CVDMC User manual - Cardiovascular Data Management Centre
Contents
1. 2013 09 27 OPCAB TGH Section 2 Figure 2 2 5 Show all surgeries for this patient While only one shows in this example if this patient had multiple surgeries they would all be listed chronologically by date from newest to oldest Next we need to update the follow up information for this patient as an interaction has occurred between the patient and his doctor and or surgeon Navigation to the Follow up database If you have access to this module it will be visible after the surgery module on the navigational panel and will look like this Link to Followup Current status Unknown Date of last contact None Update Note to users date of last contact should be verified and updated if necessary every time the record is accessed Date of last clinical follow up None Update new clinical followup Section 2 Figure 2 2 6 Followup module with no data entered Before performing any operations with this module verify that you have the following data as all three fields will be required e The patients current status aka are they still alive Are they dead WV DM C yy Official release 2013 12 20 Page 21 of 39 e What was the date that the patient was last contacted e What was the date of their last clinical follow up Once all three of these data points have been verified click on update to proceed to the REDCap screen where you will enter the patients follow up details Make sure to copy and paste the P2. UNIVERSITY OF TORONTO CARDIOVASCULAR DATA MANAGEMENT CENTRE USER MANUAL OFFICIAL RELEASE 2013 12 20 Contents 6 Eee oe een en ea ee a 3 Project general describit can dnea sade REE ect 3 CEOS cca E E 3 Pabts Or the WIOLC VDE 4 Section 1 Applications ANd ACCESS 4 Section 1 1 Requesting a UTorCVDb REDCap 6 Section 1 2 Requesting database MOUle 655 8 Section 1 3 Requesting database changes REDCap Online ccccccssccecesecscenececeneceeeneeseeueceeeneceeensss 9 Section 1 4 REQUESTING password recovery cccceeccecccecceeeeceensecenceeeuceeeeceeenceeeuceeeeeeeeeeseueeeeeeceeeseeneets 10 Section 1 5 Requesting password ESE 12 Section 1 6 User account deletion and 6 55 13 Section 2 Database
3. CRF DCI 1 CRF DCI 2 CRF DCI 3 Section 1 Section 2 Section 3 Field variable 1 Field variable 2 Field variable 3 Official release 2013 12 20 Page 30 of 39 Section 3 Data entry Section 3 1 REDCap web interface main window The frontend interface panel see figure below is divided in the following manner Brief overview of the sections is given below Project home Takes you to the home screen of a particular database module This home screen will have the following subsections Quick tasks shortcut to database module applications User list the current users of the database module Project statistics summary of the database module Calendar events only applicable to selected users Record status dashboard Using legend this dashboard will list the current status of every form in the database of all patients Data collection instruments Lists all the CRFs forms available in the database Depending on the user level access some CRFs may not be visible to all end users Help amp Information FAQs and vide tutorials on REDCap can be found here Official release 2013 12 20 Page 31 of 39 UofTCVDb Main REDCap Logged in as tanveer collins Logout 8 My Projects Project Home E Project Setup Project status Development Data Collection 7 Edt instruments Record Status Dashboard View data collection status of all records 5 Add Edit Records am
4. If you don t see the record for your patient click on Search for another patient and try searching using another item of that patients data Note If multiple results are found when searching for either an OHIP number or an MRN number please contact either your manager or Cvdmc requests sickkids ca immediately This would bring us to the end of usage instructions for ONCOA Section 2 2 NavPanel Before we begin e Do you have a REDCAP login This would have been to you by SickKids Cvdmc requests sickkids ca or by your manager Verify that you have it before continuing the module will be inaccessible without it e Do you have a valid ONCOA id Normally this will be part of the URL that will take you to the patient s navigational panel but you will need to cut and paste it into the REDCap database more than once so it s good to make sure you have it e Records that you ll need to enter into REDCap Kind of a given but it never hurts to verify GY DM C Ne Official release 2013 12 20 Page 17 of 39 e Verify that there is not a pop up blocker in place for the browser that you are If unsure contact your IT department to verify With these items verified check to see that you have the following screen displayed as shown in Figure 2 2 1 REDCap Log In Please log in with your user name and password If you are having trouble logging in please contact Chris Reed Username creed Password eess
5. and publication support Gy D M C ATA 9 Official release 2013 12 20 Page 3 of 39 Parts of the UTorCVDb User Manual This user manual is divided into the following sections 1 Section 1 Applications and access control 2 Section 2 Database structure 3 Section 3 Data entry Section 1 Applications and access control The instructions to fill out the CVDMC applications to access databases are described in sections e Section 1 1 User account request for new users only e Section 1 2 Requesting database module access e Section 1 3 Requesting database changes e Section 1 4 Requesting password recovery e Section 1 5 Requesting password reset e Section 1 6 User account deletion User accounts to both the ONCOA software and the REDCap web interface are provided only on a need to know basis and level of access as described in the security matrix below is tailored to the role and function of each applicant As part of the user account application process a justification of the level of access requested will be required CVDMC security matrix next page Gy D M C Official release 2013 12 20 Page 4 of 39 Directors executive and managing Database managers programmers Data clerks administrative assistants Contributing sites Chief of Division RC Backend ONCOA Backend RC record deletion RC Data entry ONCOA Data entry RC record locking RC report generation RC data exp
6. Section 1 Figure 1 4 2 REDCap password recovery temporary password in email Set Your Password Your password has not been Set yet or has been reset You will need to set your password here to whatever value you wish Please enter your desired password below and click the Submit button Once your password has been set you may use it with your user name whenever you log in to any REDCap project Please make sure that you write down or remember your new password for future use The password must contain only letters numbers and underscores and it must consist of at least one lower case letter one upper case letter and one number Username Password Re type password Password Changed Your password has now been changed You may now click the button below to navigate back to REDCap Continue gt gt Section 1 Figure 1 4 3 REDCap password recovery logging back following a password recovery Rh3K 9r DE a2 DMC 6e JPHQ3a TM oes Official release 2013 12 20 Page 11 of 39 Section 1 5 Requesting password reset Password reset for REDCap account is left to user s discretion REDCap password won t expire except in circumstances where the account may be deleted by CVDMC administrators see section 1 6 for details CVDMC recommends password reset at regular intervals to ensure user account security In order to edit your profile navigate to the my profile window from user home page and click r
