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Download eGFR-C Serious Adverse Event Form v1.0
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ISRCTN42955626 Confidential once completed Please answer all the questions eGFR-C – SERIOUS ADVERSE EVENT (SAE) FORM Please report immediately any SERIOUS ADVERSE EVENTS (see eGFR-C Protocol, Section 9 for definition) occurring within 24 hours of iohexol administration, by completing all of the details below and faxing this form to the eGFR-C Trial Office on 0121 415 9135. Please also complete the SAE form if the patient dies. eGFR-C Study Number: Responsible study clinician: Patient sex: Mi iMi Mi / Yii iYii iYii iYii ii ii Male ii ii Female Current Patient Height (cm): Is this report: Date of Birth: Hospital Name: ii I ii I ii I ii ii I ii Current Patient Weight (kg): I i ii ii ii ii . ii ii Initial Report Seriousness of event (please provide a response to each question) Death Yes Follow-up Report No Ii ii I i ii ii . ii ii Final Report Details If Yes, date of death iDi iDi / Mi iMi iMi / Yii iYii iYii iYii Category of death: …………… (1 – Cancer, 2 – Cardiovascular, 3 – Cerebrovascular, 4 – Renal, 5 – Hepatic, 6 – Respiratory, 7 – Neurodegenerative, 8 – Accidental (death not caused by disease), 9 – Other) Cause of death: ………………………………………………………………………………………. Life threatening event In-patient hospitalisation or prolongation of existing hospitalisation If Yes, Initial Prolonged If Yes, number of days spent in hospital as result of the SAE Persistent or significant disability/incapacity Congenital abnormality or birth defect Other pertinent medical reason for reporting? If Yes, please specify: ……………………………………………………………………… ………………………………………………………………………………………………………………………….. ………………………………………………………………………………………………………………………….. Date Event Started CTCAE category iDi iDi / Mi iMi iMi / Yii iYii iYii iYii I i i Please refer to coded list on Page 4 Serious adverse event description: include a) diagnosis, b) changes in medications, c) relevant investigation results, d) treatment of the SAE, e) location. (Please answer all points a-e and attach copies of relevant reports). ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….... ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….... ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….... ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….... PTO When you have faxed the form, please then send this form (with copies of any relevant reports) to the eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT. eGFR-C SAE Form Page 1 of 4 Version 1.0 14th Feb 2014 ISRCTN42955626 Confidential once completed Please answer all the questions Details of relevant medical history (indicate if medical history is considered ‘nil relevant’) ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. Iohexol administration causality assessment The assessment of causality must be provided by a clinician Date of iohexol administration Causality Assessment Action taken due to SAE 1 Unrelated to iohexol administration 2 Unlikely to be related to iohexol administration 3 Possibly related to iohexol administration 4 Probably related to iohexol administration 5 Definitely related to iohexol administration 1 Iohexol administration discontinued – no iohexol to be administered in the future 2 Considered safe to administer further iohexol in the future 3 Unknown 4 N/A DD / MMM / YYYY I i I i Please give reasons why you consider the event to be related to the iohexol administration ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….... ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….... Did iohexol administration cause an anaphylactoid reaction? Yes If Yes, what treatment was the patient given? Antihistamine Corticosteroid Adrenaline Other No N/A if Other please specify: ……………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. Was the SAE unexpected, i.e. of a type or severity which is NOT consistent with the up-to-date product information? This section must be completed by a clinician. Unexpected Expected Unrelated If Unexpected, please give reasons why you consider the event to be unexpected: ………………………………………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. Concomitant Medication Please provide details of other medication the patient was taking prior to the event: Drug Name (give generic name) Start date Tick if continuing or specify stop date Dose Unit Frequency Route Indication Please refer to coded list on Page 4 _______________ __ _______________ __ _______________ __ _______________ __ _______________ __ _______________ __ DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY DD / MMM / YYYY PTO When you have faxed the form, please then send this form (with copies of any relevant reports) to the eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT. eGFR-C SAE Form Page 2 of 4 Version 1.0 14th Feb 2014 ISRCTN42955626 Confidential once completed Please answer all the questions What was the final outcome of the event? Resolved no sequelae If Resolved, date of resolution: iDi iDi / Mi iMi iMi / Yii iYii iYii iYii Resolved with sequelae If Resolved, date of resolution: iDi iDi / Mi iMi iMi / Yii iYii iYii iYii Specific sequelae: ………………………………………………………………………………………………………………………………………….... ................................................................................................................................................................................................. Continuing Fatal If Continuing, please provide date of resolution on follow-up/final SAE form Details of person reporting: Signature of Person Reporting (you must be listed on the site delegation log): Name of Person Reporting: Position: Telephone Number: Email Address: Fax Number: Date of reporting: iDi iDi / Mi iMi iMi / Yii iYii iY i iYii Signature of Principal Investigator (if not reported by PI): SUSAR Reporting For BCTU use only Date reported to BCTU? iDi iDi / Mi iMi iMi / Yii iYii iY i iYii Date reported to CI? Date reply received from CI? iDi iDi / Mi iMi iMi / Yii iYii iY i iYii iDi iDi / Mi iMi iMi / Yii iYii iY i iYii Is this event a SUSAR? No Is this a SAE? Yes No 7 day report OR Yes 15 day report CI comments: …………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….. CI signature: Date: iDi iDi / Mi iMi iMi / Yii iYii iY i iYii Due to be reported to Ethics Committee Date: iDi iDi / Mi iMi iMi / Yii iYii iY i iYii PTO for Coded Reference Lists When you have faxed the form, please then send this form (with copies of any relevant reports) to the eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT. eGFR-C SAE Form Page 3 of 4 Version 1.0 14th Feb 2014 ISRCTN42955626 Confidential once completed Please answer all the questions Coded Reference Lists Common Terminology Criteria for Adverse Events v3.0 (CTCAE Coded List) Code Category Code Category 1 Allergy/Immunology 15 Infection 2 Auditory/Ear 16 Lymphatics 3 Blood/Bone Marrow 17 Metabolic/Laboratory 4 Cardiac Arrhythmia 18 Musculoskeletal/Soft Tissue 5 Cardiac General 19 Neurology 6 Coagulation 20 Ocular/Visual 7 Constitutional Symptoms 21 Pain 8 Death 22 Pulmonary/Upper Respiratory 9 Dermatology/Skin 23 Renal/Genitourinary 10 Endocrine 24 Secondary Malignancy 11 Gastrointestinal 25 Sexual/Reproductive Function 12 Growth And Development 26 Surgery/Intra-Operative Injury 13 Hemorrhage/Bleeding 27 Syndromes 14 Hepatobiliary/Pancreas 28 Vascular Concomitant Medication Codes (Units, Route, Frequency) Unit Codes Route Code 1 mg 1 Intra-arterial 2 µg 2 Intraperitoneal 3 g 3 Intravenous 4 puffs 4 Oral 5 units 5 Respiratory (inhalation) 6 ml 6 Subcutaneous 7 mg/ml 7 Topical 8 mg/kg 8 Suppository 9 µg/ml 9 Intra-occular 10 AUC 10 Intramuscular 97 Other, specify 97 Other, specify 99 Not known 99 Not known Frequency Code 1 Twice a day 2 Three times a day 3 Four times a day 4 Hourly 5 4 hourly 6 Daily 7 Alternate days 8 As desired 9 If necessary 10 Slow release 97 Other, specify 99 Not known eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT Tel: 0121 415 9130 Fax: 0121 415 9135 eGFR-C Study Website: http://www.birmingham.ac.uk/egfrc eGFR-C Study Mailbox: [email protected] When you have faxed the form, please then send this form (with copies of any relevant reports) to the eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT. eGFR-C SAE Form Page 4 of 4 Version 1.0 14th Feb 2014
