Getting Started. No approval is required for operational surveys. Cite: CTSA NIH Grant UL1- RR024982

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1 Getting Started PREREQUISITES FOR USE If cllecting data fr the purpse f human subject s research, review and apprval f the prject by the Institutinal Review Bard is required. If cllecting data fr clinical quality cntrl, apprval by the CQO is required at UT Suthwestern and the CMIO s at Parkland and Children s Medical Center. N apprval is required fr peratinal surveys. Cite: CTSA NIH Grant UL1- RR

2 Cntents Getting Started 1. INTRODUCTION GENERAL INFORMATION Access t REDCap Cmpliance Training Supprt HOW TO USE REDCAP Definitin and wrding Prject wrkflw Build and test a prject Prerequisites Build a prject Test a prject Mve a prject int prductin mde Enter, Review and analyze data Enter data Review data Analyze data De- identificatin methds fr data exprting Clse a prject

3 1. Intrductin Getting Started REDCap is a data management tl that shuld be used primarily fr Research and Quality Imprvement studies. REDCap must nt be used fr cllecting clinical data used as primary recrds fr a patient s care. The purpse f this dcument is t prvide general guidance n the use f REDCap at UT Suthwestern. Data Management Activities Study Prtcl De$ine data t be cllected Build & Test Database Cllect & Review Data 2. General Infrmatin 2.1 Access t REDCap HSPH emplyees have access t REDCap using the same username/passwrd as their HSPH lgin: Access may be requested fr nn- UTSW emplyees by cntacting wh will prvide instructins t nbard External Cllabratrs. REDCap is a web- based applicatin and can be used frm anywhere, utside the HSPH netwrk and frm any encrypted mbile device (laptp, ipd, ipad). 3

4 2.2 Cmpliance REDCap is designed with built- in features t address cnfidentiality and cmpliance requirements. a. Access cntrl Access is based n the Active Directry at UTSW nly at this time. External users wh request access will be added manually t REDCap. At the prject level, access cntrl is fully cnfigurable: a prject wner can authrize study staff access, as required per IRB prtcl. Identifiers can be flagged and remved frm data exprts, depending n user prfiles. See sectin fr mre details n user rights. b. Audit trail Every peratin perfrmed in REDCap is tracked and can be easily retrieved at the prject level. (See lgging feature in REDCap). c. Centralizatin f data n lcal servers The REDCap applicatin and data are bth hsted n UTSW secure servers. A backup is perfrmed n a nightly basis. 2.3 Training There is n frmal training required t use REDCap but vide tutrials and help text are available within each mdule in REDCap. Als, the Help & FAQ tab in REDCap cntains a lt f useful infrmatin. 2.4 Supprt The REDCap applicatin is develped and deplyed by Vanderbilt University. At UT Suthwestern, Academic Infrmatin Systems (AIS) is respnsible fr the maintenance and the administratin f the system. REDCap verview sessins and hands n labs are ffered thrugh AIS. Cntact fr infrmatin n the next verview sessin. 3. Hw t use REDCap 3.1 Definitin and wrding Arms: grup events int 'arms ; there may be ne r mre arms/grups per prject. Each arm can have as many events as needed. Branching lgic: Branching Lgic may be emplyed when fields/questins need t be hidden fr data entry under certain cnditins. Calendar: prject calendar t help rganize the patients scheduling and keep track f any upcming events. CRF: Case Reprt Frm. Data Dictinary: excel file, cntaining the list f fields f a given prject and their assciated attributes. 4

5 Events: allw fr the utilizatin f data cllectin frms multiple times fr any given prject recrd (ften used when cllecting lngitudinal data). An 'event' may be a tempral event in the curse f a prject, such as a participant visit r a task t be perfrmed. The terms field r variable r questin may be used interchangeably and represent unique items f data t be cllected and analyzed. File repsitry: repsitry that stres and retrieves files and dcuments used fr a prject. Whenever a data exprt is perfrmed, the resulting data and syntax files are als stred in the file repsitry f the prject. Instrument: survey page r data entry frm. Lgging: mdule that lists all changes made t this prject, including data exprts, data changes, and the creatin r deletin f users (audit trail). Prject status: develpment, prductin, draft, inactive and archived. Prject type: single survey r data entry frm(s) r a mix f a single survey / data entry frm(s). Recrd Label: infrmatin/variables added t the unique ID f the study (e.g. pat_id) t help select the right recrd during data entry. Fr example, date f birth r last name can be added as recrd labels when selecting a subject fr data entry. Recrd labels are displayed nly and have n impact when exprting data. 3.2 Prject wrkflw Draft Prtcl Develpment mde Build and test a prject Test data Final Prtc l Prductin mde Enter, review and analyze data Real data Inactive (ptinal) mde View and analyze data N data entry/update Prtcl Amendme nt Draft mde Update prject setup Data activities can cntinue during the update f the setup update Archived mde Prject is clsed Data analysis finalized 5