7. incomplete Records 1 iz Z Add Edit Records Unverified Records 0 select record Sr ESE Complete Records 0 select record x Preop History Preop Cardiac Status Add new record OR Common OR CAB OR Valve Surgery OR Mech Cardiac Assist Devices OR Other Cardiac Procedures Data Search Postop peacocks ere canes select search field 5 58 Ga Calendar Search query Data Export Tool Begin typing to search the project lice Data Import Tool the list to navigate to that record Data Comparison Tool Logging File Repository NOTICE amp User Rights This project is currently in Development status Real data should NOT be entered until the amp Record Locking Customization project has been moved to Production status ZA E signature and Locking Mgmt 2 Graphical Data View amp Stats Data Quality E Report Builder Section 3 Figure 3 2 1 REDCap interface Add select record window You may wish to update an existing record or create a new record As in the figure above you have four options to enter data 1 Updating an incomplete or unverified record by selecting the record from the drop down box as seen in 1 below 2 Updating a complete record by selecting the record from the dropdown box as seen in 2 below 3 Entering a specific record number in 3 below to update the record 4 Entering a new record number Study ID in 3 below If an already existing s
8. match The application will route you to a form to enter the patient s data that you re searching for See Figure 2 1 3 for an example Multiple results were found When searching for the particular patient OHIP number MRN number or last name multiple matches of what you were searching for were discovered The application will route you to a screen where you can compare the discovered data and click on the patient that matches the ones that you re searching for See Figure 2 1 4 for an example Note If multiple results are found when searching for either an OHIP number or an MRN number please contact either your manager or Cvdmc requests sickkids ca immediately A matching record was found When searching for the particular patient OHIP number MRN number or last name there was a match The application will then route you to the main page of the navPanel module within REDCap See Figure 2 2 1 for an example Official release 2013 12 20 Page 15 of 39 Enter a new patient All fields are required unless otherwise indicated For out of province patients if there is any indication that this patient has had a previous cardiac intervention at any other Toronto hospital please contact CVDMC before creating anew ID OHIP Leave blank if out of province MRN Date of Birth Dates in YYYY MM DD format First name Last name Create ID Section 2 Figure 2 1 3 Entering a new patient record Here you see
9. record for the patient being viewed and to allow you to access the Hearts and Minds navigation panel Heart amp Minds clinic record H s and Minds navigation panel Section 2 Figure 2 2 12 Hearts and minds entry with no record for patient To add a record into the Hearts and Minds database you will need to add both a patient record and an assessment record or just an assessment record if the patient record has already been entered in the following screen NAVIGATION TO UTorCVDb MODULES Patient ID 54 c867e6e4226bb840782bcf2868b05cd1e3cb5a3a7777080238d52e1634091 c Note to user the information included in this navigation panel gives a summary of the data holding for this given patients across the CVDMC environment Access to detailed data is restricted by institution For queries regarding cross institutional data access please contact the CVDMC at cvdmc requests sickkids ca or CVDMC help desk at 416 813 7654 x 228304 Navigation panel for Heart amp Mind clinic Date of last H amp M clinic assessment None Date of last update of patient level data None Add Patient Data Section 2 Figure 2 2 13 Hearts and Minds main Panel Official release 2013 12 20 Page 24 of 39 lf Date of last update of patient level data is set to None click on Add Patient Data This will take you to a screen that will allow you to enter patient related data for the patient in question Make sure to copy and paste the Patient Id
10. required Section 1 1 Requesting a UTorCVDb REDCap user account Form required UTorCVDb user account request Format fillable pdf Needed for Currently not holding a REDCap account but needs potential access to University of Toronto cardiovascular database UTorCVDb Form fields 11 1 First name Last name Institution select one e Sunnybrook Hospital St Michael s Hospital e The Hospital for Sick Children e Toronto General Hospital Clinical division e Cardiology Cardiovascular surgery e Critical care medicine cardiac e Diagnostic image e Other enter text Position select one or type in Employee number Module request and level of access within the CVDMC Select all that apply Navigation STS cardiac surgery Cardiology ECHO Hearts amp Minds Clinic Biobank 8 Do you have an existing REDCap account 9 Requestor s name printed 10 Requestor s signature 11 Requestor s email This email will be used for all your future CVDMC correspondence 12 Date of signature requestor 13 Division chief s signature 14 Date of signature chief of division Please scan and email the completed form to CVDMC requests sickkids ca A validation email with a temporary password will be sent to the email address you provided Click on the link in the validation email and log in using the user name and the temporary password provided in the email Once you log in using your temporary password set up your new passwor
11. the form to add a new patient data record into ONCOA Please endeavor to enter as much information as possible as it will aid positive identification if there are multiple records with similar matching fields especially last name Once complete click on Create ID to have ONCOA validate the form and if everything matches the program will route you to the main page of the navPanel module within REDCap See Figure 2 1 4 for an example If the OHIP or MRN number isn t matching the specified format or the date of birth isn t in the specified format the program will return with an error and ask you to try again Official release 2013 12 20 Page 16 of 39 There are multiple records that match your search Please select from the list below First name Last name DOB MRN OHIP Toe Smith 1955 12 12 123123123 123123123AA John Smith 1955 12 12 234234234 234234234WW Search for another patient Section 2 Figure 2 1 4 Selecting from multiple patient records Here you see the form that if multiple matches were found they will be displayed with all of their particular data in a chart form This will allow you to make an easier identification of which record if any matches your current patient If you see the record that matches your patient s data click on the link in their first name and the application will route you to the main page of the navPanel module within REDCap See Figure 2 2 1 for an example
