全英文病例报告表模板

CASE REPORT FORM TEMPLATEVersion: 6.0 (8 November 2012)PROTOCOL: [INSERT PROTOCOL NUMBER][INSERT PROTOCOL TITLE]Participant Study Number:Study group:BASELINE DATAGeneral Instructions for Completion of the Case Report Forms (CRF)Completion of CRFs• A CRF must be completed for each study participant who is successfully enrolled (received at least one dose of study drug)•For reasons of confidentiality, the name and initials of the study participant should not appear on the CRF. General•Please print all entries in BLOCK CAPITAL LETTERS using a black ballpoint pen.•All text and explanatory comments should be brief.•Answer every question explicitly; do not use ditto marks.•Do not leave any question unanswered. If the answer t o a question is unknown, write “NK” (Not Known). If a requested test has not been done, write “ND” (Not Done). If a question is not applicable, write “NA” (Not Applicable).•Where a choice is requested, cross (X) the appropriate response.Dates and Times•All date entries must appear in the format DD-MMM-YYYY e.g. 05-May-2009. The month abbreviations are as follows:January = Jan May = May September = SepFebruary = Feb June = Jun October = OctMarch = Mar July = Jul November = NovApril = Apr August = Aug December = DecIn the absence of a precise date for an event or therapy that precedes the participant’s inclusion into the study,a partial date may be recorded by recording “NK” in the fields that are unknown e.g. where the day and month are not clear, the following may be entered into the CRF: N K N K 2 0 0 9DD MMM YYYY•All time entries must appear in 24-hour format e.g. 13:00. Entries representing midnight should be recorded as 00:00 with the date of the new day that is starting at that time.Correction of Errors•Do not overwrite erroneous entries, or use correction fluid or erasers.•Draw a straight line through the entire erroneous entry without obliterating it.•Clearly enter the correct value next to the original (erroneous) entry.•Date and initial the correction.Protocol Number: Page 1 of 15PARTICIPANT INFORMATIONParticipant NumberStudy Group ______________________________________________ Study Site (Health Centre Name) ______________________________________________Inclusion/exclusion criteria*Patient must meet all criteria to eligible for the studyMet all 1.Not met* 2.Date of Informed ConsentD D M M M Y Y Y YDate of Birth D D M M M Y Y Y YOr estimated age_______Gender 1Male2FemalePregnant 1.Yes2. No9. Unknown If pregnant, Estimated Gestational Age ___________weeksDate of EnrolmentD D M M M Y Y Y YHad malaria in the last 28 days 1. Yes2. No9. Unknown Had antimalarial in the last 28 days 1. Yes2. No9. UnknownBASELINE SYMPTOMSFever (in last 24 hours) 1. Yes2. No Duration: _______ days Dizziness 1. Yes2. No Duration: _______ days Headache 1. Yes2. No Duration: _______ days Nausea 1. Yes2. No Duration: _______ days Anorexia 1. Yes2. No Duration: _______ days Vomiting 1. Yes2. No Duration: _______ days Diarrhoea 1. Yes2. No Duration: _______ days Abdominal pain 1. Yes2. No Duration: _______ days Itching 1. Yes2. No Duration: _______ days Skin rash 1. Yes2. No Duration: _______ days Urticaria 1. Yes2. No Duration: _______ days Joint pain 1. Yes2. No Duration: _______ days Muscle pain 1. Yes2. No Duration: _______ days Palpitations 1. Yes2. No Duration: _______ days Dyspnoea 1. Yes2. No Duration: _______ days Hearing problem 1. Yes2. No Duration: _______ days Confusion 1. Yes2. No Duration: _______ days Visual blurring 1. Yes2. No Duration: _______ days Fatigue 1. Yes2. No Duration: _______ days Other symptom: ____________________ Duration: _______ days Other symptom: ____________________ Duration: _______ days Other symptom: ____________________ Duration: _______ daysMEDICATION HISTORY (within the last 7 days)- Make multiple copies of this page if requiredMedication Name(write NK if unknown)Start Date Stop Date______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 Ongoing______________________________D D M M M Y Y Y Y D D M M M Y Y Y Y OR 1 Unknown OR 1 OngoingSIGNIFICANT MEDICAL HISTORY (within the past 5 years)- Make multiple copies of this page if requiredDoes the participant have a history of any background/concomitant conditions/symptoms according to the following schedule? 