Targeted Patient Safety Questionnaires.docx
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Targeted patient safety Questionnaires Questionnaire for Haemorrhagic Events Case report Details: …………………………….. Suspect Drug: ……………………………………… Source of report (v) Clinical Trial
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Haemorrhagic Events Details Date of onset :…………………………………….. Description of event: Event
Start date
Suspect drug ……………………. Date started ……………………. Date stopped ………………….. Daily dose ………………………. Indication for therapy …………………………………………………………………. Did the haemorrhagic event result in withdrawal or alteration of dosing? (YES / NO) If yes, please specify ………………………………………………. Was the drug reintroduced (YES/ NO) If yes did the abnormality recur (YES /NO)
Stop date
In your medical judgement is there a reasonable possibility that the drug could have caused this abnormality (YES/NO) Current and Past Medical History:
Any prior administration history with the following drugs (if yes provide the details in the table below) Warfarins (coumarins) ?
YES/NO
Heparin/ Other anticoagulants ?
YES/NO
NSAIDS ?
YES/NO
Concomitant therapy (to include all drugs given one month after haemorrhage)
Previous /Concomitant therapy details
Laboratory data, before, during and after the event (continue on other sheet if needed )
Outcome
YES
NO
Hospitalized Recovery Improvement but sequelae? Death?
Date ………………….
Cause *……………
Disability? * If post mortem report is available kindly attach the same
Investigator’s/Reporter’s signature………………………………………
Date ……………………………..
Liver Injury Data Collection Form Case report Details: …………………………….. Suspect Drug: ……………………………………… Source of report (v) Clinical Trial
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Current and Past History
Liver Injury data collection form continued Date of onset : ………./…../……. Symptoms ? :
YES / NO
Nature of symptoms : Nature of symptoms 1. 2. 3. 4. 5.
……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..…………..
Symptom Start date
Symptom Stop Date
………………………. ………………………. ………………………. ………………………. ……………………….
……………………………. ……………………………. ……………………………. ……………………………. …………………………….
Laboratory Data from before during and after the event: Date (dd/mm/yy) *AST (N<……) *ALT (N<……) *GGT (N<……) *Alk Phos (N<……) *CPK (N<……) Total bilirubin Albumin Creatinine Urea
Date Date (dd/mm/yy) (dd/mm/yy)
Date Date (dd/mm/yy) (dd/mm/yy)
Prothrombin time WCC Haemoglobin Eosinophil Neutrophil
*if any parameter is > or = 3*ULN let Cipla personnel know immediately and complete AE form if appropriate.
Outcome
YES
NO
Hospitalized Recovery Improvement but sequelae? Death?
Date ………………….
Cause *……………
Disability? * If post mortem report is available kindly attach the same
Investigator’s/Reporter’s signature………………………………………
Date ……………………………..
Suspect drug ……………………. Date started ……………………. Date stopped ………………….. Daily dose ………………………. Indication for therapy …………………………………………………………………. Did the LFT result in withdrawal or alteration of dosing? (YES / NO) If yes, please specify ………………………………………………. Was the drug reintroduced (YES/ NO) If yes did the abnormality recur (YES /NO) In your medical judgement is there a reasonable possibility that the drug could have caused this abnormality (YES/NO)
Questionnaire for Patients with ILD Case report Details: …………………………….. Suspect Drug: ……………………………………… Source of report (v) Clinical Trial
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Questionnaire for Cerebrovascular Events Suspect Drug: ……………………………………… Source of report (v) Clinical Trial
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Cerebrovascular event Details Date of onset : ………./…../……. Symptoms ? :
YES / NO
Nature of symptoms : Nature of symptoms 1. 2. 3. 4. 5.
……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..…………..
Symptom Start date
Symptom Stop Date
………………………. ………………………. ………………………. ………………………. ……………………….
……………………………. ……………………………. ……………………………. ……………………………. …………………………….
Suspect drug ……………………. Date started ……………………. Date stopped ………………….. Daily dose ………………………. Indication for therapy …………………………………………………………………. Did the LFT result in withdrawal or alteration of dosing? (YES / NO) If yes, please specify ………………………………………………. Was the drug reintroduced (YES/ NO) If yes did the abnormality recur (YES /NO)
In your medical judgement is there a reasonable possibility that the drug could have caused this abnormality (YES/NO)
Current and Past Medical History Disorder or risk factor CNS tumour/Metastasis Haemophilia or other coagulation disorder Thrombocytopenia Thrombotic or thrombocytopenic purpura Anticoagulation Therapeutic thrombolysis Polycythaemia Rubra Vera Essential thrombocythemia Sickle cell disease Paraproteinemia Disseminated intravascular coagulation Renal failure Liver failure Hypertension Valvular heart disease Vascular malformation Atrial fibrillation Atherosclerosis Previous thrombotic/embolic event Ischemic heart disease Endocarditis Sudden hypotension Sudden hypotension
Current Past Onset date Please specify (YES/NO) (YES/NO) (dd/mm/yy)
Peripheral vascular disease Inflammatory vascular disease Vascular tumours Diabetes mellitus Sepsis Hepatobiliary disease Trauma Surgical procedures Alcohol consumption Tobacco smoking
Any prior administration history with the following drugs? (if yes provide information in the table below) Warfarins (coumarins) ?