12. up note Official release 2013 12 20 Page 35 of 39 Section 3 5 Data entry field types The following figure below illustrates an example of a data entry form The data type for each field determines the appearance of the field There are several field types in REDCap Checkbox lists Select all answers that apply Slider analog scale Set response by dragging a bar on the scale File upload To upload file e g scanned image or pdf file Calculated fields Calculated fields are automatically populated based on data of one or more field values For example subject s age could be calculated by subtracting the date of birth from a date provided at the baseline visit Adding new Participant ID 1 Peery Third answer Participant ID 1 NEW SECTION 1 Date Today D First answer Radio buttons D Second answer J Third answer LTITTTITTITILILILILILI LILI reset Drop down list First answer i Second answer NEW SECTION 2 Firstanswer Checkbox check all that apply Second answer Third answer i 7 low medium i Slide visual analog scale a Click bar above and then drag to set response a reset Calculated field View equation File upload link Upload document Notes box Form Status Complete Incomplete Section 3 Figure 3 5 1 Data entry field types Official release 2013 12 20 Page 36 of 39 Alternatively you can get a brief overview of the data field types from the RED
13. with records locking unlocking privileges Record correction can be necessary in the case of a data entry mistake not previously identified through the CVDMC mechanisms or because of a request for correction of personal health information at the participating institution level Accuracy of personal health information is the responsibility of the submitting site Sites are required to respond to personal health information requests and make appropriate corrections if necessary as per standard hospital policies CVDMC must be informed of any such corrections inasmuch as it affects data previously submitted to the REDCap web interface and locked by a CVDMC administrator Section 3 8 Data security and privacy violation Every end user will need to complete training on ethics and protection of personal health information as applicable at each institution If a security violation is discovered or occurs whether associated with the REDCap web interface or the ONCOA software whether it happens at the end user level or central CVDMC administration it should be reported immediately to the CVDMC cvmdc requests sickkids ca or 416 813 7654x228304 and CVDMC Managing Director cedric manlhiot sickkids ca CVDMC will notify the SickKids Privacy Office privacy office sickkids ca or 416 813 7474 and the privacy offices of the other concerned institutions if any as soon as possible Furthermore CVDMC will review and assess the situation The CVDMC will work wi
14. Cap HELP panel Section 3 6 Saving forms Please note that there is no auto save in REDCap Once you have completed entering the information on a form you MUST click one of the save option buttons at the bottom of the screen or in the floating box The Form Status section will allow you to identify if the record is incomplete unverified or complete Study ID skl0009 Data Collection Instruments Demographics e Month 1 Data Month 2 Data Month 3 Data Completion Data Applications Calendar C3 Data Export Tool Data Import Tool L gt Data Comparison Tool Logging File Repository amp user Rights IA Graphical Data View amp Stats Report Builder Reports 1 Records Status 2 Demo Report Help amp Information S Help amp FAQ a Video Tutorials Suggest a New Feature If you are experiencing problems please contact your REDCap administrator amp Editing existing Study ID skio009 Study ID Baseline Measurements Date of baseline visit Date blood was drawn Serum Albumin g dL Serum Prealbumin mg dL Creatinine mg dL Normalized Protein Catabolic Rate g kg d Cholesterol mg dL Transferrin mg dL Kt Dry weight kilograms Collected Plasma 1 Collected Plasma 2 Collected Plasma 3 Collected Serum 1 Collected Serum 2 Collected Serum 3 Subject Global Assessment score 1 7 Date patient begins supplement Form Status Complet
15. Example Database Month 1 Data Editing existing Study ID 12 Study ID Month 1 Date of Month 1 visit Serum Albumin g dL Serum Prealbumin mg dL Creatinine mg dL Normalized Protein Catabolic Rate g kg d Cholesterol mg dL Transferrin mg dL KUV Dry weight kilograms Number of treatments missed How compliant was the patient in drinking the supplement Hospitalization Data Was patient hospitalized since last visit What was the cause of hospitalization Date of hospital admission Date of hospital discharge Discharge summary in patients binder Mortality Data Has patient died since last visit Date of death What was the cause of death Form Status Complete 19 VIDEO Basic data entry 16 min BD Download POF of select PDF download option x 2 Today p E Today w oe incomplete Save Record Save and Continue Save and go to Next Form Section 3 Figure 3 3 1 Navigation across CRFs The colored dots beside each CRF represent the status of the form completeness legend red incomplete yellow unverified green complete To navigate a different study ID click on select other record from the left panel and this will take you to the initial window to enter another ID Official release 2013 12 20 Page 34 of 39 Section 3 4 Data entry validation Enter a value in the data fie
16. Re operations Yes No reset Form Status Complete Incomplete A Modify this instrument VIDEO Basic data entry 16 min pS Download PDF of select PDF download option 1 PATIENT STATUS Please enter the ONCOA generated ID Alive Died late death Lost to follow up reset If death put date and primary cause of death below Section 2 Figure 2 2 9 Clinical followup REDCap form As you can see there s a lot more information to enter Don t forget to copy and paste the patient ID into the proper field Navigation to the Biobank database If you have permissions to view this module it will show as the third section of the navigation panel and upon patient creation look like this Link to Biobank Sample available in biobank No Section 2 Figure 2 2 10 Biobank module with no sample If the patient has a biobank entry the complete record will look as such Official release 2013 12 20 Page 23 of 39 Link to Biobank Sample available in biobank Yes Sample Inventory Record Institution holding sample TGH Section 2 Figure 2 2 11 Biobank record with sample data Where depending on your permissions you can see where this entry is located and its REDCap entry details by clicking on the Sample Inventory Record link Navigation to the Hearts amp Minds clinic records If you have permissions to view this module the default view will show that there is no
17. User Account Request form to CVDMC requests sickkids ca or you can fax the completed form to 1 416 813 8261 ATTENTION CVDMC If you are submitting by fax contact the CVDMC within 48 hours of submission at 1 416 813 7654 x 228304 You may download this form at www utoronto ca Signature of CVDMC Managing or Executive Director E Date User Account Request Form version 2 1 Apri 2011 Section 1 Figure 1 1 1 CVDMC user account request form Official release 2013 12 20 Page 7 of 39 Section 1 2 Requesting database module access Form required UTorCVDb database access request Form format fillable pdf Form fields 3 1 REDCap user email Please type in the email associated with your REDCap account This is required for CVDMC to provide you access to the database 2 Name of the databases check all that apply Please select the databases you need access to UTorCVDb main e Biobank e 22q11DS Name signature of the chief PI Please type in the name of the chief PI This is required for the CVDMC to verify the user has proper authorization from the chief to access the database Approximate time to complete the application for the user 2 minutes Official release 2013 12 20 Page 8 of 39 Section 1 3 Requesting database changes REDCap online Form required UTorCVDb database field change request Form format REDCap online Fields Please follow the link below to submit an online req
