Questions about the Research Coordinator Clinical Trainings?

Research Coordinator Trainings

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My research group has SOPs for clinical training. Do I need to replace those with this training?

First of all, GOOD JOB! No, if your research group provides training and documentation of that training you may continue with that process. The trainings and checklist provided here are for groups that do not already have a training and documentation plan in place.

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Can I watch the presentation again?

Yes….log on to MyLearning and click the training link for the course.

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If I am audited, what specific documentation am I required to have?

You should have copies of 1) statement of the content of the training with the date of training for each skill (this can be a written statement including the name of the training and the link), 2) copy of a completed competency checklist for each skill.

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What kind of compliance training would a summer volunteer need to take to work on our study?

That would depend on the skills they were going to use as part of the study. If they were doing Blood pressures you would need to have them complete training and competency for that skill. Remember, any person working with study participants must also be named on your IRB application as a study team member and take the required IRB training content.

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Where can I get information on the specific policies in the clinical space I use to conduct my research?

You should ask the clinical manager in the specific area that you are working in.

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How do I know if a procedure is minimal risk?

You can consult with the IRB if you have a question about a specific procedure not listed in the training. 410-955-3008

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How often does my research staff have to re-certify their training?

There are no specific requirements for retraining. A good rule of thumb is every two years. If a staff member is not performing the clinical task often (say hasn’t drawn blood for a year) you should consider retraining and/or an updated skills checklist.

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Can the training be done online?

Links to online training are provided on the ICTR website. Skills should be practiced in a “hands on” manner and checklists require physically preforming the skill for a trainer to observe and check off.

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Who will track the course completion?

Course completion for the brief module explaining the requirements will be tracked by the IRB through MyLearing. Specific skills training will be the responsibility of the PI and study teams.

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