SAE resporting for case 005
Download as PPTX, PDF1 like919 views
The document discusses adverse event and serious adverse event reporting in clinical trials. It provides definitions for key terms like adverse event, serious adverse event, and unexpected adverse reaction. It outlines ICH-GCP guidelines for safety reporting, including immediate reporting of SAEs to sponsors. Finally, it presents a case study describing a subject's experience of accelerated hypertension as an SAE during a clinical trial and the appropriate reporting steps taken.
SAE resporting for case 005
- 1. ADVERSE EVENT/ SERIOUS ADVERSE EVENT REPORTING IN CLINICAL TRIALS Ashish Singh parihar
- 2. OVERVIEW Important Terms and Their Definitions ICH-GCP Guidelines for AE/SAE Reporting Case
- 3. Terms And Their Definitions Adverse Event Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. An AE may be expected or unexpected, related or unrelated to the subject’s participation in the research, local or non-local, and serious or not serious. The study investigator is responsible for determining the status of an event.
- 4. Conti… Adverse Reaction (AR) Any untoward and unintended responses to an investigational medicinal product related to any dose administered Unexpected Adverse Reaction (UAR) An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator’s brochure for an unauthorized investigational product or summary of product characteristics for an authorized product)
- 5. Conti….. Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) or Suspected Unexpected Serious Adverse Reaction (SUSAR) Any AE, AR or UAR that at any dose: ◦ results in death ◦ is life-threatening* ◦ requires hospitalization or prolongation of existing hospitalization ◦ results in persistent or significant disability or incapacity ◦ consists of a congenital anomaly or birth defect
- 6. Common Terminology Criteria for Adverse Events v3.0 (CTCAE SAE/AE will be assessed as per the following grades Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE
- 7. ICH-GCP Guidelines for Safety Reporting All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.
- 8. Conti…. 4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol. 4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports)
- 9. Notification guidelines Regulation 32 sets out the following responsibilities for the notification of adverse events to sponsors: 1. An investigator shall report any SAE that occurs in a subject at a trial site immediately* to the sponsor (unless covered by point 2 below). This immediate report may be made either orally or in writing as long as detailed written report follows the immediate report. 2. The sponsor may specify in the protocol certain SAEs that an investigator does not have to report immediately. The protocol should state how and when these events should be reported.
- 10. Appendix XI Template Data Elements of AE/SAE should be filled in Appendix XI form and submitted
- 12. Case Details The Subject was Screened on 25/mar/2014 and he underwent placebo Run-in and Lipid stabilization on 25/mar/2014 & he is still in screening period. The subject experienced left sided chest pain which was non-radiating and not associated with sweating on 9/Apr/2014 at 8.30 and he went to a local hospital where ECG and other physical examination were done. Upon examination the subjects BP was found to be 150/100mm/Hg and his ECG showed possibilities of IMWI( Inferior Wall Myocardial Infraction).
- 13. Conti…. He was given the following medications Tablet Asprin 300mg Stat Tablet Clopidogrel 600mg Stat Tablet Atorvastatin 80mg Stat Tablet Isosorbide Dinitrate 5mg Stat Tablet Metoprolol 25mg Stat The subject called to the site at 13:00 and he was asked to come to the hospital immediately
- 14. Conti… ..as per PI’s discretion. He came to the site at 17:25. he was examined by the PI who advised the patient to get admitted to medicine department for further treatment and consultation under the PI’s observation. After considering the lab results and symptoms , subject was diagnosed of Accelerated Hypertension
- 15. Conti… After 4 days of hospitalization the subject got discharged since he has shown improvement. Discharge Medications • Tablet Isosorbide Mononitrate 30mg OD • Tablet Metmorfin 500mg OD • Tablet Ramipril 2.5mg OD • Tablet Metoprolol 25mg OD • Tablet Aspirin 75mg OD
- 16. Risk Assessment Assessment was done by PI to check whether it was SAE/AE. • The subject got hospitalized as per PI’s discretion therefore this is termed/considered as an Adverse Event (As per Drug and Cosmetic act definition). • On assessment PI found that the SAE was not related to Study drug so any action was not taken on the study drug.
- 17. Conti… According to the standard grading system the SAE was graded as GRADE 3 – Severe (Require Hospitalization) Appendix XI form As per the guidelines the Appendix XI form was filled for reporting of SAE
- 18. SAE Reporting – Appendix XI Appendix XI details Details in Appendix XI were filled as follows 1. Patient Details • Initials and other relevent identifier – KMS, IP 524002 • Gender – Male • Age and DOB – 52 years, DOB-08/JAN/1962 • Weight - 58kgs • Height – 170cm
- 19. Conti… 2. Suspected Drug : SAE not related to the IP • Generic name of the drug – blinded ADT 124 • Indication for which suspect drug was prescribed – dyslipidemia • Dosage form and strength – Auto-Injector 140 mg/ml • Daily dose and regimen – Blinded information • Route of Administration – IV • Starting Date and Time of day – NA (Subject was still undergoing screening)
- 20. Other Treatments.. 3. Other Treatments – provide same information for concomitant drugs Generic name Indication s for drug was prescribd Dosage Form and strength Daily dose and regimen Route of administr ation Starting date and time of day Stopping Date and time Isosorbide Mononitrat e Chest Pain 30mg OD Oral 9/APR/14 Cont. Metformin Diabetes Mellitus 500mg OD Oral 9/APR/14 Cont. Asprin Myocardia l Infraction 75mg OD Oral 9/APR/14 Cont. Ramipril Hypertensi on 1.25mg OD Oral 9/APR/14 Cont. Metaprolol Hypertensi on 25mg OD Oral 9/APR/14 Cont.
- 21. Appendix XI 4. Details of Suspected Adverse event were written in detailed manner (as per patient details in previous slides), full description of reaction including body site and severity, as well as the criterion for regarding the report as serious . In addition to a description of the reported signs and symptoms, diagnoses for the reaction were written in a detailed form. Medications prescribed and details of hospitalization were mentioned.
- 22. Conti… Start date of onset of reaction – 9/Apr/14 Stop date or duration of reaction – 12/Apr/14 Setting – Hospital 5. Outcome – Resolved 6. Details of the Investigator, name, Phn no, profession, address were mentioned. Date of reporting – 18/Apr/14 Date of reporting to EC – 18/Apr/14 and investigator signed the form
- 23. Safety Reporting After the phone call from the subject PI assessed the event as SAE and reported it to the members of sponsors/CRO by mail. PI prepared a Submission letter for SAE , filled the details of appendix XI form, CIOMS form, filled and updated the event in e-CRF and in CRF Submission letter and covering letter was submitted to EC and DCGI for reporting the SAE on 10th April 2014 i.e. next day of the event( as per guidelines and regulatory requirements)
- 24. Conti… EC and DCGI reviewed the SAE report and acknowledged it and sent a Receipt . After the discharge of subject from the hospital PI prepared a follow up report and submitted it to EC and DCGI. Outcome - SAE was resolved as the subject recovered from Accelerated Hypertension
- 25. Conti… All the forms, acknowledgments, lab reports, Letters and other documents were filed in patient file for further monitoring and audits. Subject was randomized and he continued his participation in the study