Entering Patient Data int the SDRN/ SCI-Diabetes Research Register Clinical S.O.P. N.: 25 Versin 2.0 Cmpiled by: Apprved by: Review date: Nvember 2016
Entering Patient Data int the SDRN/SCI-Diabetes S.O.P. N. 25 Research Register Versin 2.0 DOCUMENT HISTORY Versin Detail f purpse / change Authr / edited Date edited number by 1.0 New SOP Luise Greig / Paul McIntsh / Shna Brearley 1.1 Minr change t SOP title Luise Greig June 2012 2.0 Changes made t reflect the use f the Research Register leaflet and updates t SCI-Diabetes, Jhn Kerr May 2013 All SDRN SOPs can nw be dwnladed frm: http://www.sdrn.rg.uk/?q=nde/45 2 f 6
Entering Patient Data int the SDRN/SCI-Diabetes S.O.P. N. 25 Research Register Versin 2.0 1. Intrductin ICH GCP States that Systems with prcedures that assure the quality f every aspect f the trial shuld be implemented. This SOP details the prcedure t be used. 2. Backgrund The Research Register is a natinal SDRN initiative set up t give peple with diabetes the pprtunity t sign up t a register that allws research staff t cntact them abut research prjects with a view t participating in them. (The Research Register leaflet cntains the registratin frm and shws that the patient has had the pprtunity t vlunteer t be apprached abut research studies). 3. Objectives T describe the steps that shuld t be fllwed by the individual entering data nt the SDRN functin in SCI-Diabetes and hw t prcess the Research Register dcumentatin. 4. Prcedure The fllwing describes the prcess fr entering patient details int the SDRN/SCI-Diabetes Research Register. Please refer t SDRN/SCI-Diabetes Research Register Data Entry User Guide (APPENDIX 1) at the end f this SOP fr a step-by-step guide t the pages yu will see thrughut the whle data entry prcess - Please nte it is necessary t enter all respnses Yes and N int the SDRN/SCI- Diabetes Research Register. The SDRN Research Register pages f SCI-Diabetes are restricted t specific staff. In rder t access the SDRN Permissin t Cntact pages f SCI-Diabetes yu will have t make a request t the SDRN Office by email (admin@sdrn.rg.uk) r telephne. Once yu have been granted access yu can lgin frm the main SCI-Diabetes System Lgin page t access the SDRN/SCI-Diabetes Research Register pages. Once yu have lgged in yu shuld select the Main Menu ptin n the left-hand side f the tlbar wherein yu can navigate t SDRN Admin befre clicking n Find and Select a Patient. All SDRN SOPs can nw be dwnladed frm: http://www.sdrn.rg.uk/?q=nde/45 3 f 6
Entering Patient Data int the SDRN/SCI-Diabetes S.O.P. N. 25 Research Register Versin 2.0 Yu can nw search fr a specific patient s details using the CHI r Surname, Date f Birth and/r Pstcde (r a cmbinatin f the three). This infrmatin can be btained frm a cmpleted Research Register leaflet frm. Once yu have entered the relevant infrmatin int the apprpriate fields click n the Search buttn t return the Patient List. (If a patient s details cannt be fund by using the CHI r Surname and D.O.B. then please highlight the name n the white spreadsheet and a member f the SDRN Administratin team will carry ut a search at a later date and enter the details. If yu require a cpy f the white spreadsheet please cntact the SDRN Office by telephne r email (admin@sdrn.rg.uk). Alternatively, make a nte detailing the patient/s that cannt be fund and return this with the cmpleted Research Register leaflet frms. The Patient List will display the results f yur search and yu shuld be able t match the D.O.B. with the name f the patient fr whm yu are searching. T select a patient, place the cursr ver the patient infrmatin. The patient details will then be highlighted in red. Click n the highlighted line t select the patient. When the Patient has been selected, the Manage Patient Cnsent page will be displayed and yu shuld nw prceed t cmplete the relevant fields. If the patient is t be added t the register: Enter the patient s telephne number and/r email (if prvided) int the apprpriate field(s). Prceed t the Recrding Cnsent sectin and click each sectin as apprpriate. Prceed t the Patient Preferences sectin and click each sectin as apprpriate befre selecting the patient s preferred methd f cntact. If several methds f cntact have been indicated, and this includes telephne, select telephne as the preferred methd f cntact. If the preferred methd f cntact is unclear then letter has t be selected as the methd f cntact. (Our preferred default rder is 1. Phne, 2. Email, 3. Letter.) When the crrect data has been entered click Save. (Click Reset if yu want t edit r revise the infrmatin.) Yu will nw be redirected t the Find and Select a Patient screen where yu can begin t enter the details f anther patient r exit/lg-ut the system. Once yu have entered a patient s details int the system please make a recrd f this n the white spreadsheet by placing a tick in the relevant bx next t their name. All SDRN SOPs can nw be dwnladed frm: http://www.sdrn.rg.uk/?q=nde/45 4 f 6
Entering Patient Data int the SDRN/SCI-Diabetes S.O.P. N. 25 Research Register Versin 2.0 The fllwing prvides guidance n hw t Prcess the Research Register dcumentatin - Start a new white spreadsheet every mnth and all patients shuld be entered nt the spreadsheet in date rder. Cllate the cmpleted Research Register leaflets in the rder patients are listed n the white spreadsheet(s). When string patient identifiable data (PID) held n paper (i.e. Cmpleted Spreadsheets & Research Register leaflets) must be securely stred in lcked filing cabinets within secure ffices/areas. Return the cmpleted Research Register leaflets and the white spreadsheets t the SDRN central ffice n the 1st day f every mnth. When returning cmpleted Research Register Spreadsheets & cmpleted Research Register leaflets t the SDRN, please make sure the package is securely taped t prevent the cntents frm mving in transit and tearing the envelpes/ packaging. It is required t be duble wrapped in stut envelpes/packaging with recipient and sender name and address written/printed n bth layers. Envelpes/packages must be sent by Ryal Mail Special Delivery r a similar signed fr service. (Fr further details f SDRN PID Prcedures please see SOP 26 - SDRN & Persnal Identifiable Data (PID) in Clinical Use) N cpies f the Research Register spreadsheets r the cmpleted Research Register leaflets are t be retained at the site/hspital/clinic where the patients jined the register. Address fr returns Administratr Scttish Diabetes Research Netwrk SDRN Office Diabetes Supprt Unit Level 8 Ninewells Hspital Dundee DD1 9SY All SDRN SOPs can nw be dwnladed frm: http://www.sdrn.rg.uk/?q=nde/45 5 f 6
Entering Patient Data int the SDRN/SCI-Diabetes S.O.P. N. 25 Research Register Versin 2.0 (APPENDIX 1) SDRN/SCI-Diabetes Research Register Data Entry User Guide Versin 2.0 All SDRN SOPs can nw be dwnladed frm: http://www.sdrn.rg.uk/?q=nde/45 6 f 6