WorksheetsCTM Training Quiz
Total questions: 27
Worksheet time: 11mins
True or False: Your study team can begin participant related activities, such as recruitment, before a protocol is approved by the IRB.
True
False
The coordinator for a study just realized that not all participants are being asked the same questions during an intervention. What is the first thing she should do?
Disregard all previous answers from participants and start again
Record the deviation, report it (per IRB’s procedures), and talk to the study team about the proper protocol
Gather all participants as soon as possible and ensure consistency by asking any questions that were missed
Continue the current process as is, but document the issue in log notes
True or False: All deviations are avoidable if you plan ahead
True
False
A PI is struggling to set a timeframe for follow up study visits. She thinks a check-in one month after initial visit is appropriate, but her coordinator recommends that the follow up occur at two months. What should be written down in the IRB protocol to accommodate both opinions?
One month – the IRB will require exact specifications
One month plus or minus one week – a range like this will minimize later deviations but include enough specificity with the IRB protocol.
3 months – it is beneficial to “pad” the estimate, so it will never run over the time listed in the IRB protoco
What is the importance of an SOP?
SOPs ensure team members know what, when, how, and why something must be done
SOPs ensure that every participant answers in the exact same way
SOPs detail the background and significance of the science behind a study
SOPs are submitted to grant-making institution before a study is funded
True or False: To make sure that enough participants are enrolled in your study, it is appropriate to persuade a participant after he/she has said he/she does not want to participate.
True
False
How can a study team member build trust with participants? Choose all that apply.
Communicate openly with them
Answer any questions honestly
Deviate from standard questions to personalize conversations
Keep commitments made to participants
Unfortunately, a participant has decided to leave the study. What is the first step you should take?
Ask the participant to help find a replacement
Refer to your clinical protocol to review the process for participants who are withdrawing
There is no action required – the study will be fine without one participant
True or False: The best recruiting efforts usually include multiple recruitment methods
True
False
Which of the following is a best practice when it comes to contacting participants? Choose all that apply
Asking if it is okay to leave a voicemail
Gathering several pieces of contact information from participants
Calling participants in the evening when you have more time
Asking participants how they prefer to be contacted
True or False: Participants are more likely to leave a study if they find involvement to be a hassle.
True
False
Your recruitment plan and materials are ready. What is the final step you should take before you begin recruiting participants?
Print 100 copies of your flyer so that they’re ready for posting
Have the materials and plan approved by the IRB
Turn on your online search engine ad
Start gathering contact information for potential participants
True or False: The use of other strategies beyond the consent form (such as videos and comprehension checks) can help enhance understanding of what study participation will involve
True
False
A PI has added an additional physical test to her study. The new test involves slightly different risks to her study participants. What is her best course of action?
Call each participant immediately and explain the new test and any possible risk, then obtain their verbal consent to continue participation in the study
To ensure that all participants receive the same verbiage, she must mail a revised consent to each participant with the new information highlighted
She must revise the consent form, then review the new form with each participant in a faceto-face conversation.
She must submit a revised consent, highlighting the new test and any associated risk, to her IRB, and continue to use the same methods previously used.
A research assistant (RA) is meeting with the potential study participant at the first visit to conduct informed consent. The participant is eager to begin, has read the informed consent at home, and is ready to sign their name and begin the first study assessment. What should the RA do?
Since the participant has read the correct version of the form, the participant may sign the form and proceed with the study.
The RA should ask several comprehension questions to ensure that the participant understood what they read at home.
The RA must walk through each section of the consent form during the initial visit, confirming the participant’s comprehension along the way
The RA must give the participant the printed consent form, then leave the room to allow him/her to read it again in private
. Which of the following are methods used to ensure participant comprehension? Choose all that apply.
Sending a copy of the consent form ahead of time for the participant to review
Using a 6th to 8th grade reading level when writing consent
Asking the participant to summarize or explain certain elements in their own words
Asking a family member to be present in order to give consent on behalf of the participant
True or False: To appropriately obtain an informed consent, the only people allowed in the room are the study team member and the potential participant.
True
False
True or False: A consent form is a legal document that can be signed by an adult 18 years and older; whereas an assent form allows minors to convey their own independent decision about participation.
True
False
Why might a participant need to re-consent?
The study procedures/assessments have changed
A significant amount of time has passed between visits
There are new participant risks to consider
All of the above
An adverse event is:
Always an unexpected event
Always an event that happens as a result of participation in a study
Any untoward medical event that occurs during a study, but may or may not be caused by a study
In general, what should be included in an adverse event report? Choose all that apply
Event date
Steps taken to address the event
The name of the participant involved
Whether or not the event was expected
True or False: Not all adverse events are always classified as serious.
True
False
True or False: Sonya has identified an adverse event that she believes is unexpected, not related to the research and not serious. She should report it to the IRB right away.
True
False
A participant in a study assessing the effect of relaxation techniques on overall mood has come to you with feelings of depression. The study began two weeks ago, but the participant has reported feeling depressed for the last several months. Because your team has defined a study-specific adverse event reporting plan, you know that depressive thoughts are a possibility for participants. How would you classify this event?
Related, expected, non-serious
Unrelated, unexpected, non-serious
Related, unexpected, serious
. Unrelated, expected, non-serious
Who is responsible for reporting an adverse event to the IRB?
PI
Research Assistant
Coordinator
Data Manager
Carla, a new coordinator, is having trouble keeping up with all the adverse event reports she need so give her IRB. How could she have made this situation easier on herself?
There’s nothing she could have done
She should have outlined a study-specific adverse event reporting plan
She should have waited to report these events after her annual review.
True or False: All participants in a study are expected to experience the study in the same way. Therefore, an adverse event in one sub-population is always an adverse event in another.
True
False
