Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
CRF Template – Instructions CRF template version 14, 10.09.15 Please use this template as the basis for designing the Case Report Forms for your CTIMP. Please add or delete sections or pages on this template as required and ensure that data required in the protocol from all trial visits and data relating to endpoints defined in the protocol are captured in this CRF. It is also important that you ensure that you do not collect any data which is not required in your protocol, for instance if you are not required to collect alcohol and smoking history at screening you should delete this page in the template. The following pages/sections should be included in every CRF: Front page CRF Completion Instructions Demographics (if you do record ethnicity the categories provided are from the 2001 Census) Inclusion and Exclusion Criteria Eligibility Review and sign off Trial Medication Administration (choose the appropriate method of administration, or add your own) Trial Assessments Trial completion Chief/Principal Investigator’s sign off Changes in health log Concomitant Medications log Adverse events log Protocol deviations log As well as the compulsory sections above, this template includes a number of elective forms (for instance for laboratory results); these are by no means exhaustive and cannot cover every possible investigation, you should design these study specific forms yourself. If you will be repeating investigations if they are out of range (for instance blood pressure or bloods), please add pages for these, clearly marking them ‘repeats’. Text given in blue should be completed or deleted if not to be used. Please change the colour of all the text to black and white before printing. Delete Screening number if not applicable and just use Subject No. and Patients Initials only. Likewise delete Centre No. if not applicable. When drafting the CRF, keep the version number in the footer as 1 and up-date the date with every new draft. Keep draft as a watermark if preferred. The first version to be used with the first study patient will be version 1. If any changes are made after that then up-date the version number as well as the date. This instruction page should be deleted once you have designed your CRF, so that the front cover is page 1. SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 1 of 29 CASE REPORT FORM Trial Title Short Title/Acronym Chief or Principal Investigator: EudraCT Number: Name of site: Patient Initials Subject No. Screening No. Centre No. SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 2 of 29 CRF Completion Instructions General Complete the CRF using a black ballpoint pen and ensure that all entries are complete and legible. Avoid the use of abbreviations and acronyms. The CRF should be completed as soon as possible after the scheduled visit. Do not use subject identifiers anywhere on the CRF, such as name, hospital number etc., in order to maintain the confidentiality of the subject. Ensure that the header information (i.e. subject’s initials and ID number) is completed consistently throughout the CRF. Missing initials should be recorded with a dash (i.e. D-L). Each CRF visit should be signed and dated by the person completing the visit. CRFs should only be completed by individuals delegated to complete CRFs on the Site Delegation log (and signed by the PI). Ensure that all fields are completed on each page: If a test was Not Done record ND in the relevant box(es) Where information is Not Known write NK in relevant box(es) Where information is not applicable write NA in the relevant box(es) Corrections to entries If an error is made, draw a single line through the item, then write the correct entry on an appropriate blank space near the original data point on the CRF and initial and date the change. Do NOT Obscure the original entry by scribbling it out Try to correct nor modify the original entry Use Tippex or correction fluid Medications taken by the subject during the trial should be recorded on the “Concomitant Medications Log” using the generic name whenever possible, except combination products which will be recorded using the established trade name. Complete all dates as day, month, year e.g. 13/11/14. Partial dates should be recorded as NK/11/14. All times are to be recorded in 24 hour format without punctuation and always use 4-digits; i.e. 0200 or 2130. Midnight is recorded as 0000. Weights should