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ICH E6 R3 mmch gcp gclp workshop 2025.pptx
- 1. ICH E6 (R3)and its impact Dr Balaram Ghosh MBBS DGO MD PhD DM ACME Dept of Pharmacology, MMC
- 37. New Terms RemovedTerms Assent Coordinating Committee Data Acquisition Tool (DAT) Documentation Data Integrity Investigator/Institution Metadata Opinion (in relation to IRBs/IECs) Monitoring Plan Original Medical Record Reference Safety Information (RSI) Standard Operating Procedures Service Provider Well-being (of the trial subjects) Signature
- 38. Original Term inICH E6 (R2) Amended Term in ICH E6 (R3) Contract Agreement Unexpected Adverse Drug Reaction Suspected Unexpected Serious Adverse Reaction (SUSAR) Validation of Computerised Systems Computerised Systems Validation Essential Documents Essential Records Trial Site Investigator Site Source Data/Source Documents Source Records Subject/Trial Subject Trial Participant Subject Identification Code Trial Participant Identification Code Vulnerable Subjects Vulnerable Participants
Editor's Notes
- #1 ICH" most commonly refers to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It's a global initiative that aims to standardize and harmonize technical requirements for the development and registration of pharmaceutical products across different countries. This harmonization streamlines the drug development process, making it more efficient and cost-effective.
- #2 ICH" most commonly refers to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It's a global initiative that aims to standardize and harmonize technical requirements for the development and registration of pharmaceutical products across different countries. This harmonization streamlines the drug development process, making it more efficient and cost-effective.