Considerations on the use of Mobile eCOA/ePRO Technology in Clinical Trials

I’m going to be providing this training internally at my company. I’m wondering if it is of interest externally as well….

The use of Electronic Clinical Outcome Assessments (eCOA) or Electronic Patient Reported Outcomes (ePRO) via mobile devices (smart phones, tablets, etc.) has been evolving and expanding in recent years. As an industry, we’ve conquered some of the early challenges experienced with the use of these devices in the clinic, usually on lower risk data and often with a paper backup process in place. However, as we move forward with increasingly complex devices and data collection schemas for higher risk efficacy/safety data the stakes have raised. Adding to this risk is the advent of adaptive trial design and increased time pressures in clinical research. New challenges have emerged that need to be considered and mitigated as we move forward with the promise these technologies hold in the improvement of trial design and data quality. This training is designed to enhance the understanding of professionals in all areas of clinical research (Clinical Operations, Monitoring, Clinical Scientists, Data Management, Biostats, Medical Writing, etc.)  and the service organizations that support them (IT, Procurement, Contract Management, Quality, RA, Safety, etc.) including Senior Leadership who drive the initiatives to adopt best-in-class tools and design.

Thoughts?

~TJK

 

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A Summary of the New MHRA ‘GXP’ Data Integrity Guidance and Definitions – March 2018

A Summary of the New MHRA ‘GXP’ Data Integrity Guidance and Definitions – March 2018

For over 20 years, there have been Health Authority regulations governing the use of Electronic Records and Electronic Signatures (eReS) for GxP purposes. These regulations (the US part 11, the EU Annex 11, and their ilk globally) are arguably among the most elegant, concise, and consistent across jurisdictions (with differences mostly limited to context and emphasis rather than substance).

That being said, there has been a considerable amount of confusion in interpreting and applying the eReS regulations as both the Regulators and those in Industry have evolved their understanding of these regulations as the various guidance documents have emerged, been rescinded, revised, re-issued, clarified, etc.

This latest guidance document (which can and should be read in its entirety here (21 pages): https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHR), is very mature in its outlook and takes what has come before and builds upon it. The result adds a huge amount of clarity by specifically expounding on the general theme “This what we want, yes it means exactly that, and yes we understand the practical considerations and resource impact of what we want”.

Some key items in the guidance include:

  • Its application is intended across all GxP areas (Excepting Medical Devices – which I found interesting)
  • The principles of data integrity (which are separate from those of data quality) are meant to be adaptable, and are designed to evolve with Technology and promote a risk-based approach.
  • The non-technical aspects of data integrity are addressed, including the organizational responsibility to create a culture and environment (controls) that ensures that data is complete, consistent, and accurate in all forms (They focus on the oft neglected idea that PEOPLE are part of the process).
  • They revisit both ALOCA and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available. They go on to clarify that these two acronyms are differing ways of explaining the same expectations.
  • Differing paper, electronic, hybrid scenarios are discussed as are the ideas around Risk, Risk mitigation, and documentation around both. Warnings are made about poor organizational controls and the over-reliance on a system’s validated state.
  • Challenges and considerations around designing data processes and controls are discussed in some detail.
  • Key definitions are explained in some detail for: Data, ALCOA, Raw = Source Data, Metadata, Data Integrity, Data Governance, Data Lifecycle, Recording & collection of data, Data transfer & migration, Data Processing, Data Exclusion, True Copy, Transactional data, Audit Trail, Reconstructability, Electronic Signatures, Data review and approval, Data Retention/Backup/Archival, System Access, the Admin Role, Validation, and IT Suppliers including Cloud providers).

~TJK

Novartis goes digital with FocalView for ophthalmology clinical trials

(Image: Getty/demaerre)May you live in interesting times… A colleague flagged this for me. I’ll be very interested in the particulars of how this all works going forward. #ItsAllAboutApps

 

~TJK

Source: Novartis goes digital with FocalView for ophthalmology clinical trials

New Proposed Auditing Course: Considerations for an eData Quality Audit Program

We’ve submitted this course proposal for the April SQA Quality College in Anaheim. Feedback has been good, but even if it isn’t picked up for this venue…it will eventually happen *somewhere*:

Instructors: Timothy J. Kuhn and Conrad Kawaguchi

Target Audience: Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.

 Course Objectives

• Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.

• List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)

• Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)

• Define and list the desired skill set for the eData Audit Team

• Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes – AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.

Course Description: Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT saavy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate “what to look for” for a variety of audits, both technology-focused and more conventional areas in which technology has “encroached”.

 

~TJK

WHO: GOOD DATA AND RECORD MANAGEMENT PRACTICES

Some good stuff in this guidance….particularly the bit on True copies…..

GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES (SEPTEMBER 2015) DRAFT FOR COMMENT

True copy: A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.

Full Guidance:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

Vaccines, Real Medicine

I’m so tired of #Homeopathabullshit….

~TJK

Part 11 Cloud Compliance Course

 Timothy J. Kuhn

Timothy J. Kuhn: I’m not affiliated with the provider of the course as you may have surmised. I’ve been looking for a course for some of my team members and this came up in my feed so I thought I’d share. It looks useful; has anyone else taken it?

Best,

TJK

“21 CFR Part 11 Compliance for SaaS/Cloud Applications” has been pre-approved by RAPS as eligible for up to 12 credits

Key Focus:

Agenda: http://www.complianceonline.com/21-cfr-part-11-compliance-for-saas-cloud-applications-seminar-training-80202SEM-prdsm?channel=Nisha_OB

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