be recorded to the nearest 0.1 kg. Investigation results All investigation results (pathology, radiology, histology, ECG etc) required according to the protocol are study data and must either be recorded in the CRF or printed out and filed in the CRF. All investigation results must be reviewed, signed and dated by a study medic. If these results are also part of the patient’s routine care then a copy of the results must also be in the patient’s casenotes. All rating scales and questionnaires completed by patients must be filed in the appropriate visit of the CRF. All print outs of results, scales and questionnaires filed in the CRF should be clearly dated and identified by patients initials and study number. Any clinically significant results that are different from baseline should be recorded as AEs unless expected according to the protocol. SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 3 of 29 If a clinically significant result is not considered to be an AE then record the reason why next to the result. Withdrawn subjects If a subject prematurely withdraws from the trial, ensure that the Trial Completion page is completed. Protocol deviations Any protocol deviations, violations or serious breach should be recorded on the Protocol Deviations Log at the end of the CRF. This includes reasons for delayed or missed protocol visits or trial assessments, unscheduled visits, equipment failure etc. Protocol deviations are to be taken into account in the study analysis and publication. CI/PI sign off The Chief Investigator (for lead site)/Principal Investigator is responsible for the accuracy of the data reported on the CRF. The CI/PI must sign and date the Chief/Principal Investigator’s Sign Off page to certify accuracy, completeness and legibility of the data reported in the CRF. Serious Adverse Events (SAEs) SAE report forms should be completed electronically and either scanned and emailed to the R&D monitor (or QA manager/R&D manager in the monitor’s absence) or faxed to 01482 461886 within 24 hours of the site being aware of the event. Storage CRF documents should be stored in a locked, secure area when not in use where confidentiality can be maintained. SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 4 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name VISIT 1 (SCREENING/BASELINE) DEMOGRAPHIC DATA Date of Visit: __ __ / __ __ / __ __ dd/mm/yy Informed Consent Checklist Yes 1. Has the patient read and understood the Patient Information Sheet? 2. Has the patient signed and dated the correct version of the consent form? The patient must be consented prior to the first trial-related procedure 3. Has the patient received a copy of the signed consent form? No Demographic Data Date of Birth __ __ / __ __ / __ __ __ __ Sex Male Female dd/mm/yyyy Ethnicity White Asian Black Chinese Mixed race Other (please specify below) ___________________________________________ Alcohol consumption Patient’s average number of units per week: ____________ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 5 of 29 < Short Title/Acronym> Subject/Scr eening No. Patient Initials Site Name VISIT 1 (SCREENING/BASELINE) MEDICAL HISTORY & HEALTH STATUS Date of Assessment: __ __ / __ __ / __ __ dd/mm/yy Health Status Has the patient had any relevant medical history in the last 10 years? Condition / illness / surgical procedure No Yes, Complete below Start date Stop date dd/mm/yy dd/mm/yy Or tick if ongoing at Screening/Ba seline Visit? ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ Concomitant Medications Yes No Is the participant taking any Concomitant Medications? If yes, please record in Concomitant Medications Log at end of CRF SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 6 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name VISIT 1 (SCREENING/BASELINE) PHYSICAL EXAM Date of Assessment: __ __ / __ __ / __ __ dd/mm/yy Was Physical Examination performed? System *Abnormal Normal No Not done Yes, Complete below *If noted ABNORMAL, please provide brief description and comment if clinically significant or not (CS/NCS) General Appearance Skin Eyes, Ears, Nose & Throat Head, Neck & Thyroid Cardiovascular Respiratory Abdomen Extremities Genitalia Anorectal Lymph Nodes Muscular-Skeletal Neurological Others (please specify) SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 7 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name VISIT 1 (SCREENING/BASELINE) VITAL SIGNS & ECG Were