Radiation Risk Statements

Radiation Risk Statements for Adults

(1) Select the radiologic examinations used in your protocol from the drop-down lists in the "Study"column. You can select up to three different studies for each of the four major categories (x-ray, nuclear, fluoro or CT), and you can select studies from more than one major category.

(2) The small boxes in the "#" column can be used OPTIONALLY to enter the number(s) of each type of study to be performed. For just one (1) instance of a selected study, you can leave the box "as is". If TWO studies are required, enter a "2" in the box, and so forth. If your protocol design is 'open-ended' and you do not beforehand how many exams a patient may receive, then enter the maximum number of each study required by the protocol in the boxes, and select the protocol design using the radio buttons.

Typical values for the administered radioactivity for nuclear medicine exams are supplied automatically, and appear in the boxes in the "mCi" column when you select a nuclear medicine study. However, you can supply your own value for administered radioactivity by entering the new value (in millicuries) in the box. To accept the typical values, just leave the boxes "as is".

(3) Check this box if your protocol calls for one or more research-related MRI scans to include an "MRI risk statement".

(4) Select the predominant gender (if any) of your study population. For example, a protocol studying patients with prostate cancer would have a male predominance.

(5) Select a wording format for your study. Select "Choose For Me" to let the computer pick a suitable option.

(6) If your protocol contains diagnostic x-ray, nuclear medicine or MRIs that are considered "standard of care" and may be done regardless of whether or not the potential subject participates in the study, then check all the boxes that apply.

(7) Check this box to include the actual radiation dose (in mSv) in your risk statement.

(8) Check this box to include a quantitative cancer risk estimate based on BEIR VII "lifetime attributable risk" tables in your statement.

(9) Select whether or not your study is an oncology protocol, and the radiation exams are used to evaluate cancer extent or follow cancer treatment.

(10) When the form is complete, click the "Create Statement" button. If you want to clear the form and start over, click the "Reset Form" button.

Data Entry Form

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Copyright 2000, 2010, Robert E. Reiman, MD, OESO and Duke University Medical Center. All rights reserved.