Summary of Procedures For The Wellcome Trust Case Control StudyWTT2DM 1) Barcode Allocation The unique barcode number, which is the patient unique study identifier, is supplied by the Biochemistry Department at Ninewells Hospital and is generated by Zebra Barcode One. The label template allocated to the WTT2DM study is NEW7WELL. To ensure every number is unique for each patient, when a request is made to the laboratory for barcode numbers, a list is supplied of numbers already used in the study to avoid duplication. New barcodes numbers that are going to be used on all study documentation and samples are added onto the study database by the study administrator or database programmer. These numbers must be added at this stage otherwise no study data can be added under these barcodes. For accountability purposes, each range of barcodes is entered under the name of the study nurse who will be seeing these patients. 2) Nurse Allocated Community Health Index Number (CHI) At Patient Recruitment Every patient in Tayside is allocated a unique CHI, used in primary/secondary care. This number is in 2 parts: each patients DOB, followed by 4 unique numbers. This 10 figure number constitutes the patient CHI. If the CHI is available at time of recruitment, it is recorded on the study Patient Log. This information is then entered once only on the patient log field in the study database, under the field Nurse Allocated CHI, at the data entry stage. The nurse allocated CHIs are obtained from: Hospital clinic lists originating from TOPAZ-cases Eye screening clinic lists from SCI-DC-cases GP practices when seen out in primary care-cases/controls During telephone recruitment DOB is provided by the patient and the last 4 digits of a patient CHI is available on the reply slip of the patient invitation letter. This number, at the foot of each patients invitation letter is in 3 parts-the practice code, a unique serial number generated by Health Informatics Centre (HIC) and the last 4 digits of each patients CHI provided by Practice Services Division (PSD)-see SOPs 13, 13a and 29 3) Patient Recruitment Details on patient identification and recruitment is described in SOPs 1, 2, 13 13a and 29 4) Study Visit In the WTT2DM study, sequential barcode numbers are allocated to each patient at the study visit. This barcode number is attached to the Patient Log with the patient’s name, address (if a control), and nurse allocated CHI (if available). The patient’s GP is also recorded here. The same barcode number is attached to all study forms, consent, worksheet, questionnaire and biochemistry request form and biochemistry sample bottles, and all blood sample bottles transferred to the Biomedical Research Centre (BRC) for genetic testing and storage. After full written informed consent has been given, a life-style questionnaire is completed, blood pressure is measured, blood samples are taken and BMI and waist measurements are carried out. All documents containing study data are identified by unique barcode only. Patient consents are stored with Patient Logs (identifiable data) at time of archiving, separately from any anonymous study data. See SOPs 3-12, for details of study procedures done. 5) Data Entry After recruitment, all study forms are transported to data entry personnel at the Clinical Information Bureau (CIB). After single data entry of all data, including patient identifiers on the patient log – all paper documents are returned to the study administrator. Any identifiable data is password protected and only available to the study team-research nurses, study administrator, data entry and data management. Refer to SOP 17 6) Research Blood Samples Blood samples collected for genetic testing are transported to the Biomedical Research Laboratory in Ninewells Hospital identified by the unique barcode number only. See SOPs 9, 28 and 31 for details of procedures carried out for sample preparation, storage and transportation 7) Biochemistry blood samples and transfer Biochemistry samples are taken to the biochemistry laboratory at Ninewells Hospital, identified by the unique barcode. The sample request form has the same barcode number and, in addition, records the patient name and date of birth. In order for Biochemistry to link the correct patient with the correct existing CHI for that patient, the request form must have a correct name, date of birth and either patient address or nurse allocated CHI. Without these correct details, biochemistry will not allocate the patient CHI. The study team is contacted by the laboratory for any clarification required. It is the responsibility of the study nurses to resolve any issues and feed back to the laboratory so that the sample can be processed. A sample will be discarded if incorrectly labelled i.e. no bar code label, incorrect DOB. In these cases a duplicate sample may be obtained from Biomedical Research Centre. This sample can be re-sent to the laboratory under the same bar code. Occasionally a patient can have 2 different CHIs but these are linked together on the SCI-Store system and are recognised as the same patient there. The laboratory have their own SOP detailing procedures followed if there is a discrepancy with the information provided-Dealing With Non Positive ID Requests. In order for automatic data transfer of biochemistry readings to occur there must be a CHI allocated by Biochemistry. The biochemistry results are picked up from SCI-Store through the unique barcode identifier and periodically transferred over to the WTT2DM study database. 