Vital Signs performed? No (comment below) Yes, Complete below Comment*: __________________ __ __ / __ __ / __ __ Date of Vital Signs: dd/mm/yy ________:_______ Time of Vital Signs: HH:MM Blood Pressure supine/standing/seating : Pulse: ____ ___ ___ beats/min Weight: ___ ___ ___ . ___ kg Oral/ Tympanic Temperature: ___ ___ ___ / ___ ___ ___ mmHg Height: ___ . ___ ___ m ___ ___ . ___ °C No (comment below) Was an ECG performed? Yes, Complete below Comment*: __________________ __ __ / __ __ / __ __ Date & time of ECG: dd/mm/yy ________:_______ HH:MM Within normal limits Abnormal, NOT clinically significant The ECG is: Abnormal, clinically significant, please specify: _____________________________________________________________ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 8 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name VISIT 1 (SCREENING/BASELINE) LAB TESTS Laboratory tests Have blood/urine/tissue samples been taken for the tests listed below? Yes, date samples taken: __ __ / __ __ / __ __ Time sample taken ________:_______ HH:MM No, give reason:_______________________________________ Blood/urine/tissue test Done? Yes No Reason if not done Have test results that are outside normal limits been printed off from Patient Centre and checked, signed and dated by CI/PI/study medic? Yes No, give reason:_______________________________________ Have these results been filed in the CRF? Yes No, give reason:_______________________________________ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 9 of 29 < Short Title/Acronym> Subject/Scr eening No. Patient Initials Site Name VISIT 1 (SCREENING/BASELINE) < INSERT ASSESSMENT> Clinical <insert assessment> Laboratory tests performed? No (comment below) Yes, Complete below Comment *: __________________ __ __ / __ __ / __ __ Date of Sample: dd/mm/yy ________:_______ Time of Sample HH:MM No Was laboratory sample taken at different hospital to <insert investigator’s site lab name>? Yes, Complete below Laboratory name / Location: __________________________________________ <INSERT ASSESSMENT> Value Laboratory Parameter SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Unit (site to pre-complete prior to the finalization of the template) If parameter indicated as out of normal range on report, please check if clinically significant: No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes Page 10 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name VISIT 1 (SCREENING/BASELINE) SMOKING / ALCOHOL STATUS Date of Assessment: __ __ / __ __ / __ __ dd/mm/yy Has the participant ever smoked? Current Smoker No Yes, Complete below Participant’s average daily use: - Number of cigarettes : ___ ___ - Number of cigars : ____ ___ - Number of pipes : ___ ___ Smoked for ___ ___ months/years Smoked for ___ ___ months/years Former smoker Date when smoking ceased: __ __ / __ __ / __ __ dd/mm/yy When smoking, participant’s average daily use: - Number of cigarettes : ___ ___ - Number of cigars : ____ ___ - Number of pipes : ___ ___ Participant’s alcohol consumption Participant’s average consumption per <insert time frame stated in protocol>: - Number of units of wine : ___ ___ - Number of units of beer : ____ ___ - Number of units of spirits : ___ ___ (see protocol for definition of units) SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 11 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name VISIT 1 (SCREENING/BASELINE) ELIGIBILITY CRITERIA Date of Assessment: __ __ / __ __ / __ __ dd/mm/yy Inclusion Criteria - include if ‘yes’ to all 1. Yes No Yes No Adults ≥18 years 2. 3. 4. Able to provide written informed consent. 5. Able to complete study assessments 6. Exclusion Criteria - exclude if ‘yes’ to any 1. 2. 3. 5. 6. 7. Pregnancy 8. Involvement in another CTIMP within the past four weeks SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 12 of 29 < Short Title/Acronym> Subject/Scr eening No. Patient Initials Site Name VISIT 1 (SCREENING/BASELINE) PARTICIPANT ELIGIBILITY SIGN-OFF Participant’s eligibility Investigator Sign-Off Is the participant eligible to take part in the trial? Yes Study doctor on the Delegation Log Signature: __________________ Date : __ __ / __ __ / __ __ No, Please give reason for screen failure below Reason(s) for screen failure: End of Screening/Baseline visit checklist Yes 1. Have all Screening/Baseline Visit procedures been completed? 