6 3.3 Build and test a prject Getting Started Prerequisites If cllecting data fr the purpse f human subject s research, review and apprval f the prject by the Institutinal Review Bard is required. If cllecting data fr clinical quality cntrl, apprval by the CQO is required at UT Suthwestern and the CMIO s at Parkland and Children s Medical Center. N apprval is required fr peratinal surveys. Define data t be cllected befre yu start building a prject. The infrmatin that is ging t be defined during this step will determine hw t build the database. Study Prtcl What? Why? Wh? When? Hw? Variables Data entry frm Events / Visits User Rights General recmmendatins: Prtcl determines what data shuld be cllected n the CRF Data that are nt needed shuld nt be cllected: allw fr efficient and cmplete data prcessing, analysis and reprting Avid duplicatin: d nt recrd the same infrmatin int multiple variables fr the same event: e.g. DOB and age Prvide instructins t reduce misinterpretatins Be clear and cncise with data questins 6

7 Prvide units t ensure cmparable values Request minimal free text respnses: prvide pre- defined chices Use Nne and Nt dne t help tracking missing data Determine if data are cllected nce r multiple times during the prject Determine if data are used acrss studies and rganizatins Determine hw data will be cllected: manual key entry, imprted frm Access r ther surce, imprted frm anther study Determine wh will enter data: Patients, Nurses, Study staff 7

8 3.3.2 Build a prject Define a prject type There are three prject types available in REDCap: a. Data cllectin perfrmed nly by study team Data entry frms b. Data cllectin perfrmed nly by subjects / study participants Survey c. Screening phase befre enrlling subjects Survey + Data entry frms (Survey will be used t screen subjects and data entry frms t cllect study data) Nte: the PI name and IRB# must be recrded in REDCap when creating a research prject. There are tw cllectin frmats available fr data entry frms: Classic: ne recrd per patient Lngitudinal: ne recrd per patient per event, with the pssibility f defining multiple arms Create instruments When creating a data entry frms prject in REDCap, a demgraphics frm is autmatically added t the prject. This frm may be mdified r deleted by the prject wner. A given field cannt be used in mre than ne instrument. The instruments are meant t rganize data cllectin nly; they have n impact n the structure f the database r n data extractin. Create instruments and regrup the fields by instrument frm a data cllectin lgic standpint: By mdules: i.e. demgraphics, vitals, medicatin, By type f persns wh cllect data By data acquisitin type: manual data entry r data imprt Regrup identifiers (PHI) n the same instrument t better prtect subject s data In a lngitudinal study, fields that are entered at the same event r within the same arm are gruped tgether. Instruments may be used at multiple events/arms Lngitudinal study example: 8

9 Data cllectin instruments may be als dwnladed frm the public Shared Library f instruments available within REDCap. If a public instrument is used in a given prject, the cntent may nt be mdified Create fields A field is defined by the fllwing attributes: type, label, name, validatin, required, identifier, nte. In additin, a branching lgic can be applied t specify whether r nt a questin will be displayed, depending n values entered in previus questin(s). Branching lgic Field attributes Name: will be clumn name in the exprt file fr data analysis Validatin: t define data type and imprve data quality: frmat will be checked during data entry & data imprt Label: will be displayed n the data entry frm/survey, reprts, PDFs Required?: a value will be required during data entry/data imprt Identifier?: must be set t Yes fr all PHI t be able t de- identify data exprts and limit access t PHI within REDCap Field Nte: t guide data entry Field names 9

10 With sme meaning t identify the cntent easily Avid using Q1, Q2, Q3 Use underscre if necessary D nt use $ r. Examples: Use the wrd date fr all date fields Use the wrd time fr all time fields MUST begin with a letter, therwise data exprts will nt wrk when using SPSS Cannt end with a perid Getting Started Reserved keywrds cannt be used as variable names (ALL, AND, BY, EQ, GE, GT, LE, LT, NE, NOT, OR, TO, and WITH) Shuld be kept shrt whenever pssible (8 12 characters) T avid spelling errrs during prgramming (analysis), T display as clumn headers in reprts and data exprts Repeating measurements Use the same name and add number Example: weight1, weight2, weight3 Available field types: 10

