07 Enrollment Education Product Use Instructions07入学教育产品的使用说明.pptVIP

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07 Enrollment Education Product Use Instructions07入学教育产品的使用说明.ppt

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07 Enrollment Education Product Use Instructions07入学教育产品的使用说明.ppt

Example chart note. * After providing product insertion instructions and answering any questions the participant may have, study staff will ask the participant if she is ready to try inserting the VR herself. Insertion should be performed in a private space, with study staff standing by in case the participant requests guidance or technical assistance. For participants who have difficulty or who have inserted the ring incorrectly, study staff should provide further information and guidance to address the difficulty encountered. This should be flagged within chart notes or the alert logs in the participant binder for active follow-up at subsequent visits. After guidance is provided, the participant should try again to insert the study VR at the enrollment visit. If she is unable, study staff may insert the VR for the participant. * Let group know that digit exam/confirming placement will be discussed in more detail with clinicians on Day 4. At the Enrollment Visit and Month 1 visit only, study staff are required to confirm proper placement of the VR by a digital examination, regardless of who inserted the ring. After ring placement, the participant should walk around (the room?) prior to verification of correct ring placement. The participant should then lie comfortably on the examination couch in supine position (on her back?) Upon genital inspection, the ring must not be visible on the external genitalia. If the ring is visible, the placement is not correct. The ring should not press on the urethra. On digital examination, the ring must be placed at least 2cm above the introitus beyond the Levator Ani muscle. ? At the Enrollment visit, after correct placement is confirmed, the clinician should ask the participant to feel the position of her ring. This will help ensure that she understands what correct placement feels like, should she need to check this between study visits. * Removal instructions are located in Tab 9 of your binder. * If, on inspectio