B. Permits/Permit Holders

3. Amendments to Radionuclide Use Permits

Amendments to permits are required when a PH wishes to deviate from his/her approved permit. The information required for an amendment varies depending upon the type of amendment desired. All amendments must be signed by the PH (Note: No formal review of an amendment request will commence without this signature.).

Examples of amendments to permits include:

 Generally, the RSO may review and preliminarily approve amendment requests to current permits. Preliminary approval allows the PH to proceed in accordance with the amendment request along with any restrictions mandated by the RSO. Some notable exceptions to the issuance of preliminary approvals by the RSO are as follows:

 For those amendment requests which cannot be preliminarily approved by the RSO, a copy of the amendment request will be distributed to members of the appropriate radiation safety committee. The committee members will have time to review the amendment request and forward any comments to the RSO. Following the initial review, preliminary approval may be granted including any comments and/or restrictions which result from the committee members' review. Preliminary approval of amendments involving in-vivo human use is issued by the chairman of the appropriate committee.

Following preliminary review and approval by the RSO (and, if necessary, by the appropriate committee chairman), the amendment request will be included on the agenda for the next meeting of the appropriate committee with formal review and approval at that meeting. Documentation of formal review and approval of amendments will be maintained in the meeting minutes. It should be noted that the authorized users on a specific permit do not have to be individually approved by a committee except for physicians directly supervising the administration of radioactive material to humans. Once formally approved, a revised permit will be prepared and sent to the PH. In addition, any other committees involved in reviewing amendments to protocols (e.g., IRB) are informed of the radiation safety committee's action.

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This page last modified on Monday April 04, 2005
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