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Update December 7, 2009
As part of quarterly scheduled updates, the following changes have been made in eIRB:
- New Application – 29 Radiation Calculator – an additional page has been added to the application. The radiation calculator may be used to create a computation of total radiation does exposure and will create a radiation risk statement to be used in the consent form.
- Paper Conversion Applications – paper conversion applications in data analysis will be directed to the SKCC CRO Information page. If the application is cancer related answer YES to the first question. For the text box questions you may respond N/A.Revisions to the Exempt Wizard – minor revisions and clarifications have been made to the exempt wizard.
- Continuing Review – 5 Reporting Information – questions 1.0 and 2.0 have been revised to indicate whether the PI, study team member or JHM employee holds an IND or IDE and whether the IND or IDE annual report was submitted to the FDA.
- Continuing Review – 4 Study Population- instructions have been added on how to obtain the CRMS Continuing Review Enrollment Summary Report and a note has been added to indicate that the IRB does not want patient-specific information.
- New Application – 14 Consent and Waivers – Adults – adults has been added to the title of the consent and waivers page to clarify that this page should be completed for adults only.
- New Application – 14 Consent and Waivers – Adults – if survey/questionnaire research is checked text information that should be added to the questionnaire will appear.
- New Application – 14 Consent and Waivers – Adults – by indicating that written consent will be obtained by non-English speakers a new question has been to clarify if a short form consent will be used. If so, you must also indicate the type of form.
- New language has been added to the Problem Event Submit activity to instruct the PI and study team members not to submit individually-identifiable information about research participants in eIRB.
- The Not Human Subjects Research letter has been revised to indicate that if there are changes in the activity that may affect the determination; the JHM IRB should be consulted before making those changes.