ICH M14 took effect in March, and it changes when real-world data source selection has to happen. Feasibility is now an input to study design rather than a step that follows it. Here is what the guidance requires and what to ask data partners during evaluation.
Discovery
Learnings
- auto_storiesStories
- categoryAreas
- helpFAQ
- forumConversations
- descriptionPapers
- mailNewsletters
- video_libraryVideos
- timelineTimeline
Guidance
- codeTechnology of APIs
- business_centerBusiness of APIs
- campaignEvangelism of APIs
- gavelGovernance of APIs
- historyHistory of APIs
- account_balancePolitics of APIs
Toolbox
- domainProviders
- apiAPIs
- cloudSolutions
- buildTools
- verifiedStandards
- gavelRegulations
- horizontal_ruleHeaders
- layersOverlays
- extensionExtensions
- schemaSchema
- policyPolicies
- ruleRules