MADCaP REDCap Database Study User guide

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1 MADCaP REDCap Database Study User guide

2 Table of Contents Here is why REDCap will be used by MADCaP:... 3 Here are the steps you need to take to access the REDCap database:... 3 Logging in... 3 Links in upper right corner... 3 REDCap menu:... 4 MADCaP Project:... 4 Project Home... 5 Codebook... 5 Export Data... 6 Create a Report... 6 Left Hand Menu... 6 Data Collection... 6 Data entry... 8 Applications Calendar Data Exports, Reports, and Stats Project Bookmarks Reports Help & Information Appendices Data Dictionary Codebook Data Collection Instruments

3 Here is why REDCap will be used by MADCaP: The purpose of the REDCap MADCaP database is for each participating center to be able to track case and control patient encounters and information related to their contact details, eligibility for enrollment as a case/control and enrollment specifics. The information maintained in this database contains identifiers and therefore each center s access is separate so that only study staff working at each Institution and listed on the local IRB approved protocol are able to login and track their own patients. Study staff will also be able to undertake querying and utilize reporting tools to assess enrollment success. REDCap permits the following: Export of data to common data analysis packages including Microsoft Excel, PDF, SAS, Stata, R, or SPSS for analysis. Creation of custom queries for generating reports to view or download. Scheduling utilizing the built in project calendar and scheduling module for organizing events and appointments. Sending of files securely to multiple recipients that are too large for attachments or contain sensitive data. Saving data collection instruments as a PDF to print. Here are the steps you need to take to access the REDCap database: Logging in 1. Navigate to the REDCap page (this can be a favorite on your browser): 2. Log in with your username and password Links in upper right corner My Profile will permit you to: o Change your profile preferences ( , password, date/time format). Log out: This logs you out as a user. 3

4 REDCap menu: Home is the default tab when you log in and contains a link to a brief summary video. My Projects o MADCaP records, fields, instruments (forms) are accessed through the MADCaP link. Request New Project (only accessible to DFCI & Partners Institutions). Training Resources: This provides several different videos. The first 3 contain information on fundamental concepts and features that would be of use if you have not used REDCap previously. The Basic Features & Modules section shows videos to guide the user through some of REDCap s special features. Help & FAQ: Provides information generally, on project setup/design, data collection instrument design, data entry/collection, applications, making production changes and optional modules and services. Send it: This is a secure data transfer application that allows you to upload a file (up to 12 MB in size) and allow multiple recipients to download the file in a secure manner. MADCaP Project: 1. Select My Projects from the REDCap menu below: 4

5 2. Click on MADCaP The top menu has a link to Project Home and Project Setup. We will not be using Project Setup. It shows different stages of database development prior to going into production and will not be used further at this time. Project Home This menu has clickable links to Quick Tasks (Codebook, Export data, Create a report) and Project Dashboard (Table of users with access to this project, general statistics and upcoming calendar events). Codebook This provides a human readable, read only version of the project s Data Dictionary and a resource to quickly view field attributes. The Data Dictionary Codebook from REDCap for this study is displayed in the Appendix (at the end of this guide). 5

6 Export Data This enables data to be exported from REDCap and viewed in external software packages like Excel. We will review this section later in the Applications Menu (see page 15). Create a Report This enables users to create queries of their data for an immediate look at participants. Reports may be shared across users. We will review this section later (see page 16). Left Hand Menu The first section of this menu has links to My Projects, Project Home and Project Setup with features as described above. Data Collection Next, is the Data Collection menu which is devoted to data entry and contains links to each data collection instrument/survey for the study that will be maintained in REDCap and where management of participant data takes place including adding and editing of records. You can only create or edit records through the Add/Edit Records section of the Data Collection section. 6

7 REDCap has a helpful tutorial on Basic data entry: REDCap basic data entry The Data collection Instruments for the study are as follows: Cover Sheet Information Eligibility Form Enrollment Information Other Patient Encounters These Forms are located in the Appendices section at the end of this user guide. 7

8 Data entry Adding a new record A new record (new individual) is created by: 1. Clicking on Add/Edit Records 2. Clicking on the first Data collection Instrument, Cover sheet information 3. Clicking on Add/Edit Records 8

9 1) Data can then be entered into each field from the Cover Sheet form starting with the Interview Date field. The Record ID is an ID that is automatically assigned by REDCap and is internal to REDCap. It is not being used to track participants in this study. The Participant ID is MADCaP s study ID. When entering the Participant ID make sure that it is entered in this format: year case/control center ID. If the research subject DIDN T enroll in the study yet this field can be left blank and entered at a later date (once enrolled). This form can be opened again and edited. A new form is NOT needed. *Note: there are small changes to this form and other forms, and creation of new form(s) in the REDCaP MADCaP database in order to aid the MADCaP centers in tracking patient encounters. 9