2. Have there been any protocol deviations or violations? If yes, please record on the Protocol Deviations Log at end of CRF 3. Has the GP letter been sent? 4. Is the patient continuing with the study? If not, complete Trial Completion page at end of CRF. No Visit completed by: Name SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Signature Date Page 13 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name VISIT X <INSERT VISIT NAME> RANDOMISATION/ENROLMENT Participant Randomisation/Enrolment Participant study Number allocated: ____ ____ ____ __ __ / __ __ __ / __ __ __ __ Date of Randomisation/Enrolment: dd/mm/yy VISIT X <INSERT VISIT NAME> TRIAL MEDICATION ADIMINSTRATION <Insert name of trial medication> Administration CHOOSE APPROPRIATE DOSING/DISPENSING TABLE FOR YOUR PROTOCOL AND MODIFY AS REQUIRED Date of Dosing dd/mm/yy Time of Dosing (24 hr) ____/____/____ ____ ____:____ ____ ____/____/____ ____ ____:____ ____ Start date of dosing dd/mm/yy Stop date of dosing dd/mm/yy ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Dose (including units) Dose (including units) Comment ONLY if dose delayed, interrupted, reduced or altered Comment ONLY if dose delayed, interrupted, reduced or altered Page 14 of 29 < Short Title/Acronym> Subject/Scr eening No. Site Patient Initials Name INFUSION Date of Infusion dd/mm/yy Start time of infusion Stop time of infusion ____/____/____ ______:______ ______:______ ____/____/____ ______:______ ______:______ Dose (including units) Comment ONLY if dose delayed, interrupted, reduced or altered VISIT X <INSERT VISIT NAME> TRIAL MEDICATION DISPENSING DISPENSING Date of Dispensing IMP dd/mm/yy Quantity Dispensed (no. tablets/ pens/patches) <Daily> Dose (including units) Comment ONLY if dose delayed, reduced or altered ____/____/____ Note: add more rows depending on how IMP is dispensed and Returned RETURNS (add to subsequent visit) Date of Returning IMP dd/mm/yy Quantity Returned (no. tablets/ pens/patches) Comment on compliance ____/____/____ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 15 of 29 < Short Title/Acronym> Subject/Scre ening No. Patient Initials Site Name VISIT X <INSERT VISIT NAME> BEGINNING OF VISIT CHECKLIST Date of Visit: __ __ / __ __ / __ __ Beginning of Visit Checklist 1. Patient happy to proceed in study? 2. Have there been any changes in the patient’s health since baseline? If yes, please record in Changes in Health Log at end of CRF 3. Have there been any Adverse Events? If yes, please record in Adverse Events Log 4. Yes No Have there been any changes in Concomitant Medications since baseline? If yes, please record in Concomitant Medications Log SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 16 of 29 < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name VISIT X <INSERT VISIT NAME> PHYSICAL EXAM SIT X <INSERT VISIT NAME> Date of Assessment: __ __ / __ __ / __ __ dd/mm/yy Was Physical Examination performed? System *Abnormal Normal No Not done Yes, Complete below *If noted ABNORMAL, please provide brief description and comment if clinically significant or not (CS/NCS) General Appearance Skin Eyes, Ears, Nose & Throat Head, Neck & Thyroid Cardiovascular Respiratory Abdomen Extremities Genitalia Anorectal Lymph Nodes Muscular-Skeletal Neurological Others (please specify) SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 17 of 29 < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name VISIT X <INSERT VISIT NAME> VITAL SIGNS & ECG Were Vital Signs performed? No (comment below) Yes, Complete below Comment*: __________________ __ __ / __ __ / __ __ __ Date of Vital Signs: dd/mm/yy ________:_______ Time of Vital Signs: HH:MM Blood Pressure supine/standing/seating : Pulse: ____ ___ ___ beats/min Weight: ___ ___ ___ . ___ kg Oral/ Tympanic Temperature: ___ ___ ___ / ___ ___ ___ mmHg Height: ___ . ___ ___ m ___ ___ . ___ °C No (comment below) Was an ECG performed? Yes, Complete below Comment*: __________________ __ __ / __ __ / __ __ Date & time of ECG: dd/mm/yy ________:_______ HH:MM Within normal limits Abnormal, NOT clinically significant The ECG is: Abnormal, clinically significant, please specify: _____________________________________________________________ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 18 of 29 < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name VISIT X <INSERT VISIT NAME> LAB TESTS Laboratory tests Have blood/urine/tissue samples been taken for the tests listed below? Yes, date samples taken: __ __ / __ __ / __ __ dd/mm/yy Time of Sample ________:_______ HH:MM