YES/NO
Heparin/ Other anticoagulants ?
YES/NO
Anti-Platelet drugs ?
YES/NO
Hormonal therapies ?
YES/NO
Concomitant therapy (to include all the drugs given within 1 month of the cerebrovascular event ) Trade name/drug Name
Route
Daily dose
Start date
Stop date
Indication
Previous /concomitant chemotherapy details Trade name/drug Name
Route
Daily dose
Start date
Stop date
Indication
Start date
Stop date
Indication
Previous /concomitant Radiotherapy details Trade name/drug Name
Route
Daily dose
Test
Date
Ultrasound ECG MRI CT Vessel biopsy Cerebral angiography Other *please attach copy of report
Yes
No
Comments
Outcome
YES
NO
Hospitalized Recovery Improvement but sequelae? Death?
Date ………………….
Cause *……………
Disability? * If post mortem report is available kindly attach the same
Investigator’s/Reporter’s signature………………………………………
Date ……………………………..
Targeted follow up questionnaire – Gastrointestinal Perforation
Details of Suspect Medication
Please circle the appropriate response for the question below Was Gefitinib stopped due to gastrointestinal perforation? Yes/NO Was Gefitinib reintroduced after the event resolved ? Yes/NO
Please provide all details of all concomitant medication taken by the patient prior to or at the time of gastrointestinal perforation in the table below Drug Name
Indication
Route
Daily dose
Start date
Stop date
Please indicate whether the patient’s medical history includes any of the following prior to or at the time of gastrointestinal perforation
Please provide any further relevant information in the space provided or the sheet attached:
Print name and title of person completing form
Signature of person completing form
If physician, specify speciality
Date
If completed by a person in proxy for a physician, please also indicate the following
Name
Job title
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Haemorrhagic Events Details Date of onset :…………………………………….. Description of event: Event
Start date
Suspect drug ……………………. Date started ……………………. Date stopped ………………….. Daily dose ………………………. Indication for therapy …………………………………………………………………. Did the haemorrhagic event result in withdrawal or alteration of dosing? (YES / NO) If yes, please specify ………………………………………………. Was the drug reintroduced (YES/ NO) If yes did the abnormality recur (YES /NO)
Stop date
In your medical judgement is there a reasonable possibility that the drug could have caused this abnormality (YES/NO) Current and Past Medical History:
Any prior administration history with the following drugs (if yes provide the details in the table below) Warfarins (coumarins) ?
YES/NO
Heparin/ Other anticoagulants ?
YES/NO
NSAIDS ?
YES/NO
Concomitant therapy (to include all drugs given one month after haemorrhage)
Previous /Concomitant therapy details
Laboratory data, before, during and after the event (continue on other sheet if needed )
Outcome
YES
NO
Hospitalized Recovery Improvement but sequelae? Death?
Date ………………….
Cause *……………
Disability? * If post mortem report is available kindly attach the same
Investigator’s/Reporter’s signature………………………………………
Date ……………………………..
Liver Injury Data Collection Form Case report Details: …………………………….. Suspect Drug: ……………………………………… Source of report (v) Clinical Trial
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Current and Past History
Liver Injury data collection form continued Date of onset : ………./…../……. Symptoms ? :
YES / NO
Nature of symptoms : Nature of symptoms 1. 2. 3. 4. 5.
……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..…………..
Symptom Start date
Symptom Stop Date
………………………. ………………………. ………………………. ………………………. ……………………….
……………………………. ……………………………. ……………………………. ……………………………. …………………………….
Laboratory Data from before during and after the event: Date (dd/mm/yy) *AST (N<……) *ALT (N<……) *GGT (N<……) *Alk Phos (N<……) *CPK (N<……) Total bilirubin Albumin Creatinine Urea
Date Date (dd/mm/yy) (dd/mm/yy)
Date Date (dd/mm/yy) (dd/mm/yy)
Prothrombin time WCC Haemoglobin Eosinophil Neutrophil
*if any parameter is > or = 3*ULN let Cipla personnel know immediately and complete AE form if appropriate.
Outcome
YES
NO
Hospitalized Recovery Improvement but sequelae? Death?
