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Download Adverse Event Record - Global Health Trials
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Protocol Centre Number Patient Number Patient Initials Non-serious Adverse Experiences xxxx/xx ADVERSE EXPERIENCES Page ..... Record any adverse experiences (using medical terminology) observed or elicited by the following direct question to the patient’s parent or guardian: “Has your child appeared different in any way since starting treatment or since the last visit?” Provide the diagnosis not symptoms where possible. One adverse experience per column. If no adverse experiences please mark this box and sign the form below. Adverse experience. (please print clearly) 1. 2. Onset Date and Time. End Date and Time. (If ongoing please leave blank) Outcome. If patient died please inform sponsor within 24 hrs and complete Form D. Day Month Year 24 Hr:min Day Month Year 24 Hr:min Day Month Year 24 Hr:min Day Month Year 24 Hr:min Resolved Ongoing Died Intermittent Experience course. Intensity (maximum). Action Taken with Respect to Investigational Drug. Relationship to Investigational Drug. Resolved Ongoing Died No. of episodes Intermittent No. of episodes Constant Constant Mild Moderate Severe Mild Moderate Severe None Dose reduced Dose increased Drug interrupted/restarted Drug stopped None Dose reduced Dose increased Drug interrupted/restarted Drug stopped Not related Unlikely Suspected Probable Not related Unlikely Suspected Probable Corrective Therapy If ‘Yes’, Record details in Concomitant Medication section. Yes No Yes No Was the patient withdrawn due to this specific AE? Yes No Yes No Investigator’s Signature _____________________________________ Date _____________ This template has been freely provided by The Global Health Network. Please adapt it as necessary, reference The Global Health Network when you use it, and share your own materials in exchange. www.theglobalhealthnetwork.org. Protocol Centre Number Patient Number Patient Initials Non-serious Adverse Experiences xxxx/xx NON-SERIOUS ADVERSE EXPERIENCES Page 16b Record any adverse experiences (using medical terminology) observed or elicited by the following direct question to the patient’s parent or guardian: “Has your child appeared different in any way since starting treatment or since the last visit?” Provide the diagnosis not symptoms where possible. One adverse experience per column. Adverse experience. (please print clearly) 3. 4. Onset Date and Time. End Date and Time. (If ongoing please leave blank) Outcome. If patient died please inform sponsor within 24 hrs and complete Form D. Day Month Year 24 Hr:min Day Month Year 24 Hr:min Day Month Year 24 Hr:min Day Month Year 24 Hr:min Resolved Ongoing Died Intermittent Experience course. Intensity (maximum). Action Taken with Respect to Investigational Drug. Relationship to Investigational Drug. Resolved Ongoing Died No. of episodes Intermittent No. of episodes Constant Constant Mild Moderate Severe Mild Moderate Severe None Dose reduced Dose increased Drug interrupted/restarted Drug stopped None Dose reduced Dose increased Drug interrupted/restarted Drug stopped Not related Unlikely Suspected Probable Not related Unlikely Suspected Probable Corrective Therapy If ‘Yes’, Record details in Concomitant Medication section. Yes No Yes No Was the patient withdrawn due to this specific AE? Yes No Yes No Investigator’s Signature _____________________________________ Date _____________ This template has been freely provided by The Global Health Network. Please adapt it as necessary, reference The Global Health Network when you use it, and share your own materials in exchange. www.theglobalhealthnetwork.org. Protocol Centre Number Patient Number Patient Initials Non-serious Adverse Experiences xxxx/xx NON-SERIOUS ADVERSE EXPERIENCES Page 16c Record any adverse experiences (using medical terminology) observed or elicited by the following direct question to the patient’s parent or guardian: “Has your child appeared different in any way since starting treatment or since the last visit?” Provide the diagnosis not symptoms where possible. One adverse experience per column. Adverse experience. (please print clearly) 5. 