Radiation Safety Committee Review of Research Protocols Involving

Radiation Safety Committee Review of Research Protocols Involving The Administration of Radiation to Human Subjects

Revision 2, August 6, 2013

CONTENTS: 1. Submission Instructions and Guidance……………………………….……………………1 2. Radiological Procedures Form…………………………………………………………..…...3 3. Application for Use of Radiopharmaceuticals in a Human Research Protocol……..….4 4. Flow chart showing process of submission to Radiation Safety………………………....5 5. Definitions and Acronyms…………………………………………………………………….6 6. Sample Risk Language………………………………………………………………………..9 7. Determining Radiation Dose………………….……………………………………………..10

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[Type text] Radiation Safety Committee Review of Research Protocols Involving The Administration of Radiation to Human Subjects

SUBMISSION INSTRUCTIONS AND GUIDANCE

Determine if Review Required Under certain circumstances, even if a protocol requires the administration of radiation to humans, a review by the University of California Irvine Medical Center (the Medical Center) Radiation Safety Subcommittee on Protocols (RSSP) is either not required, or the protocol must also be reviewed and approved by the Radioactive Drug Research Committee (RDRC). 1) To assist in evaluating whether or not a protocol requires review by the RSSP, the Radiation Safety Office has developed the attached flowchart, “Flowchart for Radiation Safety Review of IRB Protocol Submissions.” 2) In brief: a) If all procedures using radiation on human subjects are “standard of care” (the subject would undergo all these procedures even if they were not enrolled in the research study), then there is no review needed by the RSSP; b) If any procedures using radioactive materials are not an approved U.S. Food and Drug Administration (FDA) use, and not performed under an FDA “Investigational New Drug” (IND) exemption, then the protocol must be submitted to the RDRC, in addition to the RSSP; c) Please refer to the attached flowchart for more detailed information.

Submission Materials 1) Unless exempted, as discussed above, to use radioactive material or machine-produced radiation in any study involving the administration of radiation to humans, you must submit the following documents electronically to the Medical Center’s Radiation Safety Officer, and you must receive approval from the RSSP (or the full Radiation Safety Committee (RSC) before beginning the study: a) The “Radiological Procedures Form” (see page 2 of this document); b) If the study includes the administration of radiation from radioactive materials, the application on page 3 must be completed, signed and submitted; c) If the study includes the administration of an investigational radioactive imaging agent, the use of which is sponsored by the manufacturer of the imaging agent, the acceptance letter from the FDA must be included; d) If the study includes the administration of an investigational radioactive imaging agent, the use of which is sponsored by the investigator, the full IND application must be provided along with the FDA acceptance letter; e) The protocol narrative; f) Informed consent documents; g) A copy of any special imaging procedures (e.g., where the sponsor or investigator requires information in addition to that included in a standard radiology report, or requires imaging parameters different than the standard radiology protocols, or includes other special instructions involving the preparation of the patient for imaging or special collection or processing of the imaging data); h) The master protocol (if applicable); 2) Protocol submissions that include use of an investigational radiopharmaceutical must be specific to the proposed study, including the form of the radiopharmaceutical, the dosage, and the indications for use. 3) In developing the protocol narrative or supplement to it, researchers should consider whether certain procedures using radiation can be replaced by other procedures that do not use radiation. For example, to reduce study subject dose, it may be appropriate to replace a computed tomography (CT) scan with Magnetic Resonance Imaging (MRI), or to replace a Multiple Gated Acquisition (MUGA) scan with an electrocardiogram. 4) The Medical Center’s Radiation Safety Officer is Barbara Hamrick. Documents should be submitted to her at [email protected]. She can be reached by telephone at 714-456-5607.

of 11 Radiation Safety Committee Review of Research Protocols Involving The Administration of Radiation to Human Subjects

SUBMISSION INSTRUCTIONS AND GUIDANCE (CONT.)

About the Review – Including Submission Deadlines The RSSP may receive the submission materials at any time. If the research involves routine radiological procedures and a total effective dose below 3 – 5 rem, the submission will usually only be reviewed by the RSSP, and approval memoranda are provided within about 7 – 10 days if all the required information is provided. If the protocol involves investigational radiopharmaceuticals (or otherwise non-routine procedures), or involves a dose greater than 3 – 5 rem (depending on the subject population), the protocol may need to be submitted to the full RSC for review (see the Flow Chart on page 4 for additional information on when a full RSC review is needed).

