CTM Training Quiz

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