10 2) After completing all selections for the form the final field Complete has the following options to be selected: Incomplete (data still pending entry) Unverified (pending second person checking for accuracy of data) Complete (all date entered) Edits can be made later to any form, even if it is coded Complete. 3) The final step is to select either Save record, Save and continue, Save and go to Next Form or Cancel. This selection can either be made at the bottom of the online form or in the top right corner. Selecting Complete and Save Record takes you out of the form and back to the Cover Sheet Information main page. The left menu shows the Participant Id (Record ID) and the Cover Sheet is green to indicate it is complete. It would be red if Incomplete had been selected previously when entering the form. The main pane shows the total number of records in the group. 10

11 Save and Continue saves the form and keeps you in the form. Save and go to Next Form saves the form and brings up the next form in our study, the Eligibility Form. Scroll down on the Cover Sheet Information form and Select Save and go to Next Form to continue entering data for this study participant. 11

12 The next form is the Eligibility Form. Depending on whether Case or Control is selected will change the flow of questions that will be completed. 12

13 Case selected: Case specific questions Control selected: Control specific questions 13

14 The next form is Enrollment Information. 14

15 The last form is Other Patient Encounters. This Form is to help track dates and what was collected on three different encounters with a potential study participant. 15

16 Applications The Applications section contains tools available in REDCap but not commonly used in Data entry. Calendar Upcoming appointments, enrollment meetings and other encounters for cases and control can be scheduled and tracked using the calendar. A new appointment can simply be created by clicking +New to the left of the day, at a minimum a name or description must be entered into the notes field for each new event. tudy team progress can also be tracked using the calendar. Upcoming events also appear on the Project Home tab. A calendar event can be linked to a study participant record as required and also to select and complete existing required data entry forms. REDCap has a helpful tutorial describing how to use the calendar: REDCap calendar 16

17 Data Exports, Reports, and Stats This section allows a new report to be created (accessible to all users or as custom access) and saved for future querying with field/variable selection as required. 17

18 An example of customizing and then displaying a customized report are displayed below where the fields: Record Id, Participant ID, Date of birth, MRN, Case/Control, and Clinic/Department where identified, have been selected to appear and filtered to only show Cases. 18

19 Data can be exported to multiple different formats (Excel/CSV, SAS, SPSS, R, Stata) by selecting My Reports & Exports, Selecting Export Data, Export format and Export data. 19

20 The entire data set can also be selected for export as a pdf file: REDCap has a helpful tutorial describing how to use Data exports, Reports and Stats: REDCap Data exports, Reports and Stats 20

21 Project Bookmarks The bookmark listed here links to the Datstat discovery database. Reports This show all reports that have been created and shared with this group. Help & Information This section provides more information on additional tools and resources available in REDCap as well as providing tools and helpful video tutorials and information to familiarize yourself with REDCap. QUESTIONS? Please contact Caroline Andrews at 21

22 Appendices The Data Dictionary Codebook and Data Collection Instruments for the MADCaP REDCap database are located in this section: Data Dictionary Codebook # Variable / Field Name Field Label Field Note Field Attributes (Field Type, Validation, Choices, Calculations, etc.) Instrument:Cover Sheet Information 1 record_id Record ID text 2 int_date Interview Date (day-monthyear) 3 int_initials Interviewer Initials text 4 participantid Participant ID text text (date_dmy) Custom alignment: RH Custom alignment: RH (Only if enrolled) Custom alignment: RH year-case/control-center-id 5 medrec Medical Record # text, Identifier Custom alignment: RH 6 urologist Urologist name text 7 oncologist Oncologist name text 8 first_name First name text, Identifier Custom alignment: RH 9 middle_name Middle initial text Custom alignment: RH 10 last_name Last name text, Identifier Custom alignment: RH 11 addr1 Participant Address 1 text, Identifier Custom alignment: RH 12 addr2 Participant Address 2 text, Identifier Custom alignment: RH 13 city Participant City text Custom alignment: RH 14 postcode Postal code text Custom alignment: RH 15 country Country radio 22

23 1 Ghana 2 Nigeria 3 Senegal 4 South Africa 16 cell_code Cell Phone Country Code text, Identifier Custom alignment: RH 17 cell_phone Cell Phone Number text, Identifier Custom alignment: RH 18 phone2 Additional phone number text, Identifier Custom alignment: RH 19 dob Date of Birth (day-month-year) text (date_dmy), Identifier Custom alignment: RH 20 text ( ), Identifier 21 cover_sheet_information_co mplete Complete? Custom alignment: RH dropdown 0 Incomplete 1 Unverified 2 Complete Instrument:Eligibility Form 22 participantid_case Participant ID text (year-case/control-center-id) 23 elig_date Today's Date (day-monthyear) text (date_dmy) 24 age Age (in years) text (integer, Min: 30, Max: 89) 25 age_elig Age eligible radio 26 black_elig Black, African ancestry eligible radio 27 geographic_elig Male resident of geographic region 1 Yes 0 No 1 Yes 0 No radio 1 Yes 0 No 28 status2 Case or Control? radio, Required 1 Case 2 Control 23

