Building Block Forms – DEVELOPMENT PRACTICES

IRDiRC - Building Block Forms – DEVELOPMENT PRACTICES

Legend:
E = Europe
I = International
J = Japan
U = USA

ODDG_TF_Building-Block-Form_I402_Extrapolation of efficacy and safety in medicine development (Extrapolation)Download
ODDG_TF_Building-Block-Form_I407_Data miningDownload
ODDG_TF_Building-Block-Form_I412_Decentralized trials Download
ODDG_TF_Building-Block-Form_I413_Use of Biomarkers in Orphan Drug DevelopmentDownload
ODDG_TF_Building-Block-Form_I414_Patient surveys / Patient Preferences studies / Ethnographic researchDownload
ODDG_TF_Building-Block-Form_I415_Development and use of Patient-Centered Outcome Measures (PCOM)Download
ODDG_TF_Building-Block-Form_I416_Compagnion diagnostics (Comp Diag)Download
ODDG_TF_Building-Block-Form_I417_Development of product specific bio-analytical assays Download
ODDG_TF_Building-Block-Form_I418_Natural History Studies (NHS)Download
ODDG_TF_Building-Block-Form_I419_Registries for Rare DiseasesDownload
ODDG_TF_Building-Block-Form_I421_Alternative designs for Small Population Clinical Trials (AD-SPCT)Download
ODDG_TF_Building-Block-Form_I422_Feasibility-Patient engagement in trial design and feasibility (F-P trial D&F)Download
ODDG_TF_Building-Block-Form_I423_Feasibility-Patient engagement in trial endpoint selection (F-P ES)Download
ODDG_TF_Building-Block-Form_I424_Ethic’s Committees assessment of protocols for trials with orphan medicationsDownload
ODDG_TF_Building-Block-Form_I425_FAIR principle for data useDownload
ODDG_TF_Building-Block-Form_I431_Target Patient Value ProfileDownload
ODDG_TF_Building-Block-Form_I432_Horizon Scanning: Landscape analysis/ Stakeholder identification and engagement Download