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- Whom do we enroll as participants?
Anyone you can follow over the study period (24 months) and who is willing to perform the monthly exercises. We anticipate this will mostly be surgical trainees, but this could conceivably also include interested faculty. Trainees who rotate on a Pediatric Surgery service for only a few weeks or months at a time would not be good choices for participants.
- I enrolled a participant, but I did not receive the introductory email with the link to provide demographic data. Did I do something wrong?
The email is generated automatically in REDCap and sent the participant only at the Enrollment step.
- Is there a guideline about who can lead the formal teaching sessions?
The site director or his / her designee should facilitate the sessions. It is expected that the sessions will be led by a surgeon or other formal surgical educator.
- Do I have to submit a protocol to my Institutional Review Board (IRB) before enrolling participants?
The Nationwide Children’s Hospital (NCH) IRB has deemed this research exempt from regulation as Human Subjects Research. Most (but not all) IRBs should permit site participation by relying on that exemption. If you are unsure of your ability to participate as a site, contact your local IRB to confirm. No formal protocol has been prepared for this project, but we can certainly share the materials on file with the NCH IRB. Contact [email protected] for more information.
- Is there a consent form that participants need to complete?
We do provide information to participants regarding the research and its objectives in the introductory email. Completion of the Participant information survey completes voluntary enrollment, so there is no consent form required.
- I approached one of our trainees to participate and he / she refused. What should I do?
All participation is voluntary. Sites may not compel individuals to participate or utilize negative incentives (punishment or sanction) to encourage participation. If participants have questions or concerns regarding this project, they should contact the study staff at [email protected] .
- How do I set up the trainer boxes?
Printed setup instructions should be present among the materials shipped from KARL STORZ. If you need a copy of this documentation, please email [email protected].
- When should we start training sessions?
1 July 2018 is the project launch date. The initial baseline (TS-E) session should be completed in July and additional sessions should follow the project Timeline.
- Should I still perform the REDCap Testing described in the Site Checklist?
The testing period has now ended, only real participant data should be entered, starting in July.
- My site will not be ready to launch in July. What should I do?
Start enrolling participants as soon as you are able to perform the scheduled training sessions. You may follow a modified schedule, based on the project Timeline, but sessions must occur at the same intervals.
- Who can enter training session information into REDCap?
Either a Site Director or a designated Site Coordinator can enter data into REDCap. You must not share REDCap login credentials with others, even with other staff assisting in this project. If you need additional credentials created for a Site Coordinator, please email the following to [email protected] :
* User’s full Name
* User’s email address
* User’s postal address
* User’s telephone number
A temporary login will be created and emailed to the Site Coordinator, which will need to be activated before use.
- My site is having other trouble. Whom should I contact?
See the Inquiry Directory below.
- REDCap login issues: [email protected]
- Usage issues: NCH Service Desk – [email protected]
- Trainer Delivery: Ms. Nicole Von Husen (IPEG Office) – [email protected]
- Trainer Setup and Maintenance: [email protected]
- General Administrative: Ms. Nicole Von Husen (IPEG Office) – [email protected]