11 date r checkbx yes n true fals Slider / vis 11

12 The cllectin f free text shuld be limited as it is difficult t analyze free text: Use categrical respnses (drp- dwn, radi buttn r checkbx). REDCap will assciate a number (cde) with each answer (label). Cnsider using checkbxes t cllect fields such as medicatins, symptms and cmplicatins. REDCap will create a yes/n clumn in the dataset fr each value that can be checked. Use pre- defined data type (text field with validatin), i.e. yes/n, true/false, number, integer, date, datetime, time, zip cde, , phne. Define range minimum / maximum whenever apprpriate t allw REDCap t perfrm basic data validatin / quality cntrl. All dates in a given study shuld be cllected using the same frmat. Limit the use f calculated fields in REDCap: Calculatins are useful when the resulting value is used t take sme actin regarding the subject Other calculatins shuld be dne utside f REDCap Define user rights The rights f each user wh is granted access t a prject must be defined individually, depending n the user s prfile. The table belw lists the rights that are recmmended per prfile. A given persn may have mre than ne prfile. It is recmmended t check all access rights n a regular basis during the study. Prfile Functin Prject Setup (access rights may be remved nce the prject is in prductin) Calendar x x x Data Exprt Data Imprt x x Data Cmparisn (fr duble data entry) x x Lgging (audit trail) (t be limited) x Data entry Data review Data Analysis X x X File Repsitry x x x x User Rights (t be limited) Data Access Grups x x 12

13 Prfile Functin (t be used when multiple data entry sites) Graphical Data View & Stats Prject Setup (access rights may be remved nce the prject is in prductin) Getting Started Data entry Data review Data Analysis x x x x Data Quality x x x Reprts & Reprt Builder Prject Design & Setup Recrd lcking custmizatin (if used) Lck/Unlck Recrds (if used) *Recrds (Create, Delete, Rename) (D t be limited) x X X x x x C, D, R (fr testing) C R, D x Data Entry Rights (nne, read, edit) Edit (fr testing) Edit Read r Edit Users wh may nt view PHI shuld have access nly t: 1. Calendar 2. De- identified data exprt 3. File repsitry 4. Data Entry Rights sectin: The Nne bx must be checked fr all frms that cntain PHI. The Data entry rights sectin determines the access t data when using the Calendar, building reprts and viewing data with the Graphical Data View tl. Als, if access is given t sme data entry frms, the recrd label (ptinal custmizatin in REDCap) must nt cntain PHI. 5. Data Quality 6. Reprt Builder 7. Graphical Data View & Stats All ther rights shuld be unchecked. 13

14 3.3.3 Test a prject The fllwing tasks must be perfrmed befre mving a prject int prductin! Enter test data using all fields in all instruments and all events t validate instruments and event definitin, branching lgic and calculated fields. Test data must include different cases that will allw testing all scenaris f branching lgic, calculated fields and minimum/maximum ranges. Review test data: pen data entry frms, create reprts, exprt data and send the blank CRF t all c- investigatrs fr review. 14

15 Have a statistician review yur database (if applicable t yur study): Send the data dictinary f yur database t the Statistician. This will clearly cmmunicate any defined branching lgic nt cmmunicated in the raw data file r meta- data frmatting accessible thrugh the "Data Exprt" applicatin. This will als clearly cmmunicate the frmulas frm calculated fields. Send the blank CRF. Have the Statistician perfrm a data exprt t ensure that they d nt extract identifiers. They can give yu feedback regarding the verall design f yur database as well as the definitin f each field. It is imprtant t think thrugh the planned statistical analysis befre cllecting any data. A statistician can make sure that yu are cllecting the fields yu need, in the frmat yu need them in, in rder t perfrm the statistical analyses yu need. 3.4 Mve a prject int prductin mde Once all steps listed in the abve sectins are perfrmed successfully, the prject may be mved int prductin mde. Test data can and shuld be erased autmatically when mving the prject int prductin mde. 3.5 Enter, Review and analyze data Enter data A unique key identifies every recrd: Study ID (aka Pat ID r Subject ID). This key identifier must be the first questin n the first frm (r survey) since REDCap uses this identifier as the key variable t link all frms/events fr a particular subject uses it. If multiple sites are invlved in a study, it is recmmended t use cnventins in rder t grup subjects by site: Example: 1 digit fr the site and 3 digits fr the subject number. Site 1, subject 1: study Id = 1001 Site 2, subject 1: study Id = 2001 Data can be key- entered int REDCap, using regular data entry via Data Entry Frms. Duble data entry is an ptin available in REDCap. When this ptin is enabled, tw data entry peple will enter data, but instead f saving their data as nrmal, the Study ID (r unique recrd identifier) will have either a "- - 1" r "- - 2" appended t it, thus marking it as the recrd entered by data entry persn 1 r 2. This is hw the data entry peple can enter data fr the same subject/patient withut having a duplicate recrd. Because all the recrds entered by the tw users will end in the "- - #" frmat, thse users can nly view the data that they themselves have entered. The "- - #" frmat n the recrds are hidden frm thse tw users, s t them everything appears as it nrmally wuld. Hwever, Reviewers will be able t see the "- - #" appended t the recrds when viewing them. When Reviewers chse t merge the tw recrds entered by the data entry peple, the new "third" 15