18. abase A scheduled or unscheduled occurrence for which data is captured using a predefined CRF DCI Status of the form completeness and denoted with a color red incomplete yellow unverified green complete The ultimate person who is in charge of the database project The person who has access to a database project Access is provided on a project by project basis as determined by the chief of the project Each project may have many users each user may have many projects Users will only see projects listed in their My Projects page for which they have access and within a project they will only see the CRFs to which they have access Official release 2013 12 20 Page 29 of 39 Mild FEV1 60 to 75 of predicted and or on chronic inhaled or oral bronchodilator therapy Chronic lung disease Moderate FEV1 50 to 59 of predicted and or on chronic steroid therapy aimed at lung disease Severe FEV1 lt 50 predicted and or Room Air pO2 lt 60 or Room Air pCO2 gt 50 Yes reset J Yes current or previous diagnosis of dyslipidemia Hyperlipidemia any one of the following 1 Total chol gt 5 18mmol L 2 LOL gt 3 37 mmol L 3 HDL lt 1 04mmol L in men amp lt 1 30mmol L in women Section 2 Figure 2 3 1 Field note Section 2 4 UTorCVDb CVDMC database structure on REDCap v5 6 4 UTorCV database Navigation Module Module database 1 datrabase 2 Module database 3
19. ailed data is restricted by institution For queries regarding cross institutional data access please contact the CVDMC at cvdmc requests sickkids ca or CVDMC help desk at 416 813 7654 x 228304 Navigation panel for Heart amp Mind clinic Date of last H amp M clinic assessment None Add a new clinic assessment for this patient Date of last update of patient level data 2013 10 02 Update Patient Data Section 2 Figure 2 2 15 Hearts and Minds with patient data Here you see that we now have a date for when the record was updated as we just inserted a new record You can update the patient record by clicking on Update Patient Data to make any changes To add a new assessment record click on the ADD A NEW CLINIC ASSESSMENT FOR THIS PATIENT LINK This will take you to REDCap where you will be able to enter the needed data for the assessment as shown below Official release 2013 12 20 Page 26 of 39 22311 Assessment Followup Functional Assessment 2 Modfy this instrument 56 VIDEO Basi 16 min ws Download PDF of select PDF download option Editing existing Record ID 1 3 Record ID To rename this record modify the value immediately below Record ID Patient ID 54c867e6e4226bb840782bcf2868k must provide value Date of assessment 2013 10 15 33 Today SOCIAL FUNCTIONING Married or common law Marital status Separated divorced or annulled Never married reset Never Previous only Romantic re
20. answer the security question below In what city or town was your first job Submit Query REDCap Password Recovery You may use this page to reset your REDCap password You must first provide your REDCap username and once itis verified as an authentic REDCap account you will then need to answer a security question that you have previously set for yourself If you answer the security question correctly your password will be reset and an email will be sent to you containing a temporary password to access your account amp SUCCESS You correctly answered the security question An email containing your new temporary password has just been sent to the email address associated with the REDCap username tanveer collins Please do not refresh this page as t will re send the email with a new password Go back to Login page Section 1 Figure 1 4 1 REDCap password recovery using security question Rh3K 9rDE a2 DMC P HQ3a A Official release 2013 12 20 Page 10 of 39 This message was automatically generated by REDCap Your password has been reset for the following application REDCap https redcapextemal research sickkids ca Use the following information to log in Username tanveer collins Password f0ea79 You will be prompted to change your password the next time you log in If you have any questions please contact ResearchHelpDesk ResearchHelpDesk sickkids ca
21. art Minds clinic record Yes Hearts and Minds navigation panel Section 2 Figure 2 2 4 NavPanel with surgical record As you can see the surgery that we entered is now showing and quickly tells us that this patient has had a wide variety of surgeries performed at Toronto General Hospital on the 27th of September 2013 If this user was a staff member of Toronto General this data would show as a link where upon being clicked would show the REDCap record for this surgery As the amount of enteries rise the main navigational panel will limit the surgeries displayed to only the most recent three So how do we view all of the surgeries for this patient if they have more than three GV DMC Ne Official release 2013 12 20 Page 20 of 39 If you look at Figure 2 2 4 you ll see a new link has appeared named Show all surgeries for this patient Click on this link and the following screen will appear which will look like the one shown in Figure 2 2 5 Ays NAVIGATION UTorCVDb MODULES Patient ID 54c867e6e4226bb840782bcf2868b05cd1e3cb5a3a 7777080238d52e1634091c Note to user the information included in this navigation panel gives a summary of the data holding for this given patients across the CVDMC environment Access to detailed data is restricted by institution For queries regarding cross institutional data access please contact the CVDMC at cvdmc requests sickkids ca or CVDMC help desk at 416 813 7654 x 228304
22. atient ID from the top of the page as it will be needed UTorCVDb Follow up status Utorcvdb Patient Followup Modify this instrument VIDEO Basic data entry 16 min ps Download PDF of select PDF download option Adding new Record ID 1 Record ID 1 Patient ID must provide value Please enter the ONCOA generated ID Alive Current status Dead reset Date of last contact 32 Today Date of last clinical follow up Today Section 2 Figure 2 2 7 Short followup form Once you have completed entering data with this form hit save and proceed back to the navigation panel and press F5 to refresh the page You should now see the following Link to Followup Current status Alive Date of last contact 2013 10 04 Update Note to users date of last contact should be verified and updated if necessary every time the record is accessed Date of last clinical follow up 2013 10 04 Update new clinical followup Section 2 Figure 2 2 8 Followup module with data From here you can click Update new clinical follow up to enter a new clinical visit with the patient The page you should see when you click on that link is the following Official release 2013 12 20 Page 22 of 39 UTorCVDb Surgical Follow up Patient Status Adding new Record ID 1 Record ID Patient ID must provide value Status of patient at the time of last follow up Date of the most recent clinical follow up Today