The full RSC will meet monthly (during the third week of the month) to consider protocols requiring full RSC review. In order to provide adequate time for the preliminary and full RSC review, protocols must be submitted no later than 5:00 pm Pacific Time on the 3rd day of the month in which the investigator is requesting review (there is no extension for weekends or holidays).

During the preliminary review, there may be a request for additional information or clarification. These should be answered promptly to ensure the full RSC has the information necessary to review the protocol. If the protocol or supplemental documentation is so deficient that the full RSC determines it cannot be reviewed, the submission may be returned to the investigator, and may be revised and resubmitted for consideration during the next month. . Note: If you have any questions about the submission process you should consult with the UCI or UCI Medical Center Radiation Safety Officer.

Campus Radiation Safety Officer UCIMC Radiation Safety Officer Richard Mannix, M.S. Barbara Hamrick, C.H.P., J.D. Irvine, CA Orange, CA (949) 824-6098 (714) 456-5607 [email protected] [email protected]

RADIOLOGICAL PROCEDURES FORM

Table 1. Radiological Procedures using Machine-Produced Radiation (e.g., X-ray or Computed Tomography) Type of Procedure Location Number of these Effective Dose per Procedures (that are Procedure (millirem) not standard of care) Sample 1 CT scan w/o contrast Head only 2 200 Sample 2 Standard X-ray Chest only 1 10

Table 2. Radiological Procedures using Radioactive Material (e.g., nuclear medicine bone scan or PET scan) Type of Location Isotope and Activity per Number of Critical Critical Effective Dose Procedure Compound Procedure these Organ Organ Dose per Procedure (millicuries) Procedures per (millirem) (that are not Procedure standard of (millirem) care) Sample 1 PET scan Head only F-18 FDG 10 2 Urinary 6,000 700 Bladder Sample 2 Nuclear Bone of Tc-99m 20 1 Bone 3,500 450 Medicine the whole MDP Bone Scan body

APPLICATION FOR USE OF RADIOPHARMACEUTICALS IN A HUMAN RESEARCH PROTOCOL

HS No. Lead Researcher: Study Title: 1. List the radioactive drugs used in this study; use additional paper, labeled “Item 1,” if necessary: Name of drug: Isotope: Name of drug: Isotope: 2. Does this study include any procedures using radioactive drugs that are not approved by the U.S. Food and Drug Administration (U.S. FDA) for the specific procedures in this study? (NOTE: You should answer yes if the drug is either not FDA approved or the use in this study will be off- label.) Yes Go to question 3 No Go to question 6 3. Does this study include any procedures using radioactive drugs that are not approved or being used off-label, and are being used under a U.S. FDA issued Investigational New Drug (IND) number? Yes No 4. Does this study include any procedures using radioactive drugs that are not approved or being used off-label, and are not being used under a U.S. FDA issued IND number? Yes No 5. Provide the name (isotope and compound) and IND number or date of submission to the Radioactive Drug Research Committee for each investigational radioactive drug and each radioactive drug used off-label in this study: Name: IND No. Or, Date submitted to RDRC: Name: IND No. Or, Date submitted to RDRC: 6. Does this study involve any non-standard preparation of the radioactive drugs or the patient, or any interpretation of (or data from) the nuclear medicine images that would fall outside the routine nuclear medicine report? (NOTE: If you answered “yes” to question 2, you must also answer “yes” to this question; if you answered “no” to question 2, you may still need to answer “yes” to this question.) Yes Complete Items 7 and 8 below No Complete Item 7 below 7. Please sign below: By signing below, I affirm that the above information is true and correct, and that I have provided the information required by Item 6, above: Lead Researcher (Print Name) Lead Researcher (Signature) Date