8) Quality Control (QC) Checks All source documents (paper study forms), once returned from the data entry team to the study administrator, are manually checked against the data entered in the database. Any discrepancies are recorded and resolved by the study administrator and study research nurses. In addition, QC checks are generated automatically through set parameters on the database and resolved regularly – see list of QC checks.and SOP 24Biochemistry values will not transfer to the study database without a valid CHI. QC checks by study administrator and nurses will ensure laboratory allocated CHI matches the date of birth and nurse allocated CHI (when available). The study database has hard data checks which ensure out of range data, including invalid CHIs, cannot be entered. List of QC checks: Barcodes for patients missing their Fasted information Barcodes for patients missing their Case/Control information Barcodes for patients missing their Date of Birth information Barcodes for patients who have a Diabetes Type but not a Treatment Present smoker missing Present smoker but no amount presently smoked Amount presently smoked when not currently smoking Past smoker missing Past smoker but no amount past smoked Amount past smoked when not a past smoker Age started smoking but neither past nor present smoker Periods stopped but no age Periods stopped missing but age periods stopped present Periods stopped but no natural or medical choice made Work Recently Missing Work Past Missing Work Youth Missing Travel Recently Missing Travel Past Missing Travel Youth Missing Leisure Recently Missing Leisure Past Missing Leisure Youth Missing Sex Missing Consent Date not the same as Biochemistry Date Consent Date out of range Biochemistry Date out of range Date of Birth out of range Date of Birth not matching CHI (in either Day, Month or Year) Age out of range 16-100 Biochem CHI not matching Nurse CHI Glucose value missing for fasted control Date Collected but missing some Biochemistry values Control Letter sent but not uploaded GP Control Letter sent but not uploaded Control Biochemistry in but no letter sent Control Biochemistry in but no GP letter sent No Biochem 10 Days after Participant Date from Consent Form Biochem Date but no Biochem CHI No Letter Sent to Control 3 Weeks After Consent No Letter Sent to Control GP 3 Weeks After Consent Male Participant with Menopause History Waist Missing Height Missing Systolic or Diastolic Reading 1 Missing Systolic or Diastolic Reading 2 Missing Heart Rate 1 Missing Heart Rate 2 Missing Weight Missing Screened At Missing (Control) Recruited By Missing Difference between Sampled and Fasted <4 Or >20 hours Sampled or Fasted missing from 18/06/07 Sex recorded does not match CHI 9) Letter Generation Every control patient taking part in the study receives a letter detailing basic results - blood pressure, BMI, cholesterol, HDL/LDL, triglycerides, creatinine and HbA1c together with a note of thanks from the study physician. These results are compared with set parameters for the respective values and any clinically abnormal readings highlighted. A normal or abnormal letter is generated from the database by the study nurse or administrator and reviewed by the study physician. The Absolute Risk Factor is calculated automatically, using the Framingham Score. See SOP 15 and 16 The study physician reviews and signs the result letters to control participants and a copy is sent to participants GPs. If there are any abnormal values these are highlighted on the letter and patients are advised to visit their GP within 6 weeks. Letters will not be generated without a full biochemistry CHI on the database. Any clinically abnormal results will be followed up by the patients’ GPs The database allows the study nurse to review any abnormal results of cases where routine blood samples are not being taken at time of recruitment e.g. when recruited at eye screening. Any significantly abnormal results for that patient will be reported back to the practice by the study nurse by phone, email or letter to GP or practice nurse. 10) Archiving Study data and patient identifiers are stored separately prior to archiving. Consents and patient logs are separated from study data. Names, CHIs and dates of birth are removed from all biochemistry printouts and result letters so that results are only identifiable by their barcode number. Archive boxes are clearly numbered and a list kept to ensure accurate recall if necessary. The archive facility is Iron Mountain. See SOP 14 11) WTT2DM Database The study dataset is managed by the HIC based at the University of Dundee within Ninewells Hospital. At the end of the data gathering phase, when all the QC checks are complete, the database will be anonymised to all users The SOP The Management of HIC Datasets (http://www.dundee.ac.uk/hic/data/HICSOP/) describes the management of all HIC datasets including anonymisation, data release, reversing the anonymisation process and archiving.