24 29 pc_date Date Prostate Cancer text (date_dmy) Diagnosis Show the field ONLY if: (day-month-year) [status2] = '1' 30 pcdate_elig Prostate Cancer Date eligible radio Show the field ONLY if: 1 Yes [status2] = '1' 0 No 31 clinic_case Clinic/Department identified from radio Show the field ONLY if: 1 Urology [status2] = '1' 2 Oncology 3 Other 32 other_dept_case Other department, institution text Show the field ONLY if: [clinic_case] = '3' and [status2] = '1' 33 dept_control Please check Department where subject was radio Show the field ONLY if: approached. 1 Orthopaedic [status2] = '2' 2 Internal medicine 3 Family medicine 4 Blood Donation Services 5 General surgery 6 Gastrointestinal 7 Geriatrics 8 Dermatology 9 Cardiology 10 Opthalmology 24

25 34 institution Institution where Department Show the field ONLY if: is located text [status2] = '2' 35 dept_elig Department eligible radio Show the field ONLY if: 1 Yes [status2] = '2' 0 No 36 prevca_elig Previous cancer eligibility radio 1 Eligible NO PREVIOUS CANCER 0 Not eligible PREVIOUS CANCER 37 cancer1 Type Cancer 1 text Show the field ONLY if: [prevca_elig] = '0' 38 cancer1_date Date Cancer 1 text (date_dmy) Show the field ONLY if: [prevca_elig] = '0' (day-month-year) 39 cancer2 Type Cancer 2 text Show the field ONLY if: [prevca_elig] = '0' 40 cancer2_date Date Cancer 2 text (date_dmy) Show the field ONLY if: [prevca_elig] = '0' (day-month-year) 41 cogass_elig Pass Cognitive assessment radio 1 Yes 0 No 42 cog_score Cognitive Assessment Score text (Optional) 43 elig_initials Eligibility Form entered by text (initials): 44 mrn MRN text, Identifier 45 eligibility_form_complete Complete? dropdown 0 Incomplete 1 Unverified 2 Complete Instrument:Enrollment Information 25

26 46 site Recruitment Center radio 47 status Case/Control radio 48 language Language of Interview radio 49 oth_language Other language text Show the field ONLY if: [language] = '10' 50 inpatient Inpatient at the time of enrollment? 1 37 Military Hospital, Accra 2 Korle Bu Hospital, Accra 3 University College Hospital, Ibadan 4 Hôpital Général de Grand Yoff, Dakar 5 Stellenbosch University, Cape Town 6 WITS Health Consortium, Johannesburg 7 University of Abuja Teaching Hospital, Nigeria 1 Case 2 Control 1 English 2 French 3 Yoruba 4 Igbo 5 Hausa 6 Ibo 7 Wolof 8 Sereer 9 Pulaar 10 Other radio 1 Yes 0 No 26

27 51 interested During the first encounter, was subject interested in learning radio about the study? 1 Yes 0 No 52 interested_whynot If not interested, why not? text Show the field ONLY if: [interested] = '0' 53 eligible Was subject eligible according to Eligibility Form? radio 1 Yes 0 No 54 eligible_whynot If not eligible, why not? text Show the field ONLY if: [eligible] = '0' 55 consented Consented to study? radio 1 Yes 0 No 56 consented_whynot If not consented, why not? text Show the field ONLY if: [consented] = '0' 57 signed_consent If consented: checkbox Show the field ONLY if: 1 signed_consent 1 [consented] = '1' 2 signed_consent 2 58 type_consent Specify future use: radio Signed consent obtained Future specimen use Show the field ONLY if: 1 All future studies [consented] = '1' 2 Research directly related to this funded study 59 enroll_complete Did subject complete all enrollment steps? 3 Not consented to future studies radio 1 Yes 0 No 60 enroll_steps Enrollment Steps Completed checkbox 1 enroll_steps 1 Form 1. Case eligibility 27

28 61 enrollment_information_com plete Complete? Instrument:Other Patient Encounters 62 encounter2_date Second Encounter Date (day-month-year) text (date_dmy) 2 enroll_steps 2 Form 2. Control eligibility 3 enroll_steps 3 Form 3. Cognitive assessment 4 enroll_steps 4 Form 4. Consent 5 enroll_steps 5 Form 5. Cover Sheet 6 enroll_steps 6 Form 6. Questionnaire 7 enroll_steps 7 Form 7, Body Mass Index 8 enroll_steps 8 Form 8. Medical Record Abstraction, Case 9 enroll_steps 9 Form 9. Medical Record Abstraction, Control 10 enroll_steps enroll_steps 1 1 dropdown 0 Incomplete 1 Unverified 2 Complete Form 10. Biospecimen Collection Form 11. DNA metrics 63 encounter2_notes Second Encounter notes Tracking Information 64 consented2 Second Encounter radio Consented to Study? 1 Yes 65 consented2_whynot Second Encounter notes Show the field ONLY if: [consented2] = '0' Why did they NOT consent? 66 encounter3_date Third Encounter Date text (date_dmy) (day-month-year) 67 encounter3_notes Third Encounter notes Tracking Information 68 consented3 Third Encounter radio 0 No 28

29 Consented to Study? 1 Yes 0 No 69 consented3_whynot Third Encounter notes Show the field ONLY if: [consented3] = '0' 70 other_patient_enco unters_complete Why did they NOT consent? Complete? dropdown 0 Incomplete 1 Unverified 2 Complete 29

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