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Download CRF case report form - Sheffield Teaching Hospital
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Sheffield Teaching Hospitals NHS Foundation Trust Research Department Generic Case Report Form Completion Guidelines General Instructions Abbreviations CRF NK ND NA NAD AE SAE case report form not known not done not applicable no abnormalities detected adverse event serious adverse event General guidance Always refer to the study protocol before completing forms. The CRF must always be completed by authorised site personnel. If you are new to a trial, make sure you have completed the delegation form in the site file. Ensure data entries are consistent with the source data (usually the patients medical record) Always use black ballpoint ink Always write clearly ensuring that the entries are legible to others Avoid abbreviations and acronyms, unless they are standard medical abbreviations or known to be acceptable. Ensure that you complete the ‘header’ information on each page consistently. Always fill in EVERY field on each CRF page (unless indicated otherwise). If a procedure was not done or not applicable, enter ND or NA where appropriate. Do not write outside of the designated boxes. Write comments on the comments page. Completely fill in each box using leading ‘0’ if needed. To amend incorrect data on a CRF page, score through the error with a single line, do not obscure the original entry (do not use correction fluid), write the correct data nearby, initial and date each amendment. Do not record incomplete dates (i.e. if you know the month and year, but not the day, record- NK/04/05). Record dates in the requested format (i.e 11/04/05; 11 APR 05; 11 APR 2005) Ensure you use the correct units for weight, height, lab results etc Ensure AE’s are consistent through visits (if required). If they are new at cycle 1, but continue through cycle 2, make sure it is documented at cycle 2 as well. If a medication was given for an adverse event, make sure it is documented as fully as possible. For tumour assessment pages, make sure tumours are documented consistently- in the same order at each assessment. If a lesion has disappeared between assessments, record them on the page as ‘not present’. Check that assessment has been carried out by the same method (CT, physical, MRI etc). Ensure that all CRF pages are signed and dated by the person completing the form. D:\582749119.doc Page 1 of 7 Page Specific Instructions Header information- all pages Field Trial Number Subject Initials Comments STH project number If 2 initials, use dash Subject number Enter patient number Consistency check Check correct study Not blank, check consistency Not blank, check consistency Baseline Demographics Field Visit Date Sex Date of Birth Age Height Weight BSA Race BMI Smoker BP Pulse Temperature Route Alcohol use Inclusion criteria met Exclusion criteria met Date of Informed consent Comments Dd/mmm/yy Circle Dd/mmm/yy Whole years Metric (cm) Metric (kg) Body Surface Area (sq. m) Text Metric Circle/ how many per day/ type Systolic/diastolic mm/hg Beats/minute Celsius Circle Units/week Should be yes to continue Should be no to continue Dd/mmm/yy- date patient signs consent form Person completing the form Consistency check Visit on/after consent date Not blank Not blank Not blank Correct format Correct format Check correct Not blank Check correct If yes, amount completed Correct format Correct format Correct format Not blank Not blank Must be yes Must be no Date on/ before visit date Field No Condition/illness/surgical procedure Start date Comments Number of event Describe fully Consistency Check Line number sequential Fully described Dd/mmm/yy Ongoing Tick if ongoing End date Dd/mmm/yy Medication taken Y/N- if yes, enter on con meds page Signature Person completing the form Must be before consent date If yes, end date should be blank If ongoing blank, must have and end date If yes, check con med page for matching medication Signed Signature signed Past Medical History Sheffield Teaching Hospitals NHS Foundation Trust Research Department Vital Signs Field Visit date Time BP Pulse Temperature Route Signature Comments DD/mmm/yy 24 hour clock- time of assessment Systolic/diastolic mm/hg Beats/minute Celsius Circle Person completing the form Consistency check Check date within protocol timeframe Not blank Correct format Correct format Correct format Not blank Signed Physical Examination Field Visit date Comments Dd/mmm/yy Visit number Exam date Dd/mmm/yy day exam performed Exam performed by General Qualified person- on delegation list Circle and comment if abnormal Head/neck/ENT Circle and comment if abnormal Cardiovascular Circle and comment if abnormal Musculo-skeletal Circle and comment if abnormal CNS Circle and comment if abnormal Respiratory Circle and comment if abnormal Dermatological Circle and comment if abnormal Gastro-intestinal Circle and comment if abnormal Genito-urinary Circle and comment if abnormal Blank- complete if others performed Signature Circle and comment if abnormal D:\582749119.doc Page 3 of 7 Person completing form Consistency check Check date within protocol timeframe