23. clinical assessment for this patient to show every date that a clinical assessment has been performed Official release 2013 12 20 Page 28 of 39 Section 2 3 What is REDCap v5 6 4 REDCap is a secure web based application for managing clinical data and UTorTCV CVDMC databases are built on the REDCap platform The following sections will review the structure and basic principles of data entry using REDCap interface Alternatively you can get an overview on data entry from the REDCap HELP panel Term Project database Case report form CRF or Data collection instrument DCI Section Field variable Field note Record Study ID Event Visit Form status Chief Principal investigator PI User Gy D M C Description Each REDCap project is a single database into which data will be stored A form created for the purposes of capturing data Each database may contain multiple DCI CRFs Each DCI or CRF is divided into multiple sections to organize similar fields together Each section is composed of several fields Area that captures one single information or data Some fields have a field note shown in small font below the data field These notes provide field specific information to assist the person entering data and preserve data quality See figure below A complete set of information for a person or object Each record is composed of one or more fields A unique key that can identify each record in the dat
24. d and security question Please log out and log back in using your new password Approximate time to complete the application for the user 5 minutes Please find the screenshot of the form below CV DMC CARDIOVASCULAR DATA MANAGEMENT CENTRE amp User Account Request Form Form version date April 17 2013 Read Write X Export IR STS Cardiac Surgery Read T Write Expot T Cardiology ECHO Read T Write M Expot M Hearts amp Minds Clinic Toronto General Hospital only Read T Write Expot Blobank Read T Write m Expot T Do you have an existing REDCap account Yes No T if yes please indicate your username By signing below agree that in accordance with the Personal Health Information Protection Act of Ontario am responsible for adhering to all conditions and restrictions imposed by the CVDMC and local policies governing the use security disclosure return and disposal of any personal healthy information am also responsible for reporting immediately any privacy breaches to the CVDMC and appropriate local REB Chair will ensure that the personal health information is used only as necessary to fulfill the specific objectives imposed by the CVDMC Name print Signature aS Signature of Chief of Clinical Division is required Please fill out all necessary fields and provide the required signatures You can scan upload and e mail the completed
25. e Section 3 Figure 3 6 1 Saving CRFs in REDCap skl0009 Today Today v Today Incomplete v Save and go to Next Form Cancel Official release 2013 12 20 Page 37 of 39 Save Record Saves the data and returns to the record study ID selection screen for the current form Save and Continue Saves the record and remains on the form for the same Study ID Save and go to Next Form Saves and navigates to the next form on the list for the study ID Cancel Leaves the current screen and DOES NOT SAVE the changes you made lf you want to save the changes made you must press enter or click one of the three save options mentioned above before navigating off the form screen Locking and e signatures If you have locking and or e signature rights you may choose to lock the form and or e sign the form Delete record Deletes the complete set of data that exist across all CRFs for one particular study ID This will be followed by a warning message see figure below asking if it is okay to permanently delete this record and its data DELETE RECORD 1 Are you sure you wish to PERMANENTLY delete this record and its data Section 3 Figure 3 6 2 Warning message when deleting a record in REDCap Official release 2013 12 20 Page 38 of 39 Section 3 7 Correction of data after locking Correction of data after a record has been locked is possible only by CVDMC staff
26. e Log In Forgot your password Section 2 Figure 2 2 1 REDCap login screen Here you can see we have a sample user named creed ready to log in Verify your username and password make sure that your caps lock isn t on and once entered hit log in If unsuccessful it will ask you to try logging in again Otherwise here s screen you should now being seeing as shown by Figure 2 2 2 NAVIGATION TO UTorCVDb MODULES Patient ID ff792daa887abaa327ca9d5e9c5b367 36ef581e36b48c96c1b109cc6d247ed7e Note to user the information included in this navigation panel gives a summary of the data holding for this given patients across the CVDMC ey V D M C environment Access to detailed data is restricted by institution For queries regarding cross institutional data access please contact the CVDMC at cvdmc requests sickkids ca or CVDMC help desk at 416 813 7654 x 228304 Logout Link to UofTCVDb SURGICAL dB Add new surgery for this patient Link to Followup Date of last contact None Update Note to users date of last contact should be verified and updated if necessary every time the record is accessed Date of last clinical follow up None Add new clinical followup Link to Biobank Sample available in biobank No i amp i i li 1 Hearts and Minds navigation panel TTT tr Section 2 Figure 2 2 2 Empty Patient Navigational Panel There are a few things to view and verify here First make sure that you had a po
27. eset password to find the following pop up screen see below Password must be between 10 15 characters long and contain at least one lower case letter one upper case letter and one number Do you wish to reset your password for logging in to REDCap If so you will be asked to set your new password now Password Changed Your password has now been changed You may now click the button below to navigate back to REDCap Continue gt gt Section 1 Figure 1 5 1 REDCap password reset Official release 2013 12 20 Page 12 of 39 Section 1 6 User account deletion and access control UTorCVDb user access will be reviewed by the CVDMC every year Furthermore user account can be changes or deleted anytime when there is a request from Chief of division or local CVDMC administrators Upon receiving the email for a request to change the level of access or delete a user account CVDMC managing director will complete the process in the two steps mentioned below 1 UTorCV databases access CVDMC managing director will prohibit access to the databases within 1 business day of receiving the notification to delete the user account Access level change requests will be processed within the same time frame The user without the access to the UTorCV databases will come across the following message ACCESS DENIED You have no access rights to this page Please see ResearchHelpDesk for additional details Section 1 Figure 1 6 1 Onl
