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
Aimee Basile Project Lead Industry
Todd Bazin Co-Lead Biogen

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)
Shalini Dwivedi Kinapse
Shannon Labout datasciencesolutionsllc shannonlabout (at) datasciencesolutionsllc
Sharon Weller Lilly weller_sharon_m (at)
Nancy Brucken Syneoshealth Nancy Brucken (at)
Kim Musgrave Amgen Kim Musgrave (at)
Melvin Munsaka AbbVie Melvin Munsaka (at)
Trisha Simpson UCB Trisha Simpson (at)
Mary Nilsson Lilly Mary Nilsson (at)
Jennifer Alf Astellas Jennifer Alf (at)
Joanne Zhou GSK Joanne c zhou (at)
Pranab Kumar Mitra Merck pranab mitra (at)
Alan Shapiro FDA Alan Shapiro (at)
Titania Dumas-Roberson Unither Titania Dumas-Roberson (at)
Kathy Taylor Unither

Project Updates

July 2019

Under the new leadership of Aimee, the PHUSE Best Practices for Data Collection Instructions Working Group was started in 2017 with the objective to develop detailed collection recommendations that would supplement existing CDASH completion instructions, as well as leverage the recommendations and code developed by the PHUSE Standard Analysis and Code Sharing Working Group. While there are several domains that will benefit from comprehensive data collection guidance, the Best Practices for Data Collection Working Group has linked with the Standard Analysis and Code Sharing Working Group to tackle the adverse events domain in order to support their deliverable for standard treatment-emergent adverse event displays. Based on this collaboration, we have a renewed resolve to complete our work, specifically around the collection of adverse events. We are asking for volunteers to provide support for identifying the myriad ways adverse event data are collected (using surveys and interviews), and subsequently formulating a recommendation that supports both efficient data collection and the needs for analysis and displays.

If you are interested in joining this project contact working groups (at)

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 TBD
Final White Paper presented at CSS TBD

Project Content and Activities

Meeting Minutes