1 Yes 2 NoIf Yes, detail in the table below and reference the ICD10 system codehttp://apps.who.int/classifications/apps/icd/icd10online/Code Title Code Title1 Certain infectious and parasitic diseases 12 Diseases of the skin and subcutaneous tissue2 Neoplasms 13 Diseases of the musculoskeletal system and connective tissue3 Diseases of the blood and blood-forming organs andcertain disorders involving the immune mechanism14 Diseases of the genitourinary system4 Endocrine, nutritional and metabolic diseases 15 Pregnancy, childbirth and the puerperium5 Mental and behavioural disorders 16 Certain conditions originating in the perinatal period6 Diseases of the nervous system 17 Congenital malformations, deformations and chromosomal abnormalities7 Diseases of the eye and adnexa 18 Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified8 Diseases of the ear and mastoid process 19 Injury, poisoning and certain other consequences of external causes9 Diseases of the circulatory system 20 External causes of morbidity and mortality10 Diseases of the respiratory system 21 Factors influencing health status and contact with health services11 Diseases of the digestive system 22 Codes for special purposes SIGNIFICANT MEDICAL HISTORY (within the past 5 years)Code Condition/Symptom Onset Date Stop DateD D M M M Y Y Y Y D D M M M Y Y Y YOR 1 Unknown OR 1 OngoingD D M M M Y Y Y Y D D M M M Y Y Y YOR 1 Unknown OR 1 OngoingD D M M M Y Y Y Y D D M M M Y Y Y YOR 1 Unknown OR 1 OngoingD D M M M Y Y Y Y D D M M M Y Y Y YOR 1 Unknown OR 1 OngoingD D M M M Y Y Y Y D D M M M Y Y Y YOR 1 Unknown OR 1 OngoingBASELINE PHYSICAL EXAMINATION – PART 1 Weight . kg Height. cmTemperature . C Method of RecordingHeart ratebpm Axillary Tympanic Rectal Oral1234Respiratory rate bpmBlood pressure/ mmHgHepatomegaly 1. Yes2. Nocm If yes, size:Splenomegaly 1. Yes2. Nocm If yes, size:Normal Abnormal Specify if abnormalCentral Nervous System 1.2.________________________________________Cardiovascular System 1.2.________________________________________Respiratory System 1.2.________________________________________Gastrointestinal System 1.2.________________________________________Skin 1.2.________________________________________Joints 1.2.________________________________________BASELINE PHYSICAL EXAMINATION – PART 2Danger signs or features of severe malaria?(If no symptoms tick box on the right. Otherwise complete list below)No symptoms2YesNoNotKnownC l i n i c a l m a n i f e s t a t i o n sImpaired consciousness1299Prostration1 2 99Multiple convulsions1 2 99Respiratory distress (metabolic acidotic) 1 2 99Circulatory collapse 1 2 99Jaundice 1 2 99Haemoglobinuria 1 2 99Abnormal bleeding1 2 99Pulmonary oedema (radiological)1 2 99L a b o r a t o r y f i n d i n g sHypoglycaemia (blood glucose <2.2 mmol/l or <40 mg/dl 1 2 99Acidosis (plasma bicarbonate <15 mmol/l) 1 2 99Severe anaemia (Hb < 5g/dl or haematocrit <15%) 1 2 99Hyperparasitaemia (>4% in non-immune patients) 1 2 99Hyperlactataemia (venous lactic acid >5 mmol/l)1 2 99Renal impairment (serum creatinine above normal range for age)12 99HAEMATOLOGYParticipant NumberHAEMATOLOGY – make multiple copies of this page if requiredD a y 0DateTime 24hrHb (g/dL)Hct (%)WBC (109/L)D D M M M Y Y Y YH H : M M... Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Platelets (109/L).-.... D a y _DateTime 24hr Hb (g/dL) Hct (%) WBC (109/L)D D M M M Y Y Y YH H : M M... Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Platelets (109/L).-.... D a y _DateTime 24hr Hb (g/dL) Hct (%) WBC (109/L)D D M M M Y Y Y YH H : M M... Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Platelets (109/L).-....D a y _DateTime 24hr Hb (g/dL) Hct (%) WBC (109/L)D D M M M Y Y Y YH H : M M... Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Platelets (109/L).-....D a y _DateTime 24hr Hb (g/dL) Hct (%) WBC (109/L)D D M M M Y Y Y YH H : M M... Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Platelets (109/L).-....D a y _DateTime 24hr Hb (g/dL) Hct (%) WBC (109/L)D D M M M Y Y Y YH H : M M... Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Platelets (109/L). - .... D a y _DateTime 24hr Hb (g/dL) Hct (%) WBC (109/L)D D M M M Y Y Y YH H : M M... Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Platelets (109/L). - ....PHYSICAL EXAMINATIONParticipant NumberPHYSICAL EXAMINATION: DAY_ – make multiple copies of this page if requiredDateD D M M M Y Y Y YTime HH : M MWeight.kgHeight.cmTemperature.CMethod of RecordingHeart ratebpmAxillaryTympanicRectalOral1234Respiratory ratebpmBlood pressure/mmHepatomegaly 1. Yes 2. No cm If yes, size: Splenomegaly1. Yes2. NocmIf yes, size:Danger signs or features of severe malaria?(If no symptoms tick box on the right. Otherwise complete list below)No symptoms2YesNoNot KnownC l i n i c a l m a n i f e s t a t i o n sImpaired consciousness1299Prostration1 2 99Multiple convulsions1 2 99Respiratory distress (metabolic acidotic) 1 2 99Circulatory collapse 1 2 99Jaundice 1 2 99Haemoglobinuria 1 2 99Abnormal bleeding1 2 99Pulmonary oedema (radiological)1 2 99L a b o r a t o r y f i n d i n g sHypoglycaemia (blood glucose <2.2 mmol/l or <40 mg/dl 1 2 99Acidosis (plasma bicarbonate <15 mmol/l) 1 2 99Severe anaemia (Hb < 5g/dl or haematocrit <15%) 1 2 99Hyperparasitaemia (>4% in non-immune patients) 1 2 99Hyperlactataemia (venous lactic acid >5 mmol/l)1 2 99Renal impairment (serum creatinine above normal range for age)12 99Are there new symptoms or is the patient showing a worsening from baseline ?1. Yes2. NoSYMPTOM CHECKParticipant NumberSYMPTOM CHECK – make multiple copies of this page if requiredD a y _DateFeverDizziness HeadacheNauseaAnorexiaVomitingDiarrhoeaAbdominal painItchingD D M M M Y Y Y YYes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Time 24hr Skin rashUrticariaJoint painMuscle pain PalpitationsDyspnoeaHearing problemConfusionVisual blurringFatigueH H : M MYes ☐ No☐Yes ☐ No☐Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐D a y _DateFeverDizziness HeadacheNauseaAnorexiaVomitingDiarrhoeaAbdominal painItchingD D M M M Y Y Y YYes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Time 24hr Skin rashUrticariaJoint painMuscle pain PalpitationsDyspnoeaHearing problemConfusionVisual blurringFatigueH H : M MYes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐ Yes ☐ No☐Yes ☐ No☐D a y _DateFeverDizziness HeadacheNauseaAnorexiaVomitingDiarrhoeaAbdominal painItchingD D M M M Y Y Y YYes ☐ No☐Yes ☐ No☐Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Time 24hr Skin rashUrticariaJoint pain Muscle pain PalpitationsDyspnoeaHearing problemConfusionVisual blurringFatigueH H : M MYes ☐ No☐Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐Yes ☐ No☐ Yes ☐ No☐ Yes ☐ No☐PARASITEMIAParticipant NumberPARASITEMIA – make multiple copies of this page if requiredD a y _Date smear takenTime smear takenMalaria species(Record counts for different species on separate rows) Parasite count Units (tick one)☐ /1000RBC ☐ /200WBC ☐ /500WBC ☐ /µLGametocytesGametocytecountUnits (tick one)☐ /1000RBC☐ /200WBC ☐ /500WBC☐ /µLPCR/DNA sample collected?D D M M M Y Y Y YH H : M MPFPVPOPMYesNoYesNo1234121 2D a y _Date smear takenTime smear takenMalaria species(Record counts for different species on separate rows)Parasite countUnits (tick one)☐ /1000RBC ☐ /200WBC ☐ /500WBC ☐ /µLGametocytesGametocytecountUnits (tick one)☐ /1000RBC☐ /200WBC ☐ /500WBC☐ /µLPCR/DNA sample collected?D D M M M Y Y Y YH H : M MPFPVPOPMYesNoYesNo1234121 2D a y _Date smear takenTime smear takenMalaria species(Record counts for different species on separate rows)Parasite countUnits (tick one)☐ /1000RBC ☐ /200WBC ☐ /500WBC ☐ /µLGametocytesGametocytecountUnits (tick one)☐ /1000RBC☐ /200WBC ☐ /500WBC☐ /µLPCR/DNA sample collected?D D M M M Y Y Y YH H : M MPFPVPOPMYesNoYesNo1234121 2D a y _Date smear takenTime smear takenMalaria species(Record counts for different species on separate rows)Parasite countUnits (tick one)☐ /1000RBC ☐ /200WBC ☐ /500WBC ☐ /µLGametocytesGametocytecountUnits (tick one)☐ /1000RBC☐ /200WBC ☐ /500WBC☐ /µLPCR/DNA sample collected?D D M M M Y Y Y YH H : M MPFPVPOPMYesNoYesNo1234121 2CASE REPORT FORM TEMPLATEMOLECULAR GENOTYPE Participant NumberPHARMACOKINETIC PROFILEDate Time Sample numberD D M M M Y Y Y Y H H :M MB00D D M M M Y Y Y Y H H :M MB01D D M M M Y Y Y Y H H :M MB02D D M M M Y Y Y Y H H :M MB03D D M M M Y Y Y Y H H :M MB04D D M M M Y Y Y Y H H :M MB05D D M M M Y Y Y Y H H :M MB06D D M M M Y Y Y Y H H :M MB07D D M M M Y Y Y Y H H :M MB08D D M M M Y Y Y Y H H :M MB09D D M M M Y Y Y Y H H :M MB10D D M M M Y Y Y Y H H :M MB11D D M M M Y Y Y Y H H :M MB12STUDY DRUG ADMINISTRATIONParticipant NumberSTUDY DRUG ADMINSTRATION –make multiple copies of this page if requiredStudy drug Dose Treatmentobserved?Date of dose Time of dose Vomited?Time ofvomitRetreatment?RetreatmentdoseTime ofretreatment___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M M___________ ______Yes ☐No ☐D D M M M Y Y Y Y H H :M MYes ☐No ☐H H :M MYes ☐No ☐______H H :M MCONCOMITANT MEDICATIONSParticipant NumberCONCOMITANT MEDICATIONS – make multiple copies of this page if requiredMedicationnameFormulation Dose Units Frequency Route Date started Date stopped Ongoing? Indication___________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐______________________ __________________________ D D M M M Y Y Y Y D D M M M Y Y Y Y Yes ☐No ☐___________ADVERSE EVENTSParticipant NumberADVERSE EVENTS – make multiple copies of this page if requiredAdverse event nameIntensity 1 Mild 2 Moderate 3 SevereIf SAE specify: 1Death2Life-threatening3Persistent or symptomatic disability or incapacity 4Hospitalisation or prolongation of hospitalisation 5Congenital anomaly or birth defect6Other important medical eventOnset Date D D M M M Y Y Y YEnd Date D D M M M Y Y Y Y OR Ongoing at the end of studyTherapy 1None3Other 2Drug4Drug and otherAction Taken with Study Drug 1Dose unchanged4Drug withdrawn99Not Known2Dose reduced5 Dose increased3Drug temporarily interruptedOutcome 1Recovered3Recovering with sequelae5Fatal 2Recovering 4Continuing 99Not KnownRelationship to Study drug 1Certain4Unlikely2Probable5Not related3Possible6UnclassifiedFINAL STUDY OUTCOMEParticipant NumberFINAL STUDY OUTCOMESubject has completed the study?1Completiondate :D D M M M Y Y Y YIf NOT completed specify last follow up date:D D M M M Y Y Y YReason not completed: (Tick only one box)1Significant non-compliance2Drug-related AE3Treatment failure4Consent withdrawn5Lost to follow-up6Other (specify) ____________________Remarks:Investigator's Statement: I have reviewed the data recorded in this CRF and confirm that the data are complete and accurateInvestigator (Full name): _________________________________________Investigator Signed? 1Signature Date: D D M M M Y Y Y Y。