16 recrd is saved withut the "- - #" appended t the end f the recrd name. The duble data entry feature can be turn n by the REDCap Administratr nly. Data can be imprted int REDCap frm a CSV file, using the data imprt tl. REDCap generates a template with all clumns. Data must be cpied int this template; clumns may be remved but the first clumn must always be kept (e.g. study_id). During data imprt, data can be added r mdified but cannt be deleted Review data The data review shuld start at the beginning f data cllectin t detect any ptential data entry errrs and t update data entry instructins, if needed. There are different tls available in REDCap t review data: a. Autmatic checks during data entry r data imprt: REDCap will check autmatically during data entry r data imprt fr crrect frmatting f dates, times, numbers, ZIP cdes, addresses and missing values fr required fields. b. Data review tracking: each data entry frm has a status that can be used t track the prgress f data entry and/r data review: Incmplete, Unverified and Cmplete. In additin, the Lck/Unlck feature can be used t prevent accidental data mdificatin r deletin. The e- signature is als an ptin that can serve as the equivalent f a handwritten signature. Example f use: Nte: the use f these tracking tls can be custmized fr each data entry frm and prject, depending n the needs f the prject. c. Reprt Builder: will allw users t create, save, exprt and print custmized data reprts. Once a reprt is saved, all users wh are granted access t the prject and the Reprt Builder mdule f the prject can see it. Fr example, a reprt can be created t check the chrnlgical rders f dates acrss events. 16

17 d. PDF: data fr ne r all recrds may be dwnladed int a single PDF file. Cntains the actual page frmat as seen n the data entry page r survey Includes all data r data frm a single instrument May be used if data need t be shared within a shrt time perid. Getting Started e. Graphical data view and stats This mdule can display any prject data (numeric and cded data) in aggregate graphical frmat and as descriptive statistics. Example: If clicking any f the pints n the plt, the data entry frm f that exact recrd will pen. e. Data Exprts: data can be exprted in Excel Data Exprts in Excel frmat must be used as a tl fr reviewing data and nt as a data destinatin. f. Data Quality mdule The aim f this mdule is t help quickly find discrepancies and errrs in prject data. This mdule cntains rules that can be custmized fr the prject; these rules can be executed at any time during the study. Users can exclude any results that they d nt wish t see in future results. When data review is finalized, the prject may be mved int inactive mde: can query/view data but cannt add/mdify/delete data. The database is ready fr statistical analysis Analyze data The data exprt functin will allw exprting data in varius statistical frmats, with the ptin t select all data r partial data. Frmats available are: SPSS, SAS, R, STATA. The Send- it functin in REDCap can 17

18 be used t send files that cntain sensitive data. Send- It is a secure data transfer applicatin that allws users t uplad a file (up t 260 MB in size) and then allws multiple recipients t dwnlad the file in a secure manner. Each recipient will receive an cntaining a unique dwnlad URL, alng with a secnd fllw- up with the passwrd fr dwnlading the file (fr greater security). The file will be stred securely and then later remved frm the server after the specified expiratin date. Send- It is the perfect slutin fr anyne wanting t send files that are t large fr attachments r that cntain sensitive data De- identificatin methds fr data exprting REDCap prvides advanced de- identificatin ptins that can be ptinally used when exprting data, such as remving knwn Identifier fields, remving invalidated text fields, ntes fields, r date fields, date shifting and hashing f the recrd names. These ptins prvide greater security and data prtectin when a user is exprting sensitive data ut f REDCap. Date shifting: As part f the de- identificatin ptins in REDCap, all dates in the database may be shifted s that they d nt reflect the actual dates. If the ptin t have all dates shifted is chsen, they will be shifted by a cnsistent length f time fr each recrd, thus preserving the interval between dates. Date shifting leaves the database recrd intact and will nt affect the actual saved dates in the database. The shifted dates will always be the same fr each recrd when perfrming a data exprt. The dates are shifted back in time up t 364 days, in which the shifted value is based n the Study ID using a cmplex algrithm. Because the shifted value is based n the recrd name, the amunt that dates are shifted is unique fr each recrd, but the shifted amunt remains the same within each recrd t maintain internal cnsistency. Date shifting prevents any dates frm being used as identifiers fr each database recrd while preserving the interval between dates. 3.6 Clse a prject Once the data analysis is cmplete, the prject in REDCap must be mved int archive mde. This will take the prject ffline, and yu and ther users will n lnger be able t access it nrmally. The prject can be brught back nline at any time after being archived by returning t this page in this prject. It is gd practice t remve all user rights frm the prject except fr ne user because if the prject needs t be put back in prductin status, the access will be limited t ne persn. We d like t acknwledge Children s Hspital f Philadelphia, Center fr Bimedical Infrmatics fr the riginal dc. template. 18

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