Emory University Consent Form Checklist Please use this checklist to create your WIRB-ready consent/HIPAA form Language below must be inserted into master consent template Contact to determine if WIRB can provide their approved master consent for this study. If not, use master consent provided by Sponsor. Please check if any of these are Children’s Healthcare of Atlanta site locations for this submission. Grady Health System Saint Joseph’s Hospital Emory Johns Creek Hospital None of the above Procedures How will my medicine be provided? Is this an The medicine that you will take will be dispensed by the pharmacy and investigational delivered to the principal investigator or study team member. The drug study principal investigator or health care providers on his/her research team requiring IDS, for will provide the medicine to you. If you have questions about the which you HAVE medicine, you should ask the principal investigator or study nurse. You NOT received an may also call the pharmacy if you have questions about the medicine. IDS waiver? The number for the pharmacy is included on your medicine package, if given one. Yes (if yes, include this language at the end of the procedures section) No FOR ST If you are a woman of childbearing ability, you and the study doctor must JOSEPH’S AND agree on an adequate method of birth control or abstinence for the JOHNS CREEK duration of the study. (Catholic sites) ONLY: Risk If you are a man: You and the study doctor should agree on an adequate Language method of birth control or abstinence for the duration of the study. related to pregnancy + contraception Is either Saint Joseph’s
Emory University Consent Form Checklist Please use this checklist to create your WIRB-ready consent/HIPAA form Language below must be inserted into master consent template Contact to determine if WIRB can provide their approved master consent for this study. If not, use master consent provided by Sponsor. Please check if any of these are site locations for this submission. Children’s Healthcare of Atlanta Grady Health System Saint Joseph’s Hospital Emory Johns Creek Hospital None of the above Procedures Is this an investigational drug study requiring IDS, for which you HAVE NOT received an IDS waiver? Yes (if yes, include this language at the end of the procedures section) No How will my medicine be provided? The medicine that you will take will be dispensed by the pharmacy and delivered to the principal investigator or study team member. The principal investigator or health care providers on his/her research team will provide the medicine to you. If you have questions about the medicine, you should ask the principal investigator or study nurse. You may also call the pharmacy if you have questions about the medicine. The number for the pharmacy is included on your medicine package, if given one. FOR ST JOSEPH’S AND JOHNS CREEK (Catholic sites) ONLY: Risk Language related to pregnancy + contraception Is either Saint Joseph’s If you are a woman of childbearing ability, you and the study doctor must agree on an adequate method of birth control or abstinence for the duration of the study. If you are a man: You and the study doctor should agree on an adequate method of birth control or abstinence for the duration of the study.
Emory-checklist-08-22-18-for-IRB-website3.docx