8. Provide the name of the authorized user physician that will order the radiopharmaceutical, supervise the administration of the radiopharmaceutical, and for diagnostic administrations provide the interpretation of the study. The physician must be 1) named on the University of California Irvine (UCI) or UCI Medical Center radioactive materials license, 2) authorized to perform the procedure involving radiopharmaceuticals in this study, and 3) included as a co-researcher on the protocol. The physician must agree in writing to this participation, by co-signing this application below. By signing below, I affirm that I am named on the University of California Irvine (UCI) or UCI Medical Center radioactive materials license and am authorized to perform the procedure involving radiopharmaceuticals in this study, and understand I will be included as a co- researcher on this protocol: Radioactive Authorized User (Print Name) Authorized User (Signature) Date Material License

of 11 Radiation Safety Committee Review of Research Protocols Involving The Administration of Radiation to Human Subjects UCI UCIMC FLOW CHART FOR RSSP AND RSC Research Protocol ready for submission to IRB REVIEW Protocol Narrative and Informed Consent (HS# 20XX-XXXX)

Does the protocol include any radiological procedures? STOP! No NO RSC Yes No REVIEW REQUIRED Are any of the radiological procedures above and beyond the standard of care for any of the subjects in the study?

Do the research-related radiological procedures use radioactive drugs only for the purpose of basic research, Submit to Radioactive Drug and not under an Investigational New Drug (IND) exemption Yes Research Committee and to issued by the US Food and Drug Administration? RSSP.

No Continue with RSSP Submission

Submit required Do the research subjects include documents (see RSSP minors, normal adults, or a novel Submission Materials procedure? on Page 1) Review

No Yes Is the total dose from all research-related radiological Do the research-related radiological procedures to the maximally exposed individual procedures present greater than “minimal greater than 3 rem (or greater than 5 rem for treatment- risk”? study subjects with metastatic disease) for the entire study?

No Yes Yes No

RSSP review of risk Study submitted for RSSP Review of risk language related to RSC Review language related to radiological procedures radiological procedures

RSC review and vote

Results sent to Lead Researcher Underlined terms are defined on the next page.

Definitions and Acronyms:

1) “Basic research” means the research is intended to obtain basic information regarding the metabolism of radioactive drugs including kinetics, distribution, dosimetry, and localization, or obtain basic information regarding human physiology, pathophysiology, and biochemistry of radioactive drugs; and, the research is not intended to determine the safety and effectiveness of the drug, and is not for the immediate therapeutic, diagnostic, or preventive benefit to the human study subjects. 2) “Informed consent” involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. It is the researcher’s responsibility to provide the information necessary to a study subject to make a personal decision as to whether or not the risks of participating in a study are acceptable. For detailed information on the Informed Consent process at UC Irvine Medical Center, please visit the Office of Research Administration web page at: http://www.research.uci.edu/ora/hrpp/requiredelements.htm. 3) “IRB” is an acronym for the Institutional Review Board. There are three IRBs associated with UC Irvine and the Medical Center (IRB A, IRB B and IRB C). IRB A and IRB B review biomedical research protocols, while IRB C reviews social and behavioral research protocols. For additional information, please visit the Human Research Protection Programs web page at: http://www.research.uci.edu/ora/hrpp/index.htm. 4) “Lead researcher” means the person with primary responsibility for meeting all ethical, scientific, and regulatory requirements for the conduct of a UCI research study, whether or not acting as the Principal Investigator for the award that funds the study. 5) “Maximally exposed individual” means the individual human research subject potentially exposed to the greatest amount of radiation throughout the entire course of the study. For example, if the study includes optional radiological procedures, or includes a requirement to repeat a radiological procedure (if the first procedure is not useful or effective for some reason), then the “maximally exposed individual” would be the hypothetical individual that submits to all required and optional radiological procedures, and has each procedure performed twice (because the first procedure is not useful or effective). 6) “Minimal risk” as defined by the University of California IRB means a risk “where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in the daily lives of the general population or during the performance of routine physical or psychological examinations or tests. (NOTE: For the purposes of the RSSP or RSC review, the determination of whether a radiation exposure is no greater than minimal risk will be made by the RSSP or RSC. In general, the RSSP and RSC consider exposures up to 50 millirem for adults and 10 millirem for minors as posing no greater than minimal risk, based on a) the lack of short-term or deterministic harm, b) the low magnitude of the absolute risk, and c) the fact that the magnitude of the risk is consistent with other types of risks encountered in daily life. The assessment of risk may depend on the study population, and it is important to note there are at least three classes of subjects requiring special assessment: a) children, b) fetuses, and c) prisoners.) 7) “Minors” means persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. In California, 18 is usually the legal age at which people can consent to treatments or procedures; however, there are exceptions regarding treatment or prevention of pregnancy, or involving competency of the individual, among other circumstances, and further information may be required to proceed. It is the lead researcher’s responsibility to ensure that subjects are competent and legally able to provide consent, or that one or both parents or legal guardian is legally authorized to provide consent. 8) “Normal adult” means adult volunteer subjects used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with subjects who do have the condition. "Normal" may not mean normal in all respects. For example, patients with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism, cognitive development, and the like. Similarly, patients with heart disease but without diabetes may be the "normals" in a study of diabetes complicated by heart disease.

