TO: COATS Study Coordinators FROM: Kimberly Ring Data Coordinating Center DATE: March 25, 2009 RE: SAE QxQ COATS Coordinating Center Memo #3 This memo addresses the COATS SAE QxQ, which is now available. Please print out the COATS SAE QxQ that follows and insert it into your Study Reference Manual. This document has also been posted to our web site for downloading if necessary. Email confirmation of receipt of this numbered memo is required by each Study Coordinator to the Coordinating Center to Lauren.Eakin@unc.edu. Study Coordinators are responsible to disseminate this information to the appropriate study staff at their sites. J:\COATS\Admin\Numbered Memos\COATSMemo03.doc 3/25/2009
INSTRUCTIONS FOR SERIOUS ADVERSE EVENT FORM SAE, VERSION A (QXQ) I. GENERAL INSTRUCTIONS The Serious Adverse Events Report is completed by the study coordinator or the study physician when the patient experiences a serious adverse event. A SAE can occur anytime between Patient Consent and 30 days after study medication discontinuation. Note: All serious adverse event reports must be signed-off by the study physician. SAEs include AEs that: - Result in death - Are life-threatening - Result in inpatient hospitalization - Prolong an ongoing hospitalization - Are important medical events (e.g., seizures, a malignancy, etc) - Result in persistent and/or significant disability - Result in a congenital anomaly or birth defect - Are overdoses NOTE: For more information on SAE reporting procedures, please see Chapter 12, Section 12.4: Patient Safety and Adverse Event Management, p.51-54 of the Study Reference Manual. General Instructions for Reporting Serious Adverse Events: - Print clearly using a black pen. - Avoid abbreviations. - Where there is a choice of response, please record the appropriate box with an X. - Enter all dates in the format MM/DD/YYYY. - If an error is made, draw a single line through the error, adjacent to the error write the correct entry, then initial and date the correction. - Do not use correction fluid or eraser. Initial Report of a Serious Adverse Event: - For the initial report, you must complete the header information and entire form. Options are available if the information is unknown at this time. - An SAE is not considered reported until it is keyed into the DMS. Once the initial report is complete and the data is entered in the DMS (as SEQ 101), the record will lock in the DMS. CSCC will send an email to the Safety Officer to alert of the SAE initial report. - Print the SAE form from the DMS by right-clicking the cursor anywhere on the screen and selecting yes when asked if you want to print the screen. - Have the study physician/principal investigator sign this printed form. - Fax the form to 888-215-5738 COATS Serious Adverse Event Form, QxQ, SAE, Version A, 03/12/09 Page 1 of 5
Follow-up Report(s) of a Serious Adverse Event: - For follow-up reports, fill out the header information (VISIT, SEQ, Patient Initials and Date) and then only the updated information from the follow-up. The visit is the same visit as the initial SAE but the sequence is the next sequential sequence (102, 103, etc). See Header Information below for more details. - Once the follow-up information is recorded on the form, key the form in the DMS (with SEQ 102 for the first follow-up, SEQ 103 for the second follow-up, etc). Upon keying the Staff Code at the bottom of the form, the form will lock in the DMS. CSCC will send an email to the Safety Officer to alert of the SAE update. - Print the SAE form from the DMS by right-clicking the cursor anywhere on the screen and selecting yes when asked if you want to print the screen. - Have the study physician/principal investigator sign this printed form. - Fax the form to 888-215-5738 Header Information: The header information consists of key fields which uniquely identify each recorded instance of a form. PATIENT ID NUMBER: Affix the pre-printed label to the form. This is a unique 8-character code assigned at the CSCC for each study patient. Labels are provided. FORM CODE: This is a three-letter mnemonic code for the form, which is pre-assigned as SAE. VERSION: This is a one-letter version assigned to the form, which is pre-assigned as A. VISIT: Visit number can be any visit from 01 to 11 and is recorded as the last scheduled visit prior to the event. So if a serious adverse event occurs sometime between visits 07 and 08, then the SAE is recorded with visit 07. SEQ #: This sequential number is used to indicate whether this is an initial report or follow-up information for a previously reported event. For the first SAE, SEQ# is recorded as 101 for the initial report for the participant s first SAE, 102 as the first follow-up, 103 as the 2 nd follow-up, and so on. For the second SAE (in the event there is more than one SAE that occurs at the same visit ), record SEQ# 201 for the initial report, then 202 for the 1 st follow-up, 203 as the 2 nd follow-up, and so on. Note: If the second SAE did not occur at the same visit as the first, then it would have a different visit number, and would start with SEQ# 101, etc. Think of the SAE form as a worksheet - only the new information needs to be filled out on a new form (with the next SEQ number) as it is acquired. Then, only the new information is entered into the data management system (with the same visit number and the next sequence number). PATIENT INITIALS: Enter the first, middle, and last initial of the patient. For those with no middle name, use a (dash). For example: A Z COATS Serious Adverse Event Form, QxQ, SAE, Version A, 03/12/09 Page 2 of 5