28. from the navigation panel screen as it ll be needed Patient Features Modfy this instrument VIDEO Basic data entry 16 min pi Download PDF of select PDF download option M Editing existing Record ID 1 Patient ID 54c867e6e4226bb840782bcf2868b05cd1e3cb5a3a7777080238d52e1634091c 1 To rename this record modify the value immediately below Patient ID must provide value Record ID 54c867e6e4226bb840782bcf2868k Record last updated on paa 2013 10 02 1 Today Smusterovde AE OSS DEMOGRAPHICS Age years 56 Female Gender 9 Male reset BMI 22 FAMILY HISTORY Yes Family history of CHD No reset if YES please specify in the pop up field below SCREENING AND DIAGNOSIS OF PROBAND FISH Molecular screening method SNP markers MLPA Section 2 Figure 2 2 14 Hearts and Minds REDcap Patient database Make sure to have the patientID and Record Last updated on fields filled out Both are required both will cause issues if they are not entered correctly Once the new record is saved refresh the navigation panel screen hit 5 on your keyboard and you should see the following Official release 2013 12 20 Page 25 of 39 NAVIGATION UTorCVDb MODULES Patient ID 54c867e6e4226bb840782bcf2868b05cd1e3cb5a3a7777080238d52e1634091c Note to user the information included in this navigation panel gives a summary of the data holding for this given patients across the CVDMC environment Access to det
29. ine message when user has no access to REDCap databases 2 SickKids REDCap account access User s SickKids REDCap account will be deleted provided the user does not require access to any other databases hosted at the SickKids server In this case the email with the request will be forwarded to the SickKids REDCap administrators Following message will appear when the user with no SickKids REDCap account will try to access the database link ERROR You entered an invalid user name or password Section 1 Figure 1 6 2 Online message when user has no or invalid REDCap account Gy D M C be Ne Official release 2013 12 20 Page 13 of 39 Section 2 Database structure and walkthrough Section 2 1 Patient identifier encryption using ONCOA Patient identifier encryption software ONCOA will allow users to be able to work on specific patient data cross sites without the issues of privacy or PHI arising as once the unique ID for patients are created no PHI data is ever transmitted across networks removing a possible impediment with working on specific patient records When you enter whatever URL you ve decided on on first load you ll be presented with a screen asking you for a username and password If you don t have an ONCOA user name please ask your manager Verify that you have it before continuing as it is not the same as your REDCap login See figure below Application Login Username ltestuser Password _Logi
30. lationship Current only Both current and previous reset House or apartment Home environment Boarding house group home Hospital treatment facility Section 2 Figure 2 2 16 Hearts and Minds REDCap assessment screen As with the patient form make sure that both patient ID has been copied and pasted from the navigation panel screen and that date of assessment has been entered Once you have saved the new record refresh the navigation panel screen You should now see the following Official release 2013 12 20 Page 27 of 39 NAVIGATION TO UTorCVDb MODULES Patient ID 54c867e6e4226bb840782bcf2868b05cd1e3cb5a3a7777080238d52e1634091 c Note to user the information included in this navigation panel gives a summary of the data holding for this given patients across the CVDMC environment Access to detailed data is restricted by institution For queries regarding cross institutional data access please contact the CVDMC at cvdmc requests sickkids ca or CVDMC help desk at 416 813 7654 x 228304 Navigation panel for Heart amp Mind clinic Date of last H amp M clinic assessment 2013 10 15 Show H amp M clinical assessment for this patient Add a new clinic assessment for this patient Date of last update of patient level data 2013 10 02 Update Patient Data Section 2 Figure 2 2 17 Hearts and Minds record for complete patient data and at least one clinical record From here you can now click on Show all H amp M
31. ld by keyboard strokes or clicking the mouse Move to the next field by clicking in it or pressing the Tab key To remove previously entered value please delete the value from textboxes checkboxes or click on the reset located beside the value to remove values from radio buttons or slider scales Please refer to section 3 5 for different types of data entry fields Navigate between fields using Tab or mouse clicks If you press Enter you will save the form and exit the current screen If you navigate off the form without pressing Enter or clicking on one of the Save buttons on screen your work will be lost If a field has validation associated it with you may see a warning or error message indicating that the value you entered does not match requirements set up for the field For example text fields may require the value entered fall between minimum and maximum values REDCap will not prevent you from continuing but it will alert you to a value that is outside the pre defined acceptable range See figure below Some fields are required to be filled out before you proceed to the next form When saving the CRF and proceeding to the next validation window will also prompt you to enter data if you miss to enter data into the required fields Alert The value you provided is outside the suggested range 10 40 This value is admissible but you may wish to verify Section 3 Figure 3 4 1 Data validation pop
32. mplanted or removed Yes No reset Yes Procedures performed on the aorta pulmonary arteries or Other cardiac procedure veins and or the intrathoracic inferior superior vena cava other than CABG and or Valve procedures This may also include but is not limited to left ventricular aneurysm LVA acquired ventricular septal defect VSD surgical ventricular restoration SVR transmyocardial revascularization TMR cardiac trauma pericardial window cardiac tumor or heart transplant Yes gt Complete form OR Other Cardiac Procedures Yes No reset Other non cardiac procedure Yes if patient underwent surgical removal of plaque or carotid stenting or any procedures involving other vessels thorax pleura in conjunction with the primary surgical procedure Yes gt Complete form OR Other non cardiac Procedures Section 2 Figure 2 2 3 Adding a new surgical record in REDCap Official release 2013 12 20 Page 19 of 39 First make sure that you enter the patient ID in the patient ID field from the navigation panel page You ll find the ID at the top of the page it s the super long string of numbers and letters If you know how to copy and paste data in a browser this will make it much easier to enter into the patient ID field Other than Patient ID there are three fields that should be entered to have the surgical record in the navigation panel show correctly Hospital The hospital that the surgery took place in Date of s
33. n Section 2 Figure 2 1 2 ONCOA login page Here you would enter the ONCOA login that was provided to you verifying that you have the username and password typed in correctly and the caps lock not turned on Once finished click Login to submit your username and password into the ONCOA software for validation Upon successful log in you ll see the following screen as shown in Figure 2 1 2 Ar V GV D M C Official release 2013 12 20 Page 14 of 39 Search for patient information Search Search by Select an option to search by z Submit Section 2 Figure 2 1 2 ONCOA main screen One the main screen see the figure 2 2 2 above you will be able to search for data by the patients OHIP number their number or their last name You will need to enter data in the Search by field along with what type of data you are searching for in the dropdown below Not entering anything in the Search field or not selecting an option in the Search By field will cause your form to fail on submission highlighting what items were missing for easy identification Verify that all fields have the correct values and then try again If no error occurs submitting the aforementioned form one of three actions will occur depending on the result of the search GV DM C A No match could be found When searching for the particular patient OHIP number MRN number or last name there was not a
