Best Practices for Data Collection Instructions
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.
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
|Todd Bazin||Project Leader||Biogen||todd.bazin (at) biogen.com|
|Alec Vardy||Jazz Pharma||alec.vardy (at) jazzpharma.com|
|Aparna Kulkarni||Novartis||aparnakulkarni616 (at) gmail.com|
|Cathy Bezek||Astellas||Cathy.Bezek (at) astellas.com|
|Charity Quick||RHO World||Charity_Quick (at) rhoworld.com|
|Elizabeth Langevin||Takeda||Elizabeth.Langevin (at) Takeda.com|
|Farhan (CJ) Hameed||Pfizer||Farhan.Hameed (at) pfizer.com|
|Jeannine Hughes||Boehringer-Ingelheim||Jeannine.Hughes (at) boehringer-ingelheim.com|
|Jennifer Showalter||Lilly||jshowalter (at) lilly.com|
|Kit Howard||CDISC||khoward (at) cdisc.com|
|Lisa Houterloot||PRA Health Sciences||HouterlootLisa (at) prahs.com|
|Russ Newhouse||Lilly||newhouse_russell_d (at) lilly.com|
|Shannon Labout||CDISC||slabout (at) cdisc.org|
|Sharon Weller||Lilly||weller_sharon_m (at) lilly.com|
|Tina Lambert||Astellas||Tina.Lambert (at) astellas.com|
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
|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
- 19 May 2017 Meeting Minutes
- 02 Jun 2017 Meeting Minutes
- 23 Jun 2017 Meeting Minutes
- 07 Jul 2017 Meeting Minutes
- 04 Aug 2017 Meeting Minutes
- 08 Sep 2017 Meeting Minutes
- 15 Sep 2017 Meeting Minutes
- 03 Nov 2017 Meeting Minutes
- 01 Dec 2017 Meeting Minutes
- 11 Dec 2017 Meeting Minutes
- 19 Jan 2018 Meeting Minutes
- 16 Feb 2018 Meeting Minutes
- 02 Mar 2018 Meeting Minutes