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.
Yes. Please log on to MyLearning and click the training link for the course.
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.
Competency checklists are on the ICTR website for each skill.
Yes and please remember to keep a statement of the training and skills checklist on file.
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.
You should ask the clinical manager in the specific area that you are working in.
You can consult with the IRB if you have a question about a specific procedure not listed in the training. 410-955-3008.
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.
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.
Yes, a certificate is available and can be accessed on MyLearning.
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.
Licensed or unlicensed study team members. Only people listed as study team members on an approved IRB protocol that has the requested skill will be able to request training.
No, It is required that a PI delegate a clinical task to adequately trained and qualified individuals. There is no JH definition of adequately trained or specifics of who can be trained.
It is recommended that training be documented and skills be signed off by someone with qualification to observe the performance of the skill. This can be accomplished with the PI observing and documenting adequacy, or a study team member who is qualified (like and RN with the skill or a phlebotomist.) Documentations such as the ICTR training or something from an outside institution or a memo to file that the PI has observed adequate skills in this individual would be another example.
ICTR clinical training for unlicensed individuals is one path forward. It is important that 3 things are in place:
- The performance of this skill is listed in the persons job description
- There is documentation of training
- There is documentation that the person was able to demonstrate the skill adequately after training.