of 11 9) “Novel procedure” means any procedure involving the administration of radiation to humans that is non-routine, or a procedure involving two or more drugs that are not already approved by the U.S. Food and Drug Administration for the intended use (e.g., a study of one investigational drug that incorporates a sub-study using a second investigational drug). This may include procedures that involve the administration of an approved radioactive drug or performance of a routine radiological procedure, but requires non-standard preparation of the drug or the patient, or any interpretation of (or data from) the nuclear medicine or other images that would fall outside the routine nuclear medicine or radiology report. 10) “Protocol Narrative” means the non-technical description and summary of the proposed research. There are Protocol Narrative templates available through the Office of Research Administration at: http://www.research.uci.edu/ora/forms/. 11) Radioactive Drug Research Committee is an institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. If the purpose of the study is to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug, or regarding physiology, pathophysiology or biochemistry, and the study is 1) not intended for immediate therapeutic, diagnostic or similar purposes, or 2) not intended to determine safety and effectiveness of the drug in humans for therapeutic or diagnostic purposes (i.e., a clinical trial), then the protocol must be reviewed by the RDRC. Please refer to Part 2, Section L at the IRB web-site “Instructions for Submitting and Completing the Application for IRB Review” at: http://www.research.uci.edu/ora/forms/irb_irbapp_instructions.htm. 12) “Radiological procedures” means any of the following: a) A clinical or research procedure involving the exposure of human subjects to machine-produced radiation, including, but not limited to, the following procedures: i) X-ray procedures; ii) Computed Tomography (CT) procedures; iii) Dual-Energy X-ray Absorptiometry (DEXA) procedures (bone densitometry); iv) Fluoroscopic procedures; v) Mammographic procedures; vi) Therapeutic procedures involving exposure to x-ray beams, electron beams, proton or neutron beams; b) A clinical or research procedure involving the exposure of human subjects to radioactive materials internally or externally, including, but not limited to, the following procedures: i) Nuclear Medicine procedures; ii) Positron Emission Tomography (PET) procedures; iii) The administration or implantation of any radioactive material in a human subject (other than the normal concentrations of radioactive material found in the environment); iv) The external exposure of any human subject to radiation from any radioactive material (other than the normal concentrations of radioactive material found in the environment). 13) “Rem” means the radiological unit used to describe the radiation dose equivalent to humans, and reflects the absorbed dose in tissue multiplied by the radiation weighting factor specific to the form of radiation to which an individual is exposed. A “rem” is equal to 1,000 “millirem.” The “rem” is also equal to 0.01 Sieverts (the international unit of dose equivalence). 14) “Research-related” means the procedures are not part of the standard of care; i.e., the patients (subjects) would not undergo these procedures if they did not participate in the study. 15) “Results,” as used in the preceding flow chart, means a formal, written memorandum, signed by the Chair of the Medical Center’s Radiation Safety Committee setting forth the conditions of approval or reasons for denial of a protocol involving the administration of radiation to humans.