Date ………………….
Cause *……………
Disability? * If post mortem report is available kindly attach the same
Investigator’s/Reporter’s signature………………………………………
Date ……………………………..
Suspect drug ……………………. Date started ……………………. Date stopped ………………….. Daily dose ………………………. Indication for therapy …………………………………………………………………. Did the LFT result in withdrawal or alteration of dosing? (YES / NO) If yes, please specify ………………………………………………. Was the drug reintroduced (YES/ NO) If yes did the abnormality recur (YES /NO) In your medical judgement is there a reasonable possibility that the drug could have caused this abnormality (YES/NO)
Questionnaire for Patients with ILD Case report Details: …………………………….. Suspect Drug: ……………………………………… Source of report (v) Clinical Trial
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Questionnaire for Cerebrovascular Events Suspect Drug: ……………………………………… Source of report (v) Clinical Trial
If yes complete details below
Spontaneous Other
If yes please specify ………………
Local reference number…………………………… Protocol study/ID……………………………………. Centre ID ……………………………………………….. Patient ID ………………………………………………. Patient Demographic Information Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………
Cerebrovascular event Details Date of onset : ………./…../……. Symptoms ? :
YES / NO
Nature of symptoms : Nature of symptoms 1. 2. 3. 4. 5.
……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..………….. ……………………………..…………..
Symptom Start date
Symptom Stop Date
………………………. ………………………. ………………………. ………………………. ……………………….
……………………………. ……………………………. ……………………………. ……………………………. …………………………….
Suspect drug ……………………. Date started ……………………. Date stopped ………………….. Daily dose ………………………. Indication for therapy …………………………………………………………………. Did the LFT result in withdrawal or alteration of dosing? (YES / NO) If yes, please specify ………………………………………………. Was the drug reintroduced (YES/ NO) If yes did the abnormality recur (YES /NO)
In your medical judgement is there a reasonable possibility that the drug could have caused this abnormality (YES/NO)
Current and Past Medical History Disorder or risk factor CNS tumour/Metastasis Haemophilia or other coagulation disorder Thrombocytopenia Thrombotic or thrombocytopenic purpura Anticoagulation Therapeutic thrombolysis Polycythaemia Rubra Vera Essential thrombocythemia Sickle cell disease Paraproteinemia Disseminated intravascular coagulation Renal failure Liver failure Hypertension Valvular heart disease Vascular malformation Atrial fibrillation Atherosclerosis Previous thrombotic/embolic event Ischemic heart disease Endocarditis Sudden hypotension Sudden hypotension
Current Past Onset date Please specify (YES/NO) (YES/NO) (dd/mm/yy)
Peripheral vascular disease Inflammatory vascular disease Vascular tumours Diabetes mellitus Sepsis Hepatobiliary disease Trauma Surgical procedures Alcohol consumption Tobacco smoking
Any prior administration history with the following drugs? (if yes provide information in the table below) Warfarins (coumarins) ?
YES/NO
Heparin/ Other anticoagulants ?
YES/NO
Anti-Platelet drugs ?
YES/NO
Hormonal therapies ?
YES/NO
Concomitant therapy (to include all the drugs given within 1 month of the cerebrovascular event ) Trade name/drug Name
Route
Daily dose
Start date
Stop date
Indication
Previous /concomitant chemotherapy details Trade name/drug Name
Route
Daily dose
Start date
Stop date
Indication
Start date
Stop date
Indication
Previous /concomitant Radiotherapy details Trade name/drug Name
Route
Daily dose
Test
Date
Ultrasound ECG MRI CT Vessel biopsy Cerebral angiography Other *please attach copy of report
Yes
No
Comments
Outcome
YES
NO
Hospitalized Recovery Improvement but sequelae? Death?
Date ………………….
Cause *……………
Disability? * If post mortem report is available kindly attach the same
Investigator’s/Reporter’s signature………………………………………
Date ……………………………..
Targeted follow up questionnaire – Gastrointestinal Perforation
Details of Suspect Medication
Please circle the appropriate response for the question below Was Gefitinib stopped due to gastrointestinal perforation? Yes/NO Was Gefitinib reintroduced after the event resolved ? Yes/NO
Please provide all details of all concomitant medication taken by the patient prior to or at the time of gastrointestinal perforation in the table below Drug Name
Indication
Route
Daily dose
Start date
Stop date
Please indicate whether the patient’s medical history includes any of the following prior to or at the time of gastrointestinal perforation
Please provide any further relevant information in the space provided or the sheet attached:
Print name and title of person completing form
Signature of person completing form
If physician, specify speciality
Date
If completed by a person in proxy for a physician, please also indicate the following
Name
Job title
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