34. nihiot Most recent activity 04 23 2013 7 04pm s never C3 Data Export Tool Cedric Manthiot Space usage for docs 129 Data Import Tool never Project status P Development Data Comparison Tool cyvdmc smh a e mae cvdme smh cvdme sr ais 3 Upcoming Calendar Events next 7 days i ae 7 amp User Rights cvdme sun cvdme su ago pine ate Description amp Record Locking Customization spooning events E signature and Locking Mgmt evdme tgh cvdme tgh bA Graphical Data View amp Stats tanveer collins 5 ever amp Data Quality fenvesr Couns E Report Builder Help amp Information Section 3 Figure 3 1 3 REDCap interface main window Rh3K 9r DE a2 Official release 2013 12 20 Page 32 of 39 Section 3 2 Adding selecting a record Click on add edit records from the left panel UofTCVDb Main surgical dB REDCap Preop History VIDEO Basic data entry 16 min tanveer collins y Logout Download POF of select PDF download option hy Projects You may view an existing record response by selecting it from one of the drop down lists below The records are separated into amp Project Home each drop down list according to their status for this particular data collection instrument To create a new record response click Project Setup the button below status Development Data Collecti Edt instruments Total records 1 E Record Status Dashboard
35. ort ONCOA data export RC record unlocking 0 2 2 2 0 0 2 2 0 Local CVDMC administrator Data clerks administrative assistants BEBE 0 10 20 N N 0 10 00 0 Rationale for access Full administrative rights to oversee all the processes the CVDMC staffs are involved in Once a record is locked only CVDMC directors can unlock it for further data entry edits When required decryption of IDs will be done Database modifications and user account setup would be done through the backend panels Access to data entry and export is required to generate reports for QI amp for analysis purposes Data entry and record deletion rights to validate existing data Can lock records following data validation This level of access will allow CVDMC admin assistants to keep track of all database changes and also to ensure data quality Site level administrative rights to oversee the CVDMC databases Data export and report generation functionality for QI amp site level data analysis View create or edit records and report generation to facilitate the physician level data entry Prior approval required for data export Report generation for the site level QI work Can delete site specific patient data Prior approval required for data export Access limited to data entry view create amp edit records only Database setup and modifications user rights 3 global 2 site level 1 physician level C CVDMC approval
36. p Project Home Project Setup Other Functionality 2 Project Revision History Quick Tasks Export data Create a report Check data quality Export your data from REDCap to open or view in Excel or various stats packages Build custom reports for quick views of your data and export reports to Excel CSV Build or execute data quality rules to find discrepancies and errors in your project data Create new records edit view existing ones User Rights Grant new users access to this project or modify user privileges for current users prea ne Online Designer and Create new fields questions on your data collection instruments or modify existing ones using the Data Dictionary Upload Online Designer or by uploading a Data Dictionary Quick link Download the current Data Dictionary heat Sala Access Groupe Create groups of users to limit user access to certain records responses in which only users within coan PS a given Data Access Group can access records created by users within that group Preop History Preop Cardiac Status OR Common OR CAB Project Dashboard OR Valve Surgery The tables below provide general dashboard information such as a list of all users with access to this project general project OR Mech Cardiac Assist Devices statistics and upcoming calendar events if any OR Other Cardiac Procedures Postop amp Current Users C Project Statistics User Expires Records in project 2 3 Calendar cedric ma
37. p up window appear showing you the patient name and If no popup appeared you may have a popup blocker and DM C Official release 2013 12 20 Page 18 of 39 may need to have IT resolve that issue Once this is completed we see the ID for the patient along with four sections These relate to the following types of data Surgical dB This will display all surgical related information Followup This display the last contact with the patient and their last clinical followup date Biobank This will show what specimen if any is available for this patient Hearts amp Minds This applies for Heart amp Minds clinic related activities and assessments Let s start with entering a surgical record for our patient Click on the Add new surgery for this patient link This will open a new tab which will load the corresponding REDCap database screen for adding a new surgical record as showing in Figure 2 2 3 Record ID To rename this record modify the value immediately belon Record ID TEST Local database coordinator has ID unlocking Patient ID TEST must provide value Please enter the ONCOA generated ID Date of operation fa Today Yes No oronary artery bypass reset Yes gt Complete form OR CABG Yes No Valve surgery reset Yes gt Provide answers to the 4 pop fields below and Complete form OR Valve Surgery No Yes gt Complete form OR Mech Cardiac Assist Devices VAD i
38. ssssececcesecceceeseceeaeseceseeeeceeseeeecessuaeeeeesuneeeetenes 39 Section 3 8 Data security ANd privacy violation cccccesecccssecccesceceeseeceeececeseceeeneeseeeeesenceseeeeensaeeees 39 GN DM C he NY Official release 2013 12 20 Page 2 of 39 Background Improving care for patients with cardiovascular disease at multiple hospitals within the University of Toronto is dependent upon the extraction of knowledge from clinical activities We can improve the efficiency and productivity of the clinical and research missions by pooling data from multiple sites within an easily accessible management structure which facilitates quality improvement activity and clinical research for contributing members The purpose of this document is to delineate the standard manual of operations of cardiovascular data management centre CVDMC which is created to server the contributing members for the cardiovascular care community within the University of Toronto The global vision of the CVDMC is to create a collaborative community of clinicians and researchers across the University united by a common interest in cardiovascular disease and a dedication to extracting new knowledge from our clinical and scientific activities This collaborative community will be defined as the membership The academic centerpiece of this community will be the CVDMC The critical ingredient is a Common Database of the cardiovascular data which can be divided into t
