eMedicus Forms for Download

Additional Site – Application Form

Complete this form when submitting an Additional Site for an approved Principal Investigator for review to the eMedicus Institutional Review Board.
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RESEARCH MODIFICATION / CHANGE FORM

Use this form when making any changes to an approved research study. Changes include Site Modifications, Product Information, Advertisement/Recruitment Materials, the Protocol, and the Informed Consent Document. Please indicate which research component(s) or protocol element(s) you are changing. Check all that apply.
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CHANGE IN PRINCIPAL INVESTIGATOR FORM

Complete this form for each Principal Investigator and Research Site submitted to the eMedicus Institutional Review Board. All information must be completed and the form must be signed by the Principal Investigator prior to submission. Refer to the HIPAA Section of the eMedicus IRB website for the Authorization Form, and the Waiver Form. Check all that apply.
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CONTINUING REVIEW REPORT – SITE FORM

This protocol is scheduled for Continuing Review. Please provide the following on your site:
  • This form must be signed by the Site Principal Investigator or Co-Investigator.
  • If you have Additional Sites, please include data for all sites on this form.
  • Attach a Complete Copy of the informed consent document signed by the last subject enrolled.
  • If you have not enrolled any subjects, please attach a Complete Copy of the current IRB approved informed consent document.
Check all that apply.
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FINAL STUDY REPORT – SITE FORM

Please complete this form when you are reporting to the eMedicus Institutional Review Board that the study has been completed at your site.
  • All information must be completed and submitted within 30 days of the end of the study or 30 days prior to the Approval Expiration Date.
  • The form must be signed by the Site Principal Investigator or Co-Investigator.
Check all that apply.
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PROTOCOL DEVIATION / VIOLATION FORM

Use one form to report each Protocol Deviation/ Violation. All Protocol Deviations/ Violations must be reported within 10 business days of when your site became aware of the event.
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PRINCIPAL INVESTIGATOR AND RESEARCH SITE SUBMISSION FORM

Complete this form for each Principal Investigator and Research Site submitted to the eMedicus Institutional Review Board. All information must be completed and the form must be signed by the Principal Investigator prior to submission. Refer to the HIPAA Section of the eMedicus IRB website for the Authorization Form, and the Waiver Form.
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RESEARCH SITE STAFF FORM

This form must be completed for each Principal Investigator / Research Site being submitted to the eMedicus Institutional Review Board. This form must list all Research Staff that will be participating in the informed consent process or performing study related procedures. It is the responsibility of the Principal Investigator to notify the eMedicus Institutional Review Board of any changes.
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SERIOUS ADVERSE EVENT FORM

The eMedicus IRB requires that all Adverse Events that are Serious and Unexpected and that are Related or Possibly Related to the subject’s participation in the research study at your site be reported. All Serious and Unexpected Adverse Events that occur at your site must be submitted within 10 days of becoming aware of the event. All fatal or life threatening events should be reported immediately.
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UNANTICIPATED PROBLEM FORM

The eMedicus IRB requires that any Unanticipated Problem involving risk to human subjects or others must be reported. Any Unanticipated Problem that occurs at your site must be submitted within 10 days of becoming aware of the event.
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HIPAA - Request for Waiver

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HIPAA - Authorization

During your participation in this research study, the Principal Investigator who is the physician responsible for the research study and the Research Team or study staff will collect and/or create personal health information about you. Examples of personal health information include your medical history, test results, examinations or procedures you will have while in the study. This information will be kept in your study-related medical records.

Your medical record also includes other personal information that identifies you and relates to your past, present and future physical and mental health and conditions. This includes personal information such as your social security number, date of birth, driver’s license number and medical record number etc. Health information that could identify you is called “protected health information”.

Under the new Federal law, known as the Privacy Rule your physician, the health care institution, its affiliated hospitals, researchers, health care providers and physician networks are required to protect the privacy of your “protected health information”. Any “protected health information” that is created or obtained during this research study cannot be “used” to conduct or carry out the research or “disclosed” which means to give or share with anyone your protected health information for research purposes without your permission. This permission is called an “authorization”.

To participate in this research study, you must give the Principal Investigator who is the physician responsible for the research study and the Research Team or study staff your permission to “use” and “disclose” (to give or share) your “protected health information”.

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Bedford MA 01730
Phone: 781-275-3403
Fax: 781-402-0201

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