No, give reason:_______________________________________ Blood/urine/tissue test Done? Yes No Reason if not done Have test results that are outside normal limits been printed off from Patient Centre and checked, signed and dated by CI/PI/study medic? Yes No, give reason:_______________________________________ Have these results been filed in the CRF? Yes No, give reason:_______________________________________ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 19 of 29 < Short Title/Acronym> Subject/Scre ening No. Patient Initials Site Name VISIT X <INSERT VISIT NAME> < INSERT ASSESSMENT> Clinical <insert assessment> Laboratory tests performed? No (comment below) Yes, Complete below Comment *: __________________ __ __ / __ __ __ / __ __ __ __ Date of Sample: dd/mm/yy ________:_______ Time of Sample HH:MM No Was laboratory sample taken at different hospital to <insert investigator’s site lab name>? Yes, Complete below Laboratory name / Location: __________________________________________ <INSERT ASSESSMENT> Value Laboratory Parameter SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Unit (site to pre-complete prior to the finalization of the template) If parameter indicated as out of normal range on report, please check if clinically significant: No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes Page 20 of 29 < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name VISIT X <INSERT VISIT NAME>< ASSESSMENT PERFORMED> <Insert other assessments> VISIT X <INSERT VISIT NAME> TRIAL MEDICATION ADIMINSTRATION <Insert name of trial medication> Administration CHOOSE APPROPRIATE DOSING/DISPENSING TABLE FOR YOUR PROTOCOL AND MODIFY AS REQUIRED Date of Dosing dd/mm/yy Time of Dosing (24 hr) Dose (including units) ____/_____/______ ____ ____:____ ____ ____/_____/______ ____ ____:____ ____ Start date of dosing dd/mm/yy Stop date of dosing dd/mm/yy ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ Dose (including units) Comment ONLY if dose delayed, interrupted, reduced or altered Comment ONLY if dose delayed, interrupted, reduced or altered INFUSION Date of Infusion dd/mm/yy Start time of infusion Stop time of infusion ____/_____/______ ______:______ ______:______ ____/_____/______ ______:______ ______:______ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Dose (including units) Comment ONLY if dose delayed, interrupted, reduced or altered Page 21 of 29 < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name VISIT X <INSERT VISIT NAME> TRIAL MEDICATION DISPENSING DISPENSING Date of Dispensing IMP dd/mm/yy Quantity Dispensed (no. tablets/ pens/patches) <Daily> Dose (including units) Comment ONLY if dose delayed, reduced or altered ____/_____/____ Note: add more rows depending on how IMP is dispensed and Returned RETURNS (add to subsequent visit) Date of Returning IMP dd/mm/yy Quantity Returned (no. tablets/ pens/patches) Comment on compliance ____/_____/____ VISIT X <INSERT VISIT NAME> END OF VISIT CHECKLIST Yes End of Visit Checklist No Have there been any protocol deviations or violations? If yes, please record on the Protocol Deviations Log Is the patient continuing with the study? If not, complete Trial Completion page at end of CRF. Visit completed by: Name SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Signature Date Page 22 of 29 < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name TRIAL COMPLETION Yes, Please provide date of last visit: __ __ / __ __ / 2 0 __ __ Did participant complete the trial? dd/mm/yy No, Please provide date of withdrawal and complete below: __ __ / __ __ / 2 0 __ __ dd/mm/yy Early Withdrawal: please tick most appropriate reason for participant not completing the trial: Adverse Events related: please state related AE: ____________________________________ (add details to AE page) Participant’s decision, specify: __________________________ Investigator’s decision, specify: __________________________ Sponsor’s decision Lost to follow up Patient deceased Other, specify: __________________________ SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 23 of 29 < Short Title/Acronym> Subject/Scre ening No. Patient Initials Site Name CHANGES IN HEALTH LOG Record any changes in health of patient from baseline Changes in current medical conditions/diseases SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Start date Stop date Page 24 of 29 Ongoing Is this change an AE? < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name CONCOMITANT MEDICATIONS