DATE: This is the date that the information on the form is completed; ie today s date. Code in numbers using leading zeroes where necessary to fill all boxes. For example, September 6, 2008, would be entered as: 0 9 / 0 6 / 2 0 0 8 M M D D Y Y Y Y II. SPECIFIC INSTRUCTIONS Data Collection Form Information: SECTION A: Serious Adverse Event 1) Record the date of report (MM/DD/YYYY). This is the date that the site was first notified of the event. This date should not change over time. 2) Indicate with an X the Type of Report (either Initial, or Follow-up ). 3) The sex of the subject (either Male or Female ) is populated by DMS. 4) The age of subject in years is populated by DMS. 5) If known, write the Primary Event and/or Diagnosis in the blank provided. Do not exceed the provided space. If the primary event/diagnosis is not known at the time the report is being completed on paper, use the space provided to list the main signs and symptoms. If a new or updated diagnosis subsequently becomes available, then the new or modified diagnosis should be described and recorded on a new SAE form with the next form sequence number. It is not necessary to re-enter existing information from earlier reports in subsequent, follow-up reports (updates in follow-up report[s] will be appended to the initial description that was provided in the initial report). 6) Record Date of SAE Onset (MM/DD/YYYY). Provide the date of onset of signs and symptoms of the event; this date may precede the date on which the event became serious. Partial dates are not acceptable. 7) Date of randomization, when applicable, is populated by DMS. 8) Indicate with an X the appropriate Serious Event Criteria that fits the SAE. More than one criteria may apply, X all criteria that apply; at least one criteria must apply for the serious adverse event form to be applicable. If this information is changed or modified in a follow-up report (new SAE form with next sequential sequence number), indicate all criteria that apply in the follow-up report (by answering the question in its entirety again). 9) If initial or prolonged hospitalization did not occur as a result of the SAE, mark an x in the box for Not Applicable. If initial or prolonged hospitalization did occur as a result of the SAE, indicate whether the hospitalization was due to exacerbation of psychiatric illness. There is also an option for Unknown at this time that can be used when appropriate. 10) In the space provided, write a description of the SAE in chronological order. Do not exceed the provided space. Include any additional information in your description concerning relevant medical history, relevant dates (e.g., hospitalization), signs, symptoms, labs, and relevant treatment. Please be clear and precise in your description as the PSO (Project Safety Officer) will use this description to create a narrative of the event. Additional information discovered after the initial report should be included on a follow-up report by recording the information on a new SAE COATS Serious Adverse Event Form, QxQ, SAE, Version A, 03/12/09 Page 3 of 5
form with subsequent sequence number. The entire description does not need to be rewritten (as we will just append the additions included in the follow-up report to the initial description that was provided). 11) If the SAE was anticipated, record A the box.. If the SAE was not anticipated, please record B in the box. If you do not know, or cannot determine whether the SAE was anticipated or not at this time, record C for unknown at this time. Only one response is allowed. Please refer to section 12.4.8 of the Study Reference Manual for some helpful tips in determining whether or not the event was anticipated. 12) Determine the SAE s relationship to the study antipsychotic (aripiprazole, perphenazine or olanzapine) and record the corresponding letter in the answer box. There is an option for Unknown at this time that can be recorded for the initial report if it is too early to determine the relationship. In this case, the relationship to study medication must be determined at a later time and recorded on paper and in the DMS with a subsequent sequence number. Only one response is allowed. Please refer to section 12.4.8 of the Study Reference Manual for some helpful tips in determining relatedness. 