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SAMPLE SOURCE DOCUMENT Investigator Sponsor _____________________ _____________________ Visit # Protocol # Visit Date: ______________ __________ __________ Visit Time ____:____(24 hour clock) Patient Information Patient Initials _________________________ Patient Screening # ______________Patient Randomisation # __________________ Laboratory Laboratory testing Yes No Date (dd/mo/yr)_____/____/____ Initials______ Normal Clinically significant Not clinically significant If CS, list and provide details _______________________________________________________________________________ _______________________________________________________________________________ Vital Signs Wt: _______ Ht: _________ BP: ______ Pulse: ________ Initials____________ ECG Date(dd/mo/yr)___/___/___ Normal Clinically significant Not clinically significant If CS, provide comments _______________________________________________________________________________ _______________________________________________________________________________ Xray Yes No Date (dd/mo/yr)_____/____/____ Site(s)___________________________ Normal Clinically significant Not clinically significant If CS, list and provide details _______________________________________________________________________________ _______________________________________________________________________________ Concurrent Medications If yes, list: Drug Dose Unit Yes No Frequency Route Date Started dd/mo/yr Date Stopped dd/mo/yr Indication Adverse events since last visit Yes If yes, list Adverse Event Start Stop Date Date No Intensity (mild, mod, severe) Relationship to study drug (yes/no) Comments, Action Taken Study Medication Study meds dispensed Yes No Amt Dispensed________ Study meds returned Yes No Amt Returned (from count)________ # days since last visit______ #expected used_______ #actual used (#dispensed - # returned)_______ Physical Examination (note: free flowing text from the investigator according to normal practise is preferred by most industry and regulatory representatives for reporting P/E) Head: Normal Abnormal Not Done Explain: Eye: Normal Abnormal Not Done Explain: Ear: Normal Abnormal Not Done Explain: Nose: Normal Abnormal Not Done Explain: Throat: Normal Abnormal Not Done Explain: Neck: Normal Abnormal Not Done Explain: Lymph Node: Normal Abnormal Not Done Explain: Breast: Normal Abnormal Not Done Explain: Heart: Normal Abnormal Not Done Explain: Abdomen: Normal Abnormal Not Done Explain: Lung/thorax: Normal Abnormal Not Done Explain: GenitoUrin: Normal Abnormal Not Done Explain: Extremities: Normal Abnormal Not Done Explain: Musculo-SK: Normal Abnormal Not Done Explain: Skin: Normal Abnormal Not Done Explain: Neuro: Normal Abnormal Not Done Explain: Investigator Signature_____________________________________Date__________________ Medical History (note: free flowing text from the investigator according to normal practise is preferred by most industry and regulatory representatives for reporting medical history) Head/Eyes/Ears/Throat: Normal Central Nervous Syst: Normal Blood/Lymph: Normal Skin/Hair: Normal Cardiovascular: Normal Respiratory: Normal Gastro-intestinal: Normal Genito-urinary: Normal Musculo-skeletal: Normal Endocrine: Normal Allergic: Normal Psychiatric: Normal Drug/Alcohol abuse: Normal Other: Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Abnormal Explain: Explain: Explain: Explain: Explain: Explain: Explain: Explain: Explain: Explain: Explain: Explain: Explain: Investigator Signature_____________________________________Date__________________ Patient Records Patient diary/questionnaire dispensed yes no Patient diary/questionnaire reviewed with patient yes no Patient diary/questionnaire completed correctly yes no (note: diaries and patient questionnaires are to be completed or changed by the patient only) If no, provide explanation _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ Rescue Medication Rescue medication dispensed Yes No Amt Dispensed________ Rescue meds returned Yes No Amt Returned (from count)________ Rescue meds taken Yes No If yes, amount used (=amt dispensed – amt returned)_______________ Comments (eg. date(s) rescue taken, details of rescue taken, source of information (patient diary vs recall vs telephone) _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________
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