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.

Will staff receive a certificate upon completing the initial module? If so, where can this be downloaded?

Yes, a certificate is available and can be accessed on MyLearning.

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.

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.

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

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.

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.

If we train a study assistant to collect blood samples, is that person allowed to collect blood for other studies?

Yes- remember to keep a statement of the training and skills checklist on file!

We expect to have a student trainee perform basic assessments, (e.g., blood pressure, weight, temperature) for our study starting this summer. Where can I find criteria needed to assess his/her competency for each assessment?

Competency checklists are on the ICTR website for each skill.

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.

Can I watch the presentation again?

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