOPPED II this patient is most eligible for.
What is Cohort 4?
You are screening patients on a sunny Friday afternoon, and someone who is 62 years old arrives s/p an MVC c/o back and arm pain. These are the two studies should you monitor them for when determining eligibility.
What is Oasis and Addinex?
When centrifuging (aside from Cancer team samples), this is the temperature range the centrifuge should remain set to, in Celsius.
What is 20-22 degrees Celsius?
Before recording a video for CurieDx, this camera setting should be verified.
What is Ultrawide Angle?
Federal guidelines mandate that this section, placed at the start of a consent form, highlights the most important facts to help participants decide whether to join a study.
What is Study Key Information?
When screening a potential candidate for Prompt Bolus, checking available lab values is critical to observe for abnormally high levels of calcium and potassium. According to our exclusion criteria, these values would make a patient hypercalcemic.
What is total Ca2+ >12 mg/dL or ionized Ca2+ >1.35 mmol/L?
A 72-year-old patient comes into CC with respiratory symptoms (e.g., cough, dyspnea), abnormal chest imaging (e.g., infiltrates or consolidation), and a clinical diagnosis of pneumonia per provider. The patient is eligible for these two studies.
What is CurieDx and PAX?
This is the maximum amount of cryovials you may use for each serum and saliva for the BOPPED study.
What are 6 cryovials?
This is the correct numerical aperture the EDema lense should be set to.
What is 4?