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GCRC Occurrence Report UTMB

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GCRC Occurrence Report UTMB Powered By Docstoc
					                                 UTMB General Clinical Research Center
                                    OCCURRENCE REPORT
                        Instructions:
                        1. Save this form-file to your desk top (File  Save As)
                        2. Name file according to the following convention:
                                   OR-protocolID_Date.doc (Ex: OR-999_07-15-2007.doc)
                        3. Complete all fields in form.
                        4. Email form by selecting File  Send To  Mail Recipient (As Attachment)

                            Date of Occurrence:                                            (Required fields)

                                     Date of Report:

                   Person Completing Report:
This form is used to capture any event or problem (i.e. – an “occurrence”) that affects the safety of persons
or the quality of a study. Information on this form is to be treated as CONFIDENTIAL.

    If applicable: Unit/Floor "Main: JSH 5th floor" " CH6"                   GCRC Protocol #:

         Principal Investigator:                                                  Subject ID#:
Was this occurrence                                  Yes                No
       an adverse event?
       a protocol deviation?
       an error, omission, or failure that
              resulted in a quality or safety issue?
Check all that apply to the occurrence:
Protocol Implementation                                        Dietary/Nutrition
Scheduling Issue                                               Environmental hazard
Study Procedure or Conduct                                     Loss of Data
Charting/Documentation                                         Data Compromised
Informed Consent/Assent                                        Data Security
Laboratory Tests/Specimens                                     Subject Rights
Equipment/Devices/Supplies                                     Subject Withdrawal
Subject Safety/Welfare                                         Subject Confidentiality
Subject Not Following Protocol                                 Regulatory Compliance Issue
Study Drug or Medication Error
Other:

The occurrence was reported directly to:
   Administrative Manager                          Core Lab Director                   Research Subject Advocate
   Bioinformatics Manager                          IRB                                 Subject Monitor
   Bionutrition Manager                            Nurse Manager                       UTMB Risk Management
   Coordinator, PI, or study staff                 Program Director                    UTMB Legal Department

Other:

When was the occurrence reported?


              Document approved by the GCRC Executive Committee on 5/02/07, approved by the GAC on 5/16/07.
C:\Docstoc\Working\pdf\4a5c20a9-485f-4784-b676-ef8f4de98951.doc          Page 1 of 2Last printed 11/23/2011 10:19:00 PM
                             UTMB General Clinical Research Center                 OCCURRENCE REPORT

Please describe the occurrence in detail:


Please describe any action you have taken in response to this occurrence:


Could this occurrence have been avoided?           Yes           No
If yes, please describe how this occurrence could have been avoided:


Definitions:
Adverse Event (AE)                                                           Protocol *
Any new, untoward sign, symptom or lab test abnormality that                 The plan for a study, including the rationale, background,
develops while a subject is on a study, whether or not you believe it        objectives, recruitment, inclusion/exclusion criteria, laboratory
is related to the study.                                                     requirements, schedule of activities administration of procedures,
                                                                             DSMP, and study analysis methods.
If the occurrence is an AE, check one of the following:
     Anticipated (it is described as a potential risk in the consent         Protocol Deviation*                Yes               No
     form)                                                                   Deviation from IRB-approved activities related to a research
     Unanticipated (it is not described as a potential risk in the           study. This means that an investigator or study team member has
     consent form)                                                           performed activities that are different than those described in the
     Serious (an AE such as death, a life threatening event, or an           protocol, that procedures not previously described in the
     event leading to or prolonging hospitalization, resulting in            protocol were performed, or that procedures described in the
     persisting or significant disability or incapacity, or resulting in a   protocol were not performed.
     congenital anomaly or birth defect.)
*Changes in approved research cannot be initiated without IRB review and approval unless necessary to eliminate apparent
immediate hazards to the subject or provide important information germane to informed consent. The IRB must be notified
immediately per the requirements of 45 CFR 46.103(6)4 and 21 CFR 56.106(a)(3)(4).

     Instructions:
     1. Save form to your desk top (File  Save As)
     2. Name file according to the following convention:
            OR-protocolID_Date.doc (Ex: OR-999_07-15-2007.doc)
     3. Complete all fields in form.
     4. Save changes made to form (File  Save) [Note: Do a Save before sending or changes may be lost.]
     5. Verify file name:
       Click on the line below and hit the F9 key to update: this is the location and name of your report file.
                       Click on the margin (by the arrow) to select the full path and file name.
                       S:\All\Nursing\Forms\GCRC_OccurrenceReportFormFINAL_07.doc
     6. Email form
          Click on link below to create an email message to the reporting group:
                o Don Powell, Karl Anderson, Lori Wiseman, Victoria Korschgen, Astrid Inniss, Michele
                    Carter, Melinda Moore
          Add this file as an Attachment (Save and Close the file) and Send the email.
                o Click on the Insert File       icon in your email message and paste the file path and name
                    information from step 5 in the File Name box.


                   Please email Michele Carter with any questions or comments or call 409-772-1208.




                  Document approved by the GCRC Executive Committee on 5/02/07, approved by the GAC on 5/16/07.
C:\Docstoc\Working\pdf\4a5c20a9-485f-4784-b676-ef8f4de98951.doc                        Page 2 of 2Last printed 11/23/2011 10:19:00 PM

				
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