LOG Medication Indication Medication start date Medication stop date Ongoing YES/NO Record any medication the patient is taking at baseline or changes to medication from baseline SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 25 of 29 Total dose per frequency marked Unit Route Frequency < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name ADVERSE EVENTS LOG Adverse Event Dates Times if relevant Severity Outcome Actions taken Report any trends in the nature and frequency of AEs to R&D Relationship to study drug Expected or not for study drug Serious Adverse Event SAE requires reporting to R&D on SAE form 1. Start date Start time ___ / ___ / ___ ___ : ___ dd/mm/yy Stop date Stop time ___ / ___ / ___ ___ : ___ dd/mm/yy Study doctor name: Yes Yes No No Signature: Date: 2. Start date Start time ___ / ___ / ___ ___ : ___ Yes Yes No No dd/mm/yy Stop date Stop time ___ / ___ / ___ ___ : ___ dd/mm/yy Severity Outcome Actions taken 1 = Mild 2 = Moderate 3 = Severe 1 = Resolved 2 = Ongoing 1 = None 2 = Therapy prescribed 3 = Study drug interrupted 4 = Discontinued study 5 = Other, specify……………….. SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Study doctor name: Relationship to study drug 1 = Not related 2 = Unlikely to be related 3 = Possibly related 4 = Probably related 5 = Definitely related Signature: If AE is possibly or probably or definitely related to study drug, is AE expected or not for study drug 1 = Expected 2 = Unexpected (not described in SPC, protocol or other product information) Page 26 of 29 Date: Serious adverse event 1 = Resulted in death 2 = Life threatening 3 = Requires hospitalisation 4 = Prolongation of existing hospitalisation 5 = Congenital anomaly/birth defect 6 = Other, specify ……………………………………… Report SAE within 24hrs to R&D on SAE form unless SAE does not need reporting according to the protocol. < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name ADVERSE EVENTS LOG Adverse Event Dates Times if relevant Severity Outcome Actions taken Report any trends in the nature and frequency of AEs to R&D Relationship to study drug Expected or not for study drug Serious Adverse Event SAE requires reporting to R&D on SAE form 3. Start date Start time ___ / ___ / ___ ___ : ___ dd/mm/yy Stop date Stop time ___ / ___ / ___ ___ : ___ dd/mm/yy Study doctor name: Yes Yes No No Signature: Date: 4. Start date Start time ___ / ___ / ___ ___ : ___ Yes Yes No No dd/mm/yy Stop date Stop time ___ / ___ / ___ ___ : ___ dd/mm/yy Severity Outcome Actions taken 1 = Mild 2 = Moderate 3 = Severe 1 = Resolved 2 = Ongoing 1 = None 2 = Therapy prescribed 3 = Study drug interrupted 4 = Discontinued study 5 = Other, specify……………….. SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Study doctor name: Relationship to study drug 1 = Not related 2 = Unlikely to be related 3 = Possibly related 4 = Probably related 5 = Definitely related Signature: If AE is possibly or probably or definitely related to study drug, is AE expected or not for study drug 1 = Expected 2 = Unexpected (not described in SPC, protocol or other product information) Page 27 of 29 Date: Serious adverse event 1 = Resulted in death 2 = Life threatening 3 = Requires hospitalisation 4 = Prolongation of existing hospitalisation 5 = Congenital anomaly/birth defect 6 = Other, specify ……………………………………… Report SAE within 24hrs to R&D on SAE form unless SAE does not need reporting according to the protocol. < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name PROTOCOL DEVIATIONS LOG Protocol deviations are to be taken into account in the study analysis and publication No. Date Protocol Deviation SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Corrective and preventative actions (CAPA) Page 28 of 29 < Short Title/Acronym> Subject/Scre ening No. Site Patient Initials Name CHIEF/PRINICIPAL INVESTIGATOR’S SIGN OFF Chief/Principal Investigator’s Signature Statement I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study information obtained for this participant. All entries were made either by me or by a person under my supervision who has signed the Delegation Log. Chief/Principal Investigator’s Signature __________________________________ Chief/Principal Investigator’s Name Date of Signature __ __/ __ __ / __ __ dd/mm/yy __________________________________ ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS CRF WITHOUT A SIGNED DATA QUERY FORM. SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX Page 29 of 29