39. structure and walkthrough ccccssscccssseccceseceeesccceenceceeececeeeeeeeeeeeecesseeecessneceneuess 14 Section 2 1 Patient identifier encryption 14 SECTION 2 17 56 2 5 1 5 551 eck varesaevts taser ete laantesiaeweeaie 29 Section 2 4 UTorCVDb CVDMC database structure 5 6 4 30 SECTIONS Data 31 Section 3 1 REDCap web interface main 31 Section 3 2 Adding selecting a FOC ON E i TENEN EERE E i 33 Section 3 3 Navigating across CRFs of a record ssessssssssrressrrrserrrsrersrrrsrteurtrrnsrresrtesetererersrerserrrsererens 34 Section 3 4 Data entry amp validation esessssenssenssrressrrsserssressrrrsrrrreserrsrrrssrrssrersrerssreessreesreesseresereseeres 35 section eld iS T S RO a NO 36 OCON o O A 3 Section 3 7 Correction data after locking ccccccsscccc
40. th the Privacy Office to make appropriate changes as necessary The completed assessment report will be forwarded to the institution The Hospital for Sick Children has several policies dealing with security violations and prevention Please see the attached policies e Information Security Policy e Theft Loss Prevention and Reporting policy CVDMC is bound by all policies and procedures governed at SickKids for privacy and security of data CVDMC will use the REDCap built in user rights panel data and user tracking systems to ensure data entry is following the appropriate protocol Please refer to the CVDMC Manual of Operations for description of the data security systems Official release 2013 12 20 Page 39 of 39
41. tudy ID is entered in the new existing record field new data form will not appear the form with existing data for that ID will appear instead This is because REDCap checks that the study ID you entered is unique before creating a new record If the study ID does not exist only then a new record is created and the data form with no data appears Official release 2013 12 20 Page 33 of 39 Section 3 3 Navigating across CRFs of a record When the first CRF appears on the right panel see figure below the left panel will list all the CRFs in the Data Collection section You can now navigate across the same study ID by selecting the CRF from the list in the left panel REDCap Logged in as site_admin H iy Projects amp Project Home E Project Setup Project status Production Data Collection Record Status Dashboard Add Edit Records Study ID 12 Select other record Data Collection Instruments Demographics Baseline Data A 111 i D 1 Month 2 Data Month 3 Data Completion Data Applications 3 Calendar C Data Export Tool 4 Data Import Tool CA Data Comparison Tool Logging File Repository IA Graphical Data View amp Stats ig Data Quality i Report Builder Reports 1 Long Term Outcomes in Epilepsy amp Help amp Information Help amp FAQ o Video Tutorials Suggest a New Feature If you are experiencing problems please contact your REDCap administrator
42. uest Approximate time to complete the application for the user 4 minutes DMC Official release 2013 12 20 Page 9 of 39 Section 1 4 Requesting password recovery In case of a forgotten password please follow the steps below to reset the password for your REDCap account Beside the log in tab on the REDCap home page click on forgot your password to display the password recovery windows as below Please check your email after a minute or two to get the password A paper application is not required since the password reset is processed online REDCap Password Recovery You may use this page to reset your REDCap password You must first provide your REDCap username and once itis verified as an authentic REDCap account you will then need to answer a security question that you have previously set for yourself If you answer the security question correctly your password will be reset and an email will be sent to you containing a temporary password to access your account Username REDCap Password Recovery You may use this page to reset your REDCap password You must first provide your REDCap username and once itis verified as an authentic REDCap account you will then need to answer a security question that you have previously set for yourself If you answer the security question correctly your password will be reset and an email will be sent to you containing a temporary password to access your account Please
43. urgery Surgery type This will be found below Date of operation in the Surgical Database section Fill out as much as you can and then hit save record to save your changes You can then close this tab in your browser When you are back at the navigational panel refresh the page hitting f5 here will perform this function and it will update all records for this patient So for our example you should see the following as per figure 2 2 4 NAVIGATION TO UTorCVDb MODULES Patient ID 54c867e6e4226bb840782bcf2868b05cd1e3cb5a3a7777080238d52e1634091c Note to user the information included in this navigation panel gives a summary of the data holding for this given patients across the CVDMC V D M environment Access to detailed data is restricted by institution For queries regarding cross institutional data access please contact the CVDMC at cvdme requests sickkids ca or CVDMC help desk at 416 813 7654 x 228304 f Sge Logout Link to Vof TCVDb SURGICAL dB ID 1 2013 09 27 CABG AV Replacement MV Repair Other TV Other PV Other Procedure TGH Si ies for thi tient Add new surgery for this patient Link to Followup Date of last contact 2013 09 02 Update Note to users date of last contact should be verified and updated if necessary every time the record is accessed Date of last clinical follow up 2013 09 09 linical fol Link to Biobank Sample available in biobank Yes Sample Inventory Record He
44. wo general streams the establishment of a registry for quality improvement QI and the establishment of a mechanism to facilitate clinical research activity The merged database will therefore serve two separate but complimentary purposes The creation and management of the Common Database will be orchestrated by the CVDMC Project general description The primary collection of personal health information PHI by the CVDMC is for clinical care purposes Information is collected directly from the patient medical records The data is subsequently de identified at the collection site and disclosed to the CVDMC in a de identified format for research and or quality assurance purposes Objectives 1 Registry data Provide easily accessible QI reporting for clinical groups contributing data to the CVDMC a Reports will be available to each hospital chief each faculty participant and the division chair using appropriate privacy guideline established by the CVDMC oversight board b Use of registry data will allow freely available automated risk adjusted and risk stratified comparisons with aggregated data from the Division 2 Clinical research Facilitate University wide clinical research a Respond to database queries from any member contributing to the CVDMC database b Manage expansion of the database as required with new layers of data fields to facilitate clinical research projects c Provide statistical support assistance with study design
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