6. Onset Date and Time. End Date and Time. (If ongoing please leave blank) Outcome. If patient died please inform sponsor within 24 hrs and complete Form D. Day Month Year 24 Hr:min Day Month Year 24 Hr:min Day Month Year 24 Hr:min Day Month Year 24 Hr:min Resolved Ongoing Died Intermittent Experience course. Intensity (maximum). Action Taken with Respect to Investigational Drug. Relationship to Investigational Drug. Resolved Ongoing Died No. of episodes Intermittent No. of episodes Constant Constant Mild Moderate Severe Mild Moderate Severe None Dose reduced Dose increased Drug interrupted/restarted Drug stopped None Dose reduced Dose increased Drug interrupted/restarted Drug stopped Not related Unlikely Suspected Probable Not related Unlikely Suspected Probable Corrective Therapy If ‘Yes’, Record details in Concomitant Medication section. Yes No Yes No Was the patient withdrawn due to this specific AE? Yes No Yes No Investigator’s Signature _____________________________________ Date _____________ This template has been freely provided by The Global Health Network. Please adapt it as necessary, reference The Global Health Network when you use it, and share your own materials in exchange. www.theglobalhealthnetwork.org. INSTRUCTIONS FOR REPORTING SERIOUS ADVERSE EXPERIENCES (SAE) SAE’s MUST BE REPORTED WITHIN 24 HOURS COMPLETE THE SAE PAGES Please complete these pages as fully and accurately as possible in order to minimise the time you spend dealing with data queries. If the SAE is still ongoing at the time of reporting, please leave ‘Experience Course’ blank and update it later. SIGN AND DATE THE SAE PAGE PLEASE ENSURE THAT ALL OF THE INFORMATION ON THE FOLLOWING CRF PAGES IS COMPLETE Demography Significant Medical/Surgical History and Physical Examination Study Medication Record Concomitant Medication Form D (if applicable) PHOTOCOPY THE SAE PAGES AND THE CRF PAGES SPECIFIED ABOVE (Do not separate the NCR pages) FAX A COPY OF THE SAE PAGES AND ALL THE CRF PAGES SPECIFIED ABOVE TO: ……………………………………………… If a photocopier OR fax is NOT available please telephone within 24 hours. This template has been freely provided by The Global Health Network. Please adapt it as necessary, reference The Global Health Network when you use it, and share your own materials in exchange. www.theglobalhealthnetwork.org. Protocol Centre Number Patient Number Patient Initials Serious Adverse Experiences xxxx/xx SERIOUS ADVERSE EXPERIENCE (SAE) Page 17a Person Reporting SAE ______________________________ Serious Adverse Experience. (please print clearly) Specify reason(s) for considering this a serious AE. Mark all that apply 1 2 3 4 …………………….. Onset Date and Time. End Date and Time. (If ongoing please leave blank) Outcome. If patient died , please complete Form D. Day Day Month Year Month Year Action Taken with Respect to Investigational Drug. Relationship to Investigational Drug. Corrective Therapy If ‘Yes’, 24 Hr:min Resolved Ongoing Died 1 Intermittent 2 Constant 1` 2 3 Mild Moderate Severe 1 2 3 4 5 None Dose reduced Dose increased Drug interrupted/restarted Drug stopped Did the SAE abate? Yes No If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)? Yes No If yes, did SAE recur? Yes No 4 3 2 1 Not related Unlikely Suspected Probable Assessment The SAE is probably associated with: Protocol design or procedures (but not study drug) Yes No. of episodes No Record details in Concomitant Medication section. Was the patient withdrawn due 5 6 7 8 9 1 2 3 Experience Course. Intensity (maximum). 24 Hr:min fatal life threatening disabling/incapacitating results in hospitalisation (excluding elective surgery or routine clinical procedures) hospitalisation prolonged congenital abnormality cancer overdose Investigator considers serious or a significant hazard, contraindication, side effect or precaution Please specify ____________________ Another condition (e.g. Condition under study, inter-current illness) Yes No to this specific SAE? Please specify ____________________ Another drug Please specify ____________________ Investigator’s Signature _____________________________________ Date _____________ This template has been freely provided by The Global Health Network. Please adapt it as necessary, reference The Global Health Network when you use it, and share your own materials in exchange. www.theglobalhealthnetwork.org. Protocol Centre Number Patient Number Patient Initials Serious Adverse Experiences xxxx/xx SERIOUS ADVERSE EXPERIENCE (SAE) Page 17b Relevant Laboratory Data Please provide relevant abnormal laboratory data below Test Date | | | | | | | | | | | | | | | | Value | | | | Units Normal range | | | | Remarks (Please provide a brief narrative description of the SAE, attaching extra pages e.g. Hospital discharge summary if necessary) If applicable, was randomisation code broken at investigational site? No Yes Randomisation/Study Medication Number : Investigator’s signature : _________________________________________ (confirming that the above data are accurate and complete) Please PRINT name : Day Month Year Day Month Year _________________________________________ Medical Monitor’s Signature ___________________________________ Date Please PRINT name : Date _____________________________________ This template has been freely provided by The Global Health Network. Please adapt it as necessary, reference The Global Health Network when you use it, and share your own materials in exchange. www.theglobalhealthnetwork.org.
