Informed Consent Tracking Through DataFax

Transcription

1 Informed Consent Tracking Through DataFax Vaishali Krishnan U.S. Department of Veterans Affairs Cooperative Studies Program Coordinating Center Menlo Park, CA Background: IC Review & Tracking Standard process across studies Collect & review Informed Consent (IC) Required elements: pages, signatures, dates, initials, HIPAA authorization Notify site of problems Track status of problems and work with site until resolution 1

2 Background: IC Tracking Manual tracking: phone, Not standard across studies Not standard across PM personnel Worked OK for small, simple studies Background: IC Tracking Large studies: # of patients, # of study sites Complex studies: multiple IC per patient Screening, Randomization Protocol changes requiring re-consent Onerous, time-consuming 2

3 DataFax to the Rescue Why DataFax? Easy to log data with Raw Data Entry (RDE) Easy to check for problems with Edit Checks Easy to track problems through QC Report Process Test DF s utility, expanded beyond clinical data model 3

4 Informed Consent in DataFax SITE Obtains IC from patient Ships hardcopy to PM NEW PROJECT MANAGEMENT Receives hardcopy of IC Logs into DF IC study using RDE DataFax: IC Logging & Tracking Convert IC review into DF plate all pages Q1. Are all pages present? pt signature Q2. Is patient signature present? consent date Consent Date: 01 / 15 / 2007 patient Patient ID: Standard template across studies Different visits for multiple IC per patient 4

5 DataFax: IC Logging & Tracking Single DF study to log ICs for all clinical studies Separate plate for each study Main DF study for QC Process Same plate in Main study Setup as in IC study 5

6 DF Toolbox Setup: IC Study vs. Main Studies IC STUDY: #080 plate 400 = Heart Study #1 plate 450 = Cancer Study #2 plate 499 = Psych Study #3 etc. HEART STUDY: #1 plates : clinical data plate 400 = IC plate CANCER STUDY: #2 plates 1 50: clinical data plate 450 = IC plate PSYCH STUDY: #3 plates : clinical data plate 499 = IC plate 6

7 DataFax: IC Logging & Tracking Why Separate IC Study? Secure PHI - separate from clinical data Why Do QC Process in Main Study? Maintain separation of PM and DM IC study - Centers db Nightmare! IC data checks against Main study data 7

8 Informed Consent in DataFax Study Site: Sends IC hardcopy to PM PM, IC Study: Logs IC data using RDE 8

9 Data Export & Import Export clean data out of IC study Modify data: change study number drop SSN assign raster number Import data into Main study Informed Consent in DataFax Study Site: Sends IC hardcopy to PM PM, IC Study: Logs IC data using RDE DM: IC study data Main study Study Site: Resolve problems and DM, Main Study: Batch edit checks to add or resolve QCs for IC problems DM, Main Study: QC Reports to site 9

10 Used by Project Management, limited DF training Log IC by raw data entry (RDE) Disabled CRF image window Retrieval Tasks for Build Set By Data Fields Pre-defined RDE builds using DFraw_map IC / study selection ease Avoids illegal plate/visit combinations (i.e. study/ic type) DFmissing_map: IC Study Coding for acceptable missing data Coding for missing values requiring QC to site 10

11 Same IC Study v. Main Study plate number all data points except SSN Different IC study has SSN, Main Study does not Configuration: IC Study does not have Visit Map, Page Map Conditional Maps Centers Database IC problem QCs for site QCR in Main Study only Internal logging inconsistency checks in IC Study only 11

12 Edit Checks: IC Study All checks are within a single study I.e., not checking across different plate #s Inconsistent responses by logger dfwarning pop-up box, on field exit and plate exit Makes a field illegal (red) if inconsistent Cannot mark record clean Not imported to Main 12

13 Edit Checks: IC Study SSN checks Different IDs with same SSN Same IDs with different SSN SSN code populated via EC, coding for errors Batch Edit Checks: Main Study Add QC, Y/N data = No no unresolved QC (no active QC) Resolve QC, Y/N data = Yes active QC exists Coded as missing, add QC ID and visit checks SSN codes translate into specific QCs 13

14 QC Report: Q&A Section PATIENT Form: Visit Pg # PROBLEM IC: Pt. Part 1 Question 2 = 2 (Missing Value) The patient initials are missing from the following page(s) of the Informed Consent: IC: CG. Part 1 Question 4 = 2 (Missing Value) The signature of the PI is missing (the signature line is blank) IC: CG. Part 1 Question 8 = 2 (Missing Value) On the signature page, the following signature(s) was/were not dated: PI Stable Current Functionality Using full log/track process in 2 studies Another one to start soon Logging only in one study 14

15 New aspects of DF Lessons Learned Importing records which require fake DFraster Auto add QCs: can add QC, but cannot change status from clean to dirty import all records as dirty Auto resolution of QCs Labor intensive Complex process, involving PM, DM, SP, IT Personnel change Limited resources: staff and time 15

16 Sleeves Rolled Up, Hands Dirtied Joanna Thorgrimsson Andres Busette Beverly Ventura Anjali Kukde Meredith Miller Lauren Uyeda Kevin Chow Tracey Tibbetts Thank You Contact info: x