How to report an SAE

1. HOW TO REPORT A SERIOUS ADVERSE EVENT Dr. Shweta Bhatia M.Sc. CR Anovus Institute of Clinical Research 1

2. OBJECTIVES SAE reporting timelines Familiarizing with the Checklist Documents to be submitted Adequacy of the documents Responsibilities of the stake holders 2

3. Serious Adverse Event : Definition An SAE or SAR is any untoward medical occurrence that: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant Disability/incapacity Is a congenital anomaly/birth defect Is of medical importance 3

4. SAE REPORTING – PROCESS AND TIMELINES 4 GSR 53 E dated 30 Jan 2013

5. SAE Occurrence Initial Report Within 24 hours of SAE occurrence Investigator DCGI Chairman EC Sponsor/CRO Within 10 Calendar Days of SAE occurrence Analyzed Report Head of Institution Chairman of EC DCGI Within 21 Calendar Days of SAE occurrence Analyzed Report & Compensation recommendation DCGI Within 30 days of Receiving report From EC Recommendation on Compensation Sponsor/CRO Patient/Relative Within 3 months of Receipt of SAE report Order for Compensation Within 30 days of Order of receipt Final Compensation to be paid Chairman of Expert Committee (DCGI) Chairman of Expert Committee (DCGI) In case of Death 5

6. SAE Reporting Requirement Time lines.. The timelines discussed is the maximum time limit to send the information but the information should be send as early as possible Clear and unequivocal information should be provided in the SAE report. Keep adequate margins in the Left hand side The documents printed on both sides of a page, can be submitted. However, one should take care that the information is not obscured when the page is placed in a binder. 6

7. Reporting of SAEs PI/Designee will report the SAE to (in the SAE form) DCGI [email protected] Sponsor EC chairman Please note to use the site letter head wherever required 7

8. How to report? … completing the Index page 8 Include a cover page with every report (Initial/follow ups). Please ensure that all listed documents are enclosed The SSE to assist the Investigator to prepare the SAE reports for Submission to CDSCO as per Appendix XI of Schedule-Y The set of documents as per the checklist to be arranged with proper indexing and page number

9. 1. Completed Checklist page 1 9 All items mentioned in the checklist may not be applicable for all SAEs . The items not relevant to a particular SAE should be marked “Not Applicable (NA)”.

10. Completed Checklist page 2 10

11. 2. Covering letter to the DCGI 11

12. ADEQUACY IN COMPLETING THE DOCUMENTS 3. Appendix XI Check for the completeness and correctness SAE form should be filled only from the source Review Source, eCRF entry & Protocol before completion Subject Details Suspected Drug Concomitant Drug History Details of the Event Outcome Signed and Dated by the Investigator 12

13. Narrating the Event Full description of the event (s) Body site Severity, criterion (or criteria ) for regarding the report as serious. description of the reported signs and symptoms, Describe a specific diagnosis for the reaction Event term may change during the follow up period Outcome: Follow up till resolution. All follow up reports to be notified to EC & Sponsor 13

14. Causality Assessment SSE to provide all documents to the PI to make the right assessment with reasoning for Related/Unrelated/Possible/Probable . Source notes before/during/after the Event Relevant documents from other hospital (if applicable). 14

15. Analysis of SAE The analyzed report should contain following information: Diagnosis/ ConMed information if any. Whether the SAE was severe/moderate/mild SAE falls under which criteria of seriousness as per SAE definition Whether the adverse events was serious and suspected or serious and unexpected Causality assessment i.e. related to the study drug or not What action was taken with the study drug i.e. continued or discontinued or interrupted for certain duration Whether the dose of the study drug was increased or decreased or continued as previous dose Outcome of SAE i.e. resolved/not resolved/resolved with sequelae If SAE related to death/if Autopsy is performed -detailed Autopsy report. 15

16. Common Errors Observed .. Date of Birth discrepancy in the discharge summary/lab report/Autopsy report etc. Units not mentioned for Height, Weight etc Writing the signs & Symptoms instead of mentioning the Event name (e.g. abdominal pain instead of appendicitis) If the severity of the baseline illness/lab abnormality later developed into an SAE, mismatch noticed in the start and stop dates of AE & SAE Subject’s confidential information are not masked in the lab report/discharge summary etc Discrepancy in the start date/stop date entry of Concomitant medication and AE/SAE start/stop date Date and signature of the delegated person not present in the Lab reports Resolve the queries with adequate explanation, to avoid re-queries 16

17. Adequacy of Documents contd.. 4 . Lab reports/Discharge summary Include lab reports showing baseline values of Investigations prior to administration of IP & during the time of SAE (as required) Mask the subject identifiers (name, MRD/OP/IP no:, address etc ) Ensure that PI/Sub I has reviewed the reports by confirming the date and signature 5 . Additional Information Protocol Title/Study No/Code CTRI Registration No Sponsor/CRO details Details about the Ethics Committee Site No:, Site Address Socio economic background of the subject viz qualification, Occupation, monthly income 17

18. Additional Information 18

19. 6. EC Notification 19 SSE to ensure the initial reporting has happened within 24 hours of occurrence of the event. Confirm the date of submission and date of acknowledgement mentioned in the Notification letter

20. Documents Required.. 7. DCGI Approval Letter 8.Signed ICF Mask the subject identifiers except signatures (name , address, name of the nominee address etc.) 9. English version of the ICF to be enclosed in case local language ICF is used 10. eCRF pages Relevant eCRF pages where the details of the SAE are captured 20

21. SAE Reporting by Sponsor/CRO Upon receiving initial SAE report from Investigator, Sponsor will perform analysis in consultation with PI Sponsor/ CRO will transform this information in CIOMS Form and will submit this analyzed report within 10 calendar days to DCGI, Chairman of EC and Head of Institution where study is being conducted. 21

22. SAE Reporting by Ethics Committee The reports of SAEs of deaths should be prepared and submitted in Red Cover. The reports of SAE of injury other than deaths should be prepared and submitted in Blue Cover The SAE report other than death or injury is to be prepared and submitted in White Cover . cover 22

23. References www.cdsco.nic.in http://cdsco.nic.in/writereaddata/procedure%20for%20prescreening%20and%20checklist%20_final%20on%2022-04-2014.pdf System of Pre-screening for submission of reports of SAEs for CDSCO 23

24. Thank You 24