13) Check Yes if the patient was already taking one of the three study antipsychotics prior to randomization and continue on to 13a. Check No otherwise and skip to 14. a. If Yes, record the start date of the antipsychotic. SECTION B: STUDY CONCOMITANT MEDICATION 14) Check Yes if metformin, benztropine or simvastatin was prescribed prior to this event and continue on to 15. Check No if none of these study concomitant medications had been prescribed prior to the event and skip to Item 18. Items 15 [METFORMIN], 16 [BENZTROPINE] and 17 [SIMVASTATIN] on the SAE form collect information on the three COATS study concomitant medications. If the concomitant medication in question had not been prescribed prior to the event, check No and continue to the next section. If the concomitant medication was prescribed prior to the event, then items a through f must be completed. If the relationship, action taken, abatement and/or re-introduction information is unknown at the time of the initial report, then indicate Unknown at this time. In this case, these categorizations must be determined at a later time and recorded on paper and in the DMS with a subsequent sequence number. SECTION C: RESOLUTION AND OUTCOME 18). Record Y for Yes event has been resolved, N for No event has not been resolved, or U for Unknown at this time. If N or U skip to Item 19. If Y answer 18a. 18a. Record date event resolved MM/DD/YYYY. 19) Outcome: Only one response is allowed. All deaths are considered SAEs. If the patient died, record A for Died and answer questions a through d. If the outcome was something other than death, record the appropriate response. If the outcome is unknown at the time of the initial report, then indicate Unknown at this time. In this case, the outcome must be determined at a later time and recorded on paper and in the DMS with a subsequent sequence number. If Death: 19a. Indicate if the death was the result of a suicide. 19b. Record the cause of death 19c. record the date of death MM/DD/YYYY. 19d. Indicate if an autopsy was performed. COATS Serious Adverse Event Form, QxQ, SAE, Version A, 03/12/09 Page 4 of 5
Any changes to responses to questions 19a-d must be made with a follow-up report, by recording this information on a new SAE form with a subsequent sequence number. SECTION D: ACTION TAKEN 20) Action taken regarding study antipsychotic: There are six choices for action taken. A. NONE: this is for patients who were randomized to study antipsychotic, had an SAE but continued their antipsychotic medications with no interruption or dose adjustment. B. DISCONTINUED: this is for patients who were randomized to study antipsychotic, had an SAE and as a result the study physician stopped their study antipsychotic for the duration of the study. C. INTERRUPTED: this is for patients who were randomized to study antipsychotic, had an SAE and as a result the study physician briefly stopped their study antipsychotic but started them back on the study antipsychotic within the acceptable window for keeping them in the study. D. DOSE ADJUSTED: this is for patients who were randomized to study antipsychotic, had and SAE, and as a result the study physician elects to adjust the dose of study medication. E. Not Applicable: this is for patients who had an SAE before randomization into the study. F. Unknown at this time: this is for initial reports in which the action taken with regard to study medication is not yet determined, but will be at a later date. For option A, D, E or F, skip to item 21. For option B or C, record responses to 20a through 20c below. If Discontinued or Interrupted : 20a. Study antipsychotic stop date. 20b. Did event abate after discontinuation/interruption? 20c. Did event reappear after reintroduction? SECTION E: ADMINISTRATIVE INFORMATION 21). Record staff code of person who filled out this form. Data entry instructions for the DMS: For the initial report, first key fields 1 through 20. (NOTE: if some of the information is unknown at the time of the initial report, the form allows for that to be indicated.) Do not key the staff code until all required fields are completed. Skipped fields are not required and DMS populated fields are filled automatically whenever possible. Once all fields are keyed with valid data, then key the staff code. This will lock the form and the Safety Officer will be notified of the event. For follow-up reports, once the updated fields have been keyed, the staff code is entered into the DMS last at which time the form will lock. Upon locking, the Safety Officer will be notified of the update. The principal investigator must sign the printed DMS version of the report. The report is then faxed to the Safety Officer at 888-215-5738. COATS Serious Adverse Event Form, QxQ, SAE, Version A, 03/12/09 Page 5 of 5