Forms Development and RAVE

Transcription

1 Forms Deveopment and RAVE Shauna Himan, MS Mayo-Rochester, MN May 11 th, 2017

2 Presentation Objectives Provide the Aiance high eve process for deveoping forms (both paper and eectronic) Provide a basic understanding for how the Data Capture System (Medidata Rave) functions Provide key eements in successfu data coection Provide key eements in efficient Rave buids

3 Forms Deveopment Process Begins with a stabe Protoco (draft #3) Schema Eigibiity Criteria Registration/Randomization Treatment Disease Evauation Study Caendar

4 Forms Deveopment Process Study Deveoper (SD) seects the appropriate paper CRF tempates, and creates any study specific forms based on review of the protoco Eigibiity Checkist Off Treatment On-Study Form Withdrawa of consent Treatment Form Lost to foow-up AE Form New Primary Patient Status Form Treatment indicator Disease/vita status Indicators for the roout of additiona forms

5 Forms Deveopment Process Study team reviews the initia draft, answers SD questions and provides feedback to ensure the CRF content is consistent with the protoco endpoints and meets data coection needs Study Team Members PI: Principa Investigator Stat: Statistician SPA: Statistica Programmer Anayst DM: Data Manager PC: Protoco Coordinator SD updates the pcrfs based on study team feedback Study team provides fina approva (documented via the Statistician) Forms sent for curation (check that NCI standards are being used) pcrfs are frozen and ecrf buid begins

6 ecrf Deveopment Aiance Navigation Phiosophy Add foders one visit/cyce at a time based on data entered for the current visit/cyce Five phases of data coection Baseine Treatment Off Treatment Cinica Foow-up: more rigorous data coection, typicay coecting AE and Measurement data Surviva Foow-up: ess rigorous data coection, primariy capturing ate AE, progression, new primary and vita status

7 Surviva and Disease Status Foow Up (repeat as needed) Genera navigation Baseine Treatment (repeat as needed) Off Treatment Cinica Foow Up (repeat as needed)

8 ecrf Deveopment Patient Pathway Diagram (PPD) Study team communication too and specifications used for database design Visua picture of patient pathways for data submission Incudes a pathways not just the expected path Necessary for: Foder and form ro-out Tracking (foder target and overdue dates)

9 ecrf Deveopment Forms Tracking Target dates are set indicating when forms within the foder are expected based on data entry and tria requirements. The timeframes* for designating forms overdue Baseine: 15 days from target date Treatment: 15 days from target date Foow-up: 30 days from target date *NCI Standards for NCTN trias

10 Dispay of Foders in Rave Exampe of Rave subject homepage List of a foders Visit foders with caendaring tracking Target Dates Actua visits dates based on data entry

11 ecrf Devopment Study Buid Team & Process High Leve Process for Deveoping a Tria in Rave Panning Buiding Testing Production Tasks Project Panning: request project setup, identify timeines and team members Requirements Gathering: incudes pcrf review, PPD, and DSS deveopment Buid/Copy/Insta and Unit Test: ecrfs, reusabe edit checks and custom functions, and study specific data vaidations Vaidate, test and verify the buid Activation of tria in Rave incuding Rave readiness signoff Study Team PI, Stat, SPA, DM PC, CRA* Stat, SPA, DM Stat, SPA, DM, DMS, CM Stat, SPA, PC, DM Rave Buid Team SD SD SD SD *optiona members

12 Rave Feature: Roe Specific Task Summary Data Manager Roe Site roe

13 Rave Feature: Fu Audit Trai Most current events are on the top User responsibe for event Date and time of event

14 Rave Feature: Forms Tracking Overdue forms are dispayed in the Rave Task Summary by the cock icon A target and overdue data is configurabe at the study eve Expected and overdue materia (forms & queries) reports avaiabe to sites on Aiance website

15 Rave Feature: Forms Tracking Exampe Overdue Materia Report

16 Rave Feature Queries Rave aows for both system-generated and manua-generated queries System-generated queries fire at the time a form is saved (system fied edits and configurabe edits) Manua queries are created by seected roes and can be done at any time Data Manager Centra Monitor

17 Rave Feature Queries Answering Queries Sites can respond to queries by: Modifying the data in the fied Provide an expanation in the user response box (freetext) if data cannot be entered

18 Database Design Queries Site gets immediate feedback (upon form save)

19 Cinica Reviews Faciitated in Rave Eigibiity Reviews The DM wi be fagged for eigibiity review when a study identified forms are entered by the site For exampe: On-study Radiographic Imaging Assessment: Baseine Supporting Documentation: Baseine Patient Status: Baseine The DM competes the eigibiity review DM notifies Study Chair in the case of questionabe or ineigibe patients via checkbox on the eigibiity form and upoad the necessary reports Study Chair wi review via Rave If there is a disagreement, the DM is notified for arbitration

20 Eigibiity Review Form Competed by the Study Chair

21 Cinica Review Faciitated in Rave Case Evauation (endpoint) Review Medica review of key cinica data conducted when a patient meets the primary study endpoint (study defined): For exampe Progression Death without progression Foow-up competed without events above Withdraw consent for a foow-up without events above Confirmed ost to foow-up without events above

22 Cinica Review Faciitated in Rave Case Evauation Process Data Manger (DM) is fagged to review within Rave DM reviews data submitted for competeness & accuracy DM runs the endpoint review report and attaches it to a form within Rave DM sends cases to the Study Chair (SC) in Rave foowing Aiance Poicy First 100 pts, every 10 thereafter up to 300 and any probem cases SC is fagged to their review via an e-mai and query SC reviews data in Patient Summary Report and competes the Case Evauation form (in Rave) SC wi have access to CRFs for Phase I or II trias SC wi not have access to CRFs for Phase III trias DM reviews discrepancies or other probems noted by the SC and queries the site, if necessary If there is a disagreement, the DM is notified for arbitration

23 Case Evauation Form Competed by the Study Chair

24 Keys Eements of Successfu Data Coection Less is more Data coection is costy Coecting unnecessary data takes time and resources away from critica data eements A data coected shoud be inked to a study aim The number of soicited Adverse Events incuded significanty increases data coection and data management time. It aso decreases the response time in Rave. Target < 10 whenever possibe

25 AE Exampe

26 AE Exampe Dynamic grade drop down that ony dispays grades appropriate for the seected AE term

27 Key Eements of Successfu Data Coection Case Report Forms are Critica A ot of resources goes into deveoping the protoco, if the same eve of effort is not put into the design of the case report forms, tria objectives wi not be met Study Chair invovement is Crucia SD are not disease or study experts, they need your input and review It takes considerabe resources to make changes after protoco activation (avoid migrations)

28 Key Eements of Efficient Rave Buids Use the Standards whenever possibe Reduces buid and testing time Reduces curation time Faciitates standardized outputs and reporting Reduces data entry errors with famiiarity of ecrf design by end users

29 Questions???