Sequential visit dates completed Check date within protocol timeframe- can be different from visit date Check delegation list If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered Signed Haematology Field Visit date Comment Dd/mmm/yy Visit number Sample date Dd/mmm/yy Sample time Laboratory name Time of collection Ensure reference ranges are in site file or present in source data g/dl 109/L 109/L 1012/L l/l Haemoglobin WBC Platelets RBC HCT Neutrophils Lymphocytes Monocytes Eosinophils Basophils BlankSignature Complete if others carried out Person completing the form Consistency Check Check date within protocol timeframe Sequential visit dates completed Check date within protocol timeframe- can be different from visit date Not blank Check reference ranges present Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Signed Chemistry Field Visit date Comment Dd/mmm/yy Visit number Sample date Dd/mmm/yy Sample time Laboratory name Time of collection Ensure reference ranges are in site file or present in source data Mmol/L Mmol/L Mmol/L Mmol/L Mmol/L Mmol/L g/L g/L Mmol/L Mmol/L Umol/L IU/L IU/L IU/L IU/L Person completing form Sodium Potassium Urea Creatinine Bicarbonate Chloride Total protein Albumin Calcium Adj Calcium Total bilirubin Alk. Phos. AST ALT GGT Signature Consistency check Check date within protocol timeframe Sequential visit dates completed Check date within protocol timeframe- can be different from visit date Not blank Check reference ranges present Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Signed Sheffield Teaching Hospitals NHS Foundation Trust Research Department Immunology Field Visit date Comments Dd/mmm/yy Visit number Sample date Dd/mmm/yy Sample time Laboratory name Time of collection Ensure reference ranges are in site file or present in source data Complete as appropriate Person completing form Blank Signature Consistency Check Check date within protocol timeframe Sequential visit dates completed Check date within protocol timeframe- can be different from visit date Not blank Check reference ranges present Not blank Signed Urinalysis Field Visit date Comments Dd/mmm/yy Visit number Sample date Dd/mmm/yy Sample time Laboratory name Time of collection Ensure reference ranges are in site file or present in source data Glucose Bilirubin Ketones Spec. gravity Blood pH Protein Urobilinogen Nitrite Leucocytes Blank Pregnancy Signature D:\582749119.doc Page 5 of 7 Complete as appropriate Circle Person completing form Consistency check Check date within protocol timeframe Sequential visit dates completed Check date within protocol timeframe- can be different from visit date Not blank Check reference ranges present Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Not blank Signed Investigations Field Visit date Comments Dd/mmm/yy Visit number Sample date Dd/mmm/yy Sample time ECG Time of collection Circle and comment if abnormal Xray Circle and comment if abnormal CT scan Circle and comment if abnormal MRI scan Circle and comment if abnormal PET scan Circle and comment if abnormal Dexa scan Circle and comment if abnormal Doppler Circle and comment if abnormal Ultrasound Circle and comment if abnormal Blank Complete as appropriate Signature Person completing from Consistency check Check date within protocol timeframe Sequential visit dates completed Check date within protocol timeframe- can be different from visit date Not blank If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered If abnormal- check comment entered Signed Comments Field Comments Dd/mmm/yy Date comment refers to Comment refers to specific page Keep comment brief Person completing form Consistency check Check date ties up Field CM No Medication Indication Route Dose/unit Frequency Prophylaxis Start date Ongoing End date Comments Line number of medication Generic name Condition/event Enter relevant code Total dose/day Enter relevant code Yes or No Dd/mmm/yy Tick if ongoing Dd/mmm/yy Related AE no If taken for adverse event, document which one Person completing form Consistency check Line number sequential generic term used correct indication Route correct Dose correct Frequency correct If Yes, no AE needed After entry onto study If yes, no end date If ongoing= no, end date required If AE, check AE page for matching entry signed Date Relevant page Comment Signature Check page ties up Check legibility Signed Concomitant Medications Signature Sheffield Teaching Hospitals NHS Foundation Trust Research Department Adverse Events Field AE No Event Name System Start date Ongoing End date Intensity Relation to stud drug Study drug action Outcome Serious? Signature D:\582749119.doc Page 7 of 7 Comment Line number of event Describe condition rather than symptoms Enter relevant code Dd/mmm/yy Tick if ongoing Dd/mmm/yy Enter relevant code Enter relevant code Enter relevant code Enter relevant code Yes/ No if yes complete SAE report form Person completing form Consistency check Line number sequential Condition entered not symptoms Not blank After entry onto study If yes, no end date If ongoing = no, end date required Not blank Not blank Not blank Not blank If yes, SAE reported? Signed
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