Additional Site – Application Form
RESEARCH MODIFICATION / CHANGE FORM
CHANGE IN PRINCIPAL INVESTIGATOR FORM
CONTINUING REVIEW REPORT – SITE FORM
- 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.
FINAL STUDY REPORT – SITE FORM
- 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.
PROTOCOL DEVIATION / VIOLATION FORM
PRINCIPAL INVESTIGATOR AND RESEARCH SITE SUBMISSION FORM
RESEARCH SITE STAFF FORM
SERIOUS ADVERSE EVENT FORM
UNANTICIPATED PROBLEM FORM
HIPAA - Request for Waiver
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”.