of 11 16) “Risk language” means the language in both the protocol narrative and the informed consent documents that discusses the magnitude and type of risk associated with the study subject’s exposure to radiation during the course of the study. 17) “RSC” is the acronym for the Radiation Safety Committee at UCIMC. Please refer to the Radiation Safety Committee Review web page at: http://www.research.uci.edu/ora/hrpp/radiationsafetycommittee.htm. 18) “RSO” is the acronym for the Radiation Safety Officer. The Radiation Safety Officer is named on the California Radioactive Materials License, and is responsible for all uses of radiation at the licensed location. UCI’s main campus has a license, as does the UCI Medical Center. 19) “RSSP” is the acronym for the Radiation Safety Subcommittee on Protocols at the Medical Center. The RSSP reviews all protocols required to be submitted to the RSC. The RSSP may approve the protocol, or may refer the protocol to the full RSC under certain conditions (e.g., where the total dose to the maximally exposed patient may exceed 3 rem, or where the protocol involves minors as research subjects). 20) “Standard of Care” means any procedure that a study subject would undergo even if they did not participate in the study. That is, for any clinical study, if the study subjects would undergo all the same types, and the same number of, radiological procedures during the course of their ongoing diagnosis and treatment as they would while participating in the study, then those procedures are “standard of care,” and no review by the RSSP or RSC is required.

of 11 Sample Risk Language for Protocol Narrative and Informed Consent Documents

Below are some examples of risk language that may be used to develop language for the Protocol Narrative and Informed Consent documents related to your research protocol. Please note that these are examples only, and the actual risk language you use must address the specific type and number of research related radiological procedures your study subjects will undergo. You must also provide the radiation dose from each research related procedure, and the total projected dose to the maximally exposed individual (as defined in Item 5 of the preceding “Definitions and Acronyms” section).

The highlighted language in the examples below must be revised to reflect the actual type and number of research related radiological procedures a subject will undergo, as well as the actual radiation dose to which they will be subject, and the correct number of days, months or years of background radiation that is equivalent to that total dose.

PROTOCOL NARRATIVES

EXAMPLE PROTOCOL NARRATIVE RADIATION RISK LANGUAGE for a computed tomography scan:

Subjects will undergo one research related Computed Tomography (CT) scan of the abdomen and pelvis. CT scans use radiation to create pictures of the structures inside the body. The total radiation dose that a subject will receive from one CT scan of this type is about 1 rem. A rem is a unit used to quantify radiation dose. For comparison, persons in the United States receive a radiation dose of about 0.31 rem every year from natural sources of radiation, including from the sun, air, water and soils, so the radiation dose from one CT scan of this type is equivalent to about three extra years of natural background radiation.

There are no known short-term health effects associated with this amount of radiation exposure, and no radiation remains in the body after the scan. The primary risk from radiation exposure at this level is a possible, small increased risk of future cancer.

EXAMPLE PROTOCOL NARRATIVE RADIATION RISK LANGUAGE for a nuclear medicine scan:

Subjects will undergo one research related bone scan using approximately 20 millicuries of technetium-99m Medronate, a drug that is radioactive and used to produce skeletal images. The total radiation dose that a subject will receive from one bone scan is about 400 millirem. A millirem is a unit used to quantify radiation dose. For comparison, persons in the United States receive a radiation dose of about 310 millirem every year from natural sources of radiation, including from the sun, air, water and soils, so the radiation dose from one bone scan is equivalent to a little more than one extra year of natural background radiation.

After the scan, the subject will still have some radioactivity retained in the body, which will go completely away in the following 24 - 48 hours. The risk to others is very low, but the subject may cause sensitive radiation detectors used for security to alarm in the first 1 – 10 hours after the scan. There are no known short-term health effects associated with this amount of radiation exposure. The primary risk from radiation exposure at this level is a possible, small increased risk of future cancer.

[Type text] INFORMED CONSENT

EXAMPLE INFORMED CONSENT RADIATION RISK LANGUAGE for a computed tomography scan:

During this study you will have one Computed Tomography (CT) scan of your abdomen and pelvis. This CT scan is solely for the purpose of this research, and you would not have this CT scan if you decide not to participate in this research study. CT scans use radiation to create pictures of the structures inside the body. The total radiation dose that you will receive from one CT scan of this type is about 1 rem. A rem is a unit used to quantify radiation dose. For comparison, persons in the United States receive a radiation dose of about 0.31 rem every year from natural sources of radiation, including from the sun, air, water and soils, so the radiation dose from one CT scan of this type is equivalent to about three extra years of natural background radiation.

