CRA Workbench: Access DATA SUBMISSION PRE-RAVE & RAVE. Clinical Trials Training Course Data Submission. Pre-RAVE

Transcription

1 DATA SUBMISSION PRE-RAVE & RAVE JACQUELINE SCURLOCK & SEAN O BRYAN CLINICAL RESEARCH DATA COORDINATORS SDMC 1 Pre-RAVE Also known as: Chart Manager The Legacy System CRA Workbench Used for studies activated prior to April 2012 Currently in use for ½ of all SWOG studies 2 CRA Workbench: Access SWOG.org Member Logon (CTEP credentials) Member Resources CRA Workbench 3 1

2 CRA Workbench >> Pre-Rave Data Submission 4 : Lookup Up to 4 specific patients List of patients By Study By following CTEP Investigator ID By CTEP institution ID Filters Only show alive patients Only show patients with unresolved expectations Only show patients with outstanding queries 5 Lookup results select individual patient chart This is arranged by patient number 6 2

3 CRA Workbench: Organization Default tab = Patient Info Go to Forms tab for forms 7 Chart Organization Forms tab has up to 5 sub-tabs 8 Chart Forms 9 3

4 Editable Version 10 Confirmation Page 11 CRA Workbench: Amended Data Forms listed as a hyperlink can be amended online 12 4

5 CRA Workbench: Amended Data Confirmations will indicate if the data are amendable online or not 13 Not Amendable Online Older studies may have some forms that are not amendable online Instead, print the confirmation, make changes, and fax to the SDMC 14 Complete applicable fields on the form Button options o Submit: saves data and runs edit checks o Save without submitting: saves data but does not run edit checks o Cancel/Close form: closes form without saving data (warns first) 15 5

6 Edits Check Errors (red light) Must be fixed before form can be submitted 16 Edit Check Warnings (yellow light) must be acknowledged before form can be submitted 17 Edits Check Green light means successful submission 18 6

7 Query Resolution Data Coordinators evaluate submitted data for: Eligibility Study compliance Response assessment Off-treatment decision Serious adverse events (SAE) Death circumstances Queries are written to clarify or correct missing or inconsistent data 19 Query Resolution Queries can be found in two places Pre-RAVE >> Queries tab Patient-specific queries Reports >> Query Reports Site-specific reports (across all studies and patients) 20 Pre- RAVE >> Queries tab 21 7

8 Reports >> Query Reports 22 Switching to Rave 23 Rave: Overview Access Organization Query Resolution/Amending Data Resources 24 8

9 Rave: Access Invitations are sent to join IRB-approved study Sent to Rave CRA role on SWOG Roster Only Head CRAs identified as Rave CRA by default Request role modifications from Head CRA Logon using CTEP IAM username and password Same username/password as OPEN Accept invitations to studies Satisfy elearning requirements 25 Rave: Access This is the imedidata portal to all RAVE studies you have access to, both SWOG & non-swog. 26 Rave: Organization Rave is organized by study There are no cross-study reports / functions or ways to view information about more than one study at a time in RAVE. Study >> Site >> Subject >> Folders >> Forms 27 9

10 Rave: Organization All pts this site has registered to this study. Task Summary, which shows the outstanding tasks. 28 Rave: Organization Tasks, folders, & forms specific to this particular patient. 29 Rave: Organization Forms in Rave will look different from their paper CRF counterparts Rave allows us to show you only the folders, forms, or even parts of a form that apply to your patient Some Rave forms may not appear until certain questions are answered a certain way 30 10

11 Rave: Organization Rave: Organization Rave Form Display document Found on the swog.org study page in the Master Forms Set Lists all forms and when they appear 33 11

12 Rave: Parts of a Form Logline Fields Source documentation Conditional Field Display Sticky Notes 34 Rave: 35 Rave: Parts of a Form Saving & Resolution After Save, static message appears at the top of the form After saving form, SCROLL DOWN to make sure all your fields have green checkmarks 36 12

13 Rave: Logline fields Used to capture data about an unknown number of events Can add as many loglines as needed Can inactivate (not delete) any added in error Save form after adding & completing each logline Make sure there are no non-conformant data error messages on the log line after saving. 37 Rave: Paper Version: 38 Rave: As you can see, one line is available to start. You can add more on an as-needed basis by clicking the Add a new log line button

14 Rave: If you want to remove a log line, you can click the inactivate button, which will prompt you to specify which line you want removed, & the data will be lined out. 40 Rave: Source documentation Rave has a special field that allows the upload of electronic documents Add a new log line for multiple reports (if needed) 41 Rave: Source documentation (cont.) Document MUST have patient name, SSN and address data thoroughly redacted Prefer PDFs Do not combine different documents as a single PDF

15 Rave: 43 Rave: Conditional Field Display Rave is programmed to show certain fields depending on the data that is entered. Example: A question regarding Supplemental Agents might ask if the patient has taken any supplemental meds since the previous visit. If answered yes, Additional questions pertaining to the selected agent(s) appear after saving form

16 46 Rave: Sticky notes Used for reminders Just need to check the acknowledge box and save the form Will show up in Task Summary until acknowledged Sticky notes do not affect green checkmarks

17 Rave: Query Resolution/ Amending Data System queries are generated by Rave If no response box present, must change data to resolve If response box present, may type response, rather than changing the data All system queries must be resolved before the data are sent to SWOG Expectations resolved by next business day 49 System Query Example 50 System Query Example 51 17

18 System Query Example 52 Rave: Query Resolution/ Amending Data Special System Query: Save without submitting The bottom of every form has a Save without submitting checkbox An edit check requiring the box to be unchecked will fire a query Edit checks will run on other fields as well

19 55 Rave: Query Resolution/ Amending Data Manual queries are written by a Data Coordinator If no response box present, must change data to resolve If response box present, MUST type response, instead of or in addition to changing data 56 Manual Query Example 57 19

20 Manual Query Example 58 Manual Query Example 59 Rave: Query Resolution/ Amending Data Both system queries and manual queries will be listed in the Task Summary Study Level Site Level Subject Level 60 20

21 CRA Workbench Reports >> Query Reports 61 Rave: Resources CRA Workbench Rave Studies YES Link to OPEN Link to Rave Link to Specimen Tracking Expectation report IPR report Queries report Ineligible patients report Training slides/documents Rave Studies NO Data/Form Submission Query resolution 62 Rave: Resources CTSU Help Desk 9:30am 8:30pm ET Multiple Resources Links provided in Rave at the bottom left, including CTSU contact information 63 21

22 QUESTIONS? 64 22