eCF "BoF" Round table: "A Chat about eCOA"

Birds-of-a-Feather Round Table Discussion:  “A Chat about eCOA”

Date:  Wed, 9-July-2025     Duration: One hour

Facilitators:    Leigh Bobowski: Pfizer, Director, Group Lead, CDS, Clinical Data and Information Sciences

                          Siva Bala: Pfizer, eCOA Lead (Patient Data Strategies), Clinical Data and Information Sciences

Time – UTC: 1400 (NYC: 10am, Brussels 4pm, Beijing: 10pm) We apologize for the inconvenient time in some time zones. Please feel free to forward this invitation to your colleagues within your organization.

Background: eClinical Forum Birds-of-a-Feather webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic: This session is not intended to provide firm answers to the below questions. It is about exchanging views with other participants and gaining insights into the different challenges and needs. This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. To encourage candid discussion, we will not be recording this session.

Continuing the discussions started at the Spring workshops ... we will be discussing:

 Insights on the standardization of instruments within your organization ...

• Experiences with implementing eCOA builds in-house

  • Experiences/Challenges with Device provisioning
  • Experiences/Challenges with development of Site portals

• Experiences with MFA : Any patient feedback on MFA vs simple login (PIN or PWD)

Experiences with implementation of 'Reason Not Performed' (QSREASND) in QS domains as outlined in Section 4.1.2.2 of the "Handling of Missing Data in Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory" and Section 3.1.1.2 of the "Handling of Missing PRO Data Submitting Patient-Reported Outcome Data in Cancer Clinical Trials."

• How are you capturing QSREASND data? Is this incorporated in the Case Report Form (CRF) or within the electronic Clinical Outcome Assessment (eCOA) platform?
• Have our vendors been able and willing to add 'Reason Not Performed' (QSREASND) if it wasn't already included in the QS?

• Any considerations and learnings you can share from your experience with this implementation ?

Open To: Staff from eClinical Forum member companies gratis  (If your organisation is not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )

eCF Members can register here:  eCF BoF Round-Table: "A Chat about eCOA"