How can I enter ER/LA Opioid Analgesics REMS activity data in PARS?

Published Date: 
October 29, 2013

At the bottom of the Add an Activity screen, you will see a section called Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS). Follow the instructions to enter data about REMS-compliant and REMS-related activities.

If you are implementing an an ER/LA Opioid REMS activity that is commercially supported by the REMS Program Companies (RPC)/Campbell Alliance, Ltd., you can fulfill the activity data reporting requirements of your commercial support agreement by completing the questions in this section of PARS. You may also choose to complete this section if your activity addresses the ER/LA Opioid REMS but it is funded by a commercial supporter other than the RPC/Campbell Alliance, Ltd. or it does not receive any commercial support. If this is not an ER/LA Opioid REMS activity, then you do not need to complete the questions in the section.

Accredited providers can enter data specific to REMS activities only by using the web-based interface. PARS does not currently have the functionality to allow REMS-specific data to be batch-uploaded via the tab-delimited or XML upload features. However, you can batch upload REMS activities, without including the REMS-specific data, by using the tab-delimited or XML batch upload formats. You can then add the REMS-specific data by visiting the View Activities screen in PARS and clicking the edit button next to the activity for which you would like to add data.

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