There are no known short-term health effects associated with this amount of radiation exposure, and no radiation remains in the body after the scan. The primary risk from radiation exposure at this level is a possible, small increased risk of future cancer

EXAMPLE INFORMED CONSENT RADIATION RISK LANGUAGE for a nuclear medicine bone scan:

During this study you will have one bone scan using a radioactive drug to produce an image of your bones. The drug is injected in your body, and then after 1 – 3 hours, you will have a scan of your whole body using a “gamma camera” that detects the radiation inside you, and creates a picture of structures inside your body. This bone scan is solely for the purpose of this research, and you would not have this bone scan if you decide not to participate in this research study. The total radiation dose you will receive from one bone scan is about 400 millirem. For comparison, persons in the United States receive a radiation dose of about 310 millirem every year from natural sources of radiation, including from the sun, air, water, and soils, so the radiation exposure from one bone scan is equivalent to a little more than one extra year of natural background radiation.

After the bone scan, you will still have some radioactivity retained in the body, which will go completely away in the following 24 - 48 hours. The risk to others is very low, but you may cause sensitive radiation detectors used for security to alarm in the first 1 – 10 hours after the scan. There are no known short-term health effects associated with this amount of radiation exposure. The primary risk from radiation exposure at this level is a possible, small increased risk of future cancer.

[Type text] Determining Radiation Dose to Human Subjects

When a research protocol involves the exposure of human subjects to radiation, there are a number of issues that must be addressed by the lead researcher in the protocol narrative, and in the informed consent documents. One of these issues is how much radiation dose a subject will receive.

For most imaging procedures involving radiation (e.g., nuclear medicine scans or computed tomography scans) there are no known short-term health or side effects associated with the radiation exposure. The risk associated with these exposures is a theoretical increased risk in future cancer development over the next 20 years. For certain imaging procedures (e.g., those used in interventional radiology and cardiology) there may be a wide range of acute and long-term effects (from mild skin erythema to chronic radiation-induced dermatitis to deep ulcerations requiring skin grafts), as well as the increased risk of a future cancer.

In order to convey the potential risks to a study subject as accurately as possible, it is important to know what each study subject’s radiation dose will be from each procedure involving exposure to radiation. In addition, for nuclear medicine procedures, the protocol narrative should provide the amount of activity (i.e., the millicurie amount of the radiopharmaceutical) that will be administered to the study subject, in addition to the dose that will result from the administration.

There are a number of different ways the dose can be estimated or calculated for various imaging procedures. You may want to discuss the dose estimation with the department that will be performing the imaging procedure, or request information on the dose estimation from the study sponsor. In addition, the references at the bottom of this page are provided. These offer average dose estimation information for a variety of imaging procedures involving radiation.

If the protocol involves a diagnostic or therapeutic administration of unsealed radioactive material, a nuclear medicine physician should be included as a co-researcher in order to supervise the use of the materials, pursuant to California regulations and the terms and conditions of the UCI and UCI Medical Center radioactive materials licenses.

If the protocol involves a therapeutic administration of radiation (from a sealed radioactive source, or machine-produced radiation), a radiation oncologist and medical physicist should be included as co- researchers and consulted regarding all aspects of the treatment planning and dose projections, as well as other aspects associated with the treatment, pursuant to California regulations and the terms and conditions of the UCI and UCI Medical Center radioactive materials licenses.

DOSE ESTIMATION RESOURCES FOR DIAGNOSTIC PROCEDURES:

1) “Effective Doses in Radiology and Diagnostic Nuclear Medicine,” Mettler, et al., Radiology July 2008 Radiology, 248, 254-263 (available at: http://radiology.rsna.org/content/248/1/254.full.pdf). 2) The MSDS and Package Insert resource at the Cardinal Health web-site: http://nps.cardinal.com/MSDSPI/PharmeceuticalItemDisplay.aspx. 3) The American College of Radiology’s table of “Naturally Occurring Background Radiation Exposure,” comparing background dose to common radiological imaging procedures at: http://www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray#part2. 4) The Health Physics Society presents tabulated information on different procedures, compiled from various resources, and posted at: http://www.hps.org/documents/meddiagimaging.pdf. 5) The Conference of Radiation Control Program Directors “Nationwide Evaluation of X-ray Trends” (NEXT) reports, found at: http://www.crcpd.org/NEXT.aspx.

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