Informed Consent
What system will you typically use to obtain the informed consent form?
PTrax
True or False: All research studies can consent participants remotely
False
What does the acronym ALCOA+ stand for?
Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available
You're consenting a patient to a study. They have many questions and seem hesitant to join. However, their partner is really pushing them to join and keeps telling them to just sign the form and do it. What basic element of informed consent does this violate?
Participation is voluntary.
Your PI has identified a potential new participant for a study. After prescreening the patient, you decide that the patient might be a good candidate and add them to PTrax. What is the participant's current PTrax status?
Consent Prepared
Omar was recording a patient's vital signs information on a paper source document. He accidently recorded the time as 10:45 AM when it should have been 10:54. He caught his mistake and crossed out the incorrect information with one line. What must he do to finish his correction?
Initial and date the error.
How should consent visits be documented?
The visit should be documented in Epic using the enterprise consent smartphrase
What status will a patient be in once consent is registered in PTrax?
Enrolled
Omar consented a patient on Friday afternoon. It was the end of the day, and he didn't have time to document the consent in Epic. He then went on vacation for three weeks and didn't create the note before leaving. What ALCOA+ attribute did Omar violate?
Contemporaneous
After taking the study medication, the patient's lab values were elevated and they had to be admitted into the hospital. Their family wants to know whether this admission is covered by the research study. What document would you review and what section of the document would you refer them to?
The informed consent form, section 8. What if you are injured from your participation in this research study?
Your patient has consented to the study, passed all of their screening testing, and is now ready to begin the active phase of the study. What should you update the patient's status to in PTrax?
Accrued
What is the correct procedure for providing copies of the Informed Consent Form (ICF) to patients?
Study teams must provide patients with a signed and dated copy of the ICF
Your patient wants to know what the most common side effects of the study drug are. What document would you review with them and what section of the document would you refer them to?
The informed consent form, section 6. What are the possible risks or discomforts from being in this research study?
Within how many days of IRB approval must a study be set up in PTrax?
30 days
When you create a source document, what information must be contained on every page?
The subject information should include at least two identifiers such as subject ID and initials on every page. Create footer containing correct version, appropriate signature(s), date, and page numbering.