EAP Request Form - Draft

EAP Request Form - Draft

<p> Corbus Expanded Access Program Physician Request Form Download and Save:  Before you begin completing the request form, save the EAP Request Form to your computer by selecting “Save As.” </p><p> The File type should be Word.document, then click “Save.” Once the file is saved, please complete the form</p><p>Completion Instructions:  Please complete the Expanded Access Program (EAP) fields below to submit a request for expanded access (compassionate use) of a Corbus investigational product.  Please do not handwrite the information in this form.  Do not include the patient’s name or submit any patient-identifying information.  Any fields marked with a red asterisk (*) are mandatory. Submission Instructions:  Upon completion of the request, please submit form as an e-mail attachment to: [Insert email address]  Please include the name of the drug for which this request is being submitted in the subject line of your e-mail. Decisions about providing drug will be made solely by Corbus in accordance with its policies and procedures. Corbus’s acceptance and processing of this application does not guarantee that access to investigational product will be provided.</p><p>Page 1 of 4 Form created 3/9/2017 9:26:15 AM Corbus Expanded Access Program Physician Request Form</p><p>*Date of Request (DD/MMM/YYYY): Click here to enter a date. *Corbus Drug Name: * Health Care Professional (HCP) Name: <enter first and last name> Title: <enter HCP Title> * HCP Address: <enter address line 1> <enter address line 2> <insert city, state/province> <insert postal/zip code> <insert country> * HCP City, State/Province: * HCP Postal Code/Zip Code: * HCP Country: *HCP Telephone Number: HCP Mobile Number: *HCP E-mail Address: Organization/Institution Name: <enter organization/institution name> Organization/Institution Address: <enter address line 1> <enter address line 2> <insert city, state/province> <insert postal/zip code> <insert country> Corbus Contact, if any <enter first and last name> Patient Information *Patient Initials/Identifier (limit of 3 characters): -- * Disease/Indication to be Treated: * Date of Diagnosis (MM/YYYY, if known): MM/YYYY *Age of Patient (Years): Patient Month/Year of Birth (MM/YYYY): MM/YYYY *Gender of Patient: Choose an item. Weight of Patient (kg): Height of Patient (cm):</p><p>*Provide patient medical history/current physical condition/ rationale for request (including a detailed summary of disease): </p><p>*Patient Medications List patient's current drug treatment(s), concomitant medication(s) and outcome (if applicable) for the disease or condition for which this request is being made: </p><p>☐ Not Applicable- No current treatment</p><p>Current Medications:</p><p>Page 2 of 4 Form created 3/9/2017 9:26:15 AM Corbus Expanded Access Program Physician Request Form</p><p>*Proposed Treatment Plan Dose Route Planned Duration Comments</p><p>Insert Monitoring Procedures and Modifications to Dose (optional): *Treatment is planned Choose an item. to continue as long as the patient continues to experience benefit and tolerates therapy. *Treatment will be Choose an item. administered in a facility with prior experience handling investigational products, and by a physician with prior clinical trial experience. *There are no other Choose an item. comparable or satisfactory alternative therapies to treat the patient’s disease or condition and/or all currently available therapies have been exhausted. *Please provide rationale for why the patient would not be a good candidate for available therapies that have not previously been used: *Please provide rationale for why the patient cannot participate in a clinical trial: *There is nothing Choose an item. unique about this patient which suggests that a clinically meaningful benefit from the proposed treatment plan would not be Page 3 of 4 Form created 3/9/2017 9:26:15 AM Corbus Expanded Access Program Physician Request Form expected. *There is nothing Choose an item. unique about this patient which suggests that there would be an unreasonable risk posed by the proposed treatment plan. Comments</p><p>Please utilize this space to provide any additional comments regarding this expanded access request (optional): </p><p>Page 4 of 4 Form created 3/9/2017 9:26:15 AM</p>

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