DFCI IRB ADVERSE EVENT REPORTING FORM

Transcription

1 Office for Human Research Studies DANA-FARBER / HARVARD CANCER CENTER DFCI Protocol No.: OHRS USE ONLY HRC: AE #: (unless submitted with an Amendment) Related AM #: DFCI IRB ADVERSE EVENT REPORTING FORM Instructions: This form is for the reporting of adverse events experienced by either (1) local DF/HCC participants or (2) outside Multi-Center Site participants where a DF/HCC investigator is the overall PI. All other adverse events must be reported via IND Safety Reporting mechanism. Please refer to the DFCI IRB policy on reporting AEs to determine which AEs should be reported to the IRB. This form must be submitted as an attachment to an Amendment Form if any protocol and/or consent form changes are required as a result of this reported event. All AEs must be reported via OHRS Submit. No interoffice submissions, faxes or ed reports will be accepted. If this is a report of an event from a multi-center site and a local form is available, please complete Part A, B and Part I, J and attach the local form with this form and submit them both via OHRS submit. Investigators are responsible for knowing the reporting requirement to their institutional risk management department. Please make sure that any reported adverse events, if appropriate, have also been reported to the applicable risk management group. Please call the OHRS with any questions at (617) Part A Study Information Disease Program: Leukemia -OR- Discipline Program: [pull down] [Refer to Protocol Front Sheet for study Disease or Discipline Program name] Protocol Short Title: DFCI ALL Consortium Adult ALL Trial Today s Date: 1/2/2013 Overall Principal Investigator (PI): Daniel DeAngelo, MD, PhD [First Name, Middle Initial, Last Name, Degree(s)] Phone: Pager: Institution: DFCI [PI Institution] Part B Report and Site Information 1. Report Type [Initial, Follow Up 1, Follow Up 2, Follow Up 3]: Initial 2. Date Reported to OHRS: Was this AE reported within the required reporting time period? Yes No - If this Adverse Event (AE) Report was submitted outside of the required reporting time period please explain why and include an appropriate corrective action plan below. Do not file a separate violation. Corrective Action Plan for Delayed Reporting: 3. Reporting Investigator Name: Martha Wadleigh, MD Institution: DFCI [First Name, Middle Initial, Last Name, Degree(s)] Mwadleigh@partners.org Phone: Pager: Site Involved in this Event: DFCI If this site is not participating under the DFCI IRB, please respond to the following question: Is this an outside site participating in a trial where a DF/HCC investigator is the overall PI? Y If yes, you do not have to complete Part C thorough Part H if you attach as supplemental information the local reporting form. Adverse Event Reporting Form Version:

2 N If no, do not complete this form. Please submit your IND/IDE Safety Report to the DFCI IRB as an amendment but only if it meets the OHRS reporting requirements outlined in the DFCI IRB Policy on Receipt and Review of IND/IDE Safety Reports. 5. Name of Study Contact for questions about this submission: Caroline Kokulis Role on Study: Coordinator Institution: DFCI Phone: Pager: Part C Participant Information 1. Participant Study I.D. Number and/or Initials: AY: Date of Serious Adverse Event: 12/28/12 3. Participant Age: Participant Gender: Female 5. Condition Studied: ALL Part D Drugs / Biologics N/A Drug/Biologic Dose Route Schedule FDA IND # and IND Holder Date of First Dose Date of Last Dose (prior to AE) Vincristine 2 mg Intravenous Day 1 N/A 12/7/12 12/7/12 6-MP 50 Oral Days 1-14 N/A 12/7/12 12/20/12 mg/m2/day Dexamethasone 6 Oral Days 1-5 N/A 12/7/12 12/11/12 mg/m2/day BID Methotrexate. 30 mg/m2 Intravenous Day 1 N/A 12/7/12 12/7/12 IT MAH 12 mg, 40 mg, 50 mg Intrathecal Every 18 weeks N/A 10/26/12 10/26/12 Part E Devices N/A Device Name Humanitarian Device? Y N Y N Manufacturer Type of Device FDA IDE # and IDE Holder Date of Procedure Part B Gene: Vector Type: Vector Subtype: Part F Human Gene Transfer Studies Only N/A - 2 -

3 Delivery Method: Dose: Route: Schedule: Date of First Dose: Date of Last Dose: If Other, please specify: - 3 -

4 Part G Descriptive Adverse Event Information Event Description: This patient is a 23 year old female who is enrolled on the trial to treat her Acute Lymphoblastic Leukemia. She is currently in Continuation phase of the study. She was admitted 12/28/12 to BWH with fevers, a non-productive cough, and a green nasal discharged.the patient stated that she had fevers, night sweats, chills, nausea on 12/24/12. Her fever was on 12/27/12. The chest x-ray showed diffuse groundglass opacities bilaterally in the lung bases. She was started on Bactrim PO. This indicated atypical pneumonia, most likely pneumocystis pneumonia. All chemotherapy is being held for at least one week. The patient states that she has been compliant with her Mepron medication. She was treated with steriods and Bactrim, and improved. She was discharged from the hospital on 1/1/13 and will be seen at DFCI on 1/4/13 for follow up. Co-morbidity/Past Medical History: The participant was hospitalized or hospitalization was prolonged. The participant was taking concomitant medications. Medication name(s): Outcome: Still under treatment for event (include date) Date: 12/31/12 Protocol Treatment: Treatment was altered Date: 12/31/12 Part H Adverse Event(s) Please indicate what NCI toxicity version is being used to grade toxicities: CTCAE Version 3.0 For more information please refer to: Adverse Event Event Date Grade (2-5)* Pneumocystis pneumonia Related to Study Treatment? Event Related to Underlying Disease? 12/28/12 3- Severe Definite No Expected/ Unexpected/ Not Applicable [with respect to study treatment] Expected This adverse event is already included in the current consent form(s). Specify the page number(s): Consent pg:

5 No This adverse event is already included in the current consent form(s). Specify the page number(s): No This adverse event is already included in the current consent form(s). Specify the page number(s): No This adverse event is already included in the current consent form(s). Specify the page number(s): Part I Protocol Revisions / Participant Notification 1. Will currently enrolled participants be notified of this adverse event? Y N Explanation: This kind of infection is expected with this study treatment regimen. 2. Are any protocol and/or consent form changes being proposed as a result of this adverse event report: - 5 -

6 Yes. This AE is being reported as an attachment to an Amendment Form submission because protocol and/or consent form changes have been made. No. No changes to the protocol and/or consent form document are required as a result of this report. Part J Statement of Reporting Investigator Form completed by: Name: Caroline Kokulis Role on Study: Coordinator Date: 1/2/2013 Phone: Ckokulis@partners.org The Reporting Investigator assures that the information provided in this submission is complete and accurate. The Overall Principal Investigator (PI name: Daniel DeAngelo, MD, PhD ) has been notified of this event on (date:12/28/12 ). Name of Reporting Investigator: Dr. Martha Wadleigh, MD All Adverse Events reported to the Office for Human Research Studies will be reviewed by an IRB member via an electronic workflow. The electronic workflow will document any expedited review determinations