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Reportable Event Application Questions and Guidance

Below is a listing of all the questions asked in the reportable event application. The questions are sorted by screen and many will not be required for your specific reportable event. The guidance links, presented to the right of the questions, will open the guidance window displaying IRB guidance and help on answering the specific question.

1. Project Identification Information
  Title of the Protocol
Principal Investigator
Study Coordinator
Guidance
1.1. Identfier for the Event Guidance
1.2. Submission Type (Select only one) Guidance
1.3. IRBs of record Guidance
2a. Internal Serious Adverse Event
2a.1. Please provide a brief (less than 30 words) summary of the Internal Adverse Event.  Include a description of the AE(s), what was done to treat it, whether the study drug or procedure was interrupted, discontinued, etc. and indicate outcome. Guidance
2a.2. Unexpected/Unanticipated Event (Check all that apply) Guidance
2a.3. Seriousness of the Event (Check all that apply) Guidance
2a.4. Is the event Reasonably Related (Definitely, Probably, or Possibly Related) to the study procedures, drug, or device? Guidance
2a.5. SAE occurring more than 30 days after the subject completes active participation in protocol (Check all that apply) Guidance
2a. Internal Serious Adverse Event
2b.1. Please provide a brief (less than 30 words) summary of the Internal Adverse Event.  Include a description of the AE(s), what was done to treat it, whether the study drug or procedure was interrupted, discontinued, etc. and indicate outcome. Guidance
2b.1.1. Please attach a copy of the safety report or other information from the sponsor or outside agency. Guidance
2b.1.2. Date the report was received by the Investigator. Guidance
2b.2. Unexpected/Unanticipated Event (Check all that apply) Guidance
2b.3. Seriousness of the Event (Check all that apply) Guidance
2b.4. Is the event Reasonably Related (Definitely, Probably, or Possibly Related) to the study procedures, drug, or device? Guidance
2b.5. SAE occurring more than 30 days after the subject completes active participation in protocol (Check all that apply) Guidance
2b.6. In your opinion is the event relevant to the USC/CHLA study population? Guidance
2b.6.1. If no, please provide a brief rationale. Guidance
2c. Non-reportable Adverse Event
2c.1. If the sponsor of the study or the study protocol requires this report to be submitted, or if in your medical/professional judgment you believe that the IRB should review this event, please check here Guidance
3. Type and Date of Event and Current Enrollment
3.1. Please indicate if the event was (check all that apply) Guidance
3.2. Date the event occurred Guidance
3.3. Date Principal Investigator notified Guidance
3.4.1. Number of subjects currently enrolled in the study - USC/CHLA (Integer values only) Guidance
3.4.2. Number of subjects currently enrolled in the study - Study wide, if applicable (Integer values only) Guidance
4. Description of Medical Event
4.1. Choose the descriptor(s) that best describe this event (CTCAE v3.0) Guidance
4.2. Indicate the relationship of the event to the study Guidance
4.3.1. Please provide a narrative description of the following: The adverse event Guidance
4.3.2. Please provide a narrative description of the following: The treatment/intervention provided and the outcome Guidance
5. Description of Psychological, Psychiatric, or Behavioral Event
5.1. Indicate the relationship of the event to the study Guidance
5.2.1. Please provide a narrative description of the following: The adverse event Guidance
5.2.2. Please provide a narrative description of the following: The treatment/intervention provided and the outcome Guidance
6. Description of Event Involving Breach of Confidentiality
6.1.1. Please provide a narrative description of the following: The event Guidance
6.1.2. Please provide a narrative description of the following: The treatment/intervention provided and the outcome Guidance
7. Anticipated Event That Exceed The Severity or Expected Frequency In Protocol
7. Describe how the event exceeded the nature, severity, or expected frequency described in the protocol Guidance
8. Adverse Event Monitoring
8. Please indicate who is monitoring the implications of adverse events (Check all that apply) Guidance
9. Notification and Documentation of Adverse Event
9.1. Please indicate the entities that have been notified of this AE (Check all that apply) Guidance
9.1.1. If Other entity notified, please specify Guidance
9.2. Please attach any additional documentation such as reports received from the sponsor, MedWatch reports or reports sent to other entities regarding this event. Guidance
10. Risk/Benefit Analysis
10.1. In your opinion, is the overall risk-benefit relationship of the research still acceptable in light of this event? Guidance
10.2. Rationale Guidance
11. Protocol/Investigator's Brochure
11.1. Is the possibility of the event listed in the current protocol? Guidance
11.1.1. If yes, copy the description from the current protocol into this section Guidance
11.2. Are protocol changes needed as a result of this event? Guidance
11.2.1. If yes, please briefly indicate the changes here and submit an amendment to modify the protocol. Guidance
11.2.2. If no, please provide the rationale. Guidance
12. Consent Form
12.1. Is the possibility of the event described in the informed consent document? Guidance
12.1.1. If yes, copy the description from the current consent form into this section Guidance
12.2. Are any changes needed in the informed consent document(s) to better inform subjects? Guidance
12.2.1. If yes, please briefly indicate the changes here and submit an amendment to modify the consent form(s). Guidance
12.2.2. If no, please provide the rationale. Guidance
13. Currently Enrolled Subjects
13.1. Do currently enrolled subjects need to be informed of this event? Guidance
13.1.1. If yes, describe the method of notification (e.g., letter, addendum to the consent form, etc.) and submit an amendment for the additional materials. Guidance
13.1.2. If no, provide the rationale for not informing the currently enrolled subjects. Guidance
14. Submission of Data Safety Monitoring Report
14.1. Date the report was received by the Investigator Guidance
14.2. Please attach a copy of the DSMB report Guidance
14.3. Does the information in the DSMB report indicate any increased risks to the subject population? Guidance
14.3.1. If yes, Indicate the actions that will be taken, if any, to protect or inform your research subjects (check all that apply) Guidance
14.3.1.1. If Other, Specify Guidance
15. Protocol Deviation or Error
15.1. Date of the protocol deviation or error Guidance
15.2. Please describe as completely as possible any problems that pertain to the conduct of this study Guidance
15.3. Did the deviation/error result in any increased risk or negative consequences to the subject? Guidance
15.3.1. If yes, please describe and indicate the steps that have been taken to address the issue with the involved subject. Guidance
15.4. Describe the measures that have been taken to reduce the likelihood that similar deviations or errors will occur in the future. Guidance
98. Instructions for Non-Reportable Event Submission
99. Instructions for Reportable Event Submission

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