Best Practices for Data Collection Instructions

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Project Overview

CDISC’s CDASH team provides high level completion instructions related to the core data collection modules. The PhUSE Standard Analysis and Code Sharing Working Group has developed recommended displays (ie, tables and figures) and associated code for use for analysis for data common across therapeutic areas. For some data domains (e.g., adverse events, medical history, concomitant medications, study disposition, pregnancy, reasons for permanent discontinuations from study treatment), having more consistent collection instructions at a more detailed level will potentially lead to increased efficiency (site personnel won't have to learn as many collection methods) and fewer queries (less confusion by site personnel), and will enable sponsors to fully leverage the recommendations and code from the PhUSE Standard Analyses and Code Sharing Working Group. Collection and associated instructions may vary depending on whether the study is early vs late stage, as discussed in the February 2016 FDA guidance ('Determining the extent of safety data collection needed in late stage pre-market and post-approval clinical investigations'). However, reducing the extent of variation would be beneficial for medical research.

This project team will network with CDISC and the Standard Analyses and Code Sharing Working Group to ensure alignment.

Project Deliverables

The initial scope of the project is to create a white paper documenting challenges and gaps with the CDASH CRF completion as well as recommendations for a future version of CDASH. The white paper will be provided to CDISC for their consideration. The project team will focus on the following domains: Adverse Events, Medical History, Concomitant Medications, Pregnancy, and Reasons for Treatment and Study Discontinuation. The team will assess the opportunity to address other domains after the white paper is completed.

Project Leadership Team

Name Role Organization E-mail
Todd Bazin Project Leader Biogen todd.bazin (at)

Project Members

Name Organization E-mail
Alec Vardy Jazz Pharma alec.vardy (at)
Aparna Kulkarni Novartis aparnakulkarni616 (at)
Cathy Bezek Astellas Cathy.Bezek (at)
Charity Quick RHO World Charity_Quick (at)
Elizabeth Langevin Takeda Elizabeth.Langevin (at)
Farhan (CJ) Hameed Pfizer Farhan.Hameed (at)
Jeannine Hughes Boehringer-Ingelheim Jeannine.Hughes (at)
Jennifer Showalter Lilly jshowalter (at)
Kit Howard CDISC khoward (at)
Lisa Houterloot PRA Health Sciences HouterlootLisa (at)
Russ Newhouse Lilly newhouse_russell_d (at)
Shannon Labout CDISC slabout (at)
Sharon Weller Lilly weller_sharon_m (at)
Tina Lambert Astellas Tina.Lambert (at)

Project Updates

November 2018

This Project is working in collaboration with the Standard Analyses & Code Sharing White Papers project.

The scope for this first combined deliverable is to simply report the current variations in AE collection and analysis and why such variation exists.

Objectives and Timelines

Objective Timeline
Draft White Paper on what data is collected in Adverse Events?, what collection instructions are define related to AE data for Investigational site Personnel, How is the Treatment Emergence defined and calculated Q22019
Final White Paper presented at CSS June 2019

Project Content and Activities

Meeting Minutes