Revision of the ICH guideline on clinical safety data management: data elements for transmission of individual case safety reports

Original publisher: [Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005] OCLC Number: (OCoLC)402677963 Subject: Clinical pharmacology. Excerpt: ... E2B ( R ) Electronic Transmission of Individual Case Safety Reports 656 User Guidance: 657 MedDRA LLT code should be used in the main descriptive column for disease / surgical procedure / etc. 658 659 660 B. 1.10.7.2 Text for relevant medical history and concurrent conditions of 661 parent ( not including reaction / event ) B. 1.10.8 Relevant past drug history of parent ( repeat as necessary ) 662 Name of drug MedID PhPID Start date End date Indication Reactions ( if any and as reported known ) 663 664 User Guidance: 665 666 To standardise this information, the ICH M5 guideline should be used. Based on the medicinal product name as reported by the primary source, the most specific identifier, being either the Medicinal Product Identifier ( MedID ) or the Pharmaceutical Product 667 Identifier ( PhPID ) should be provided. If a MedID and a PhPID for the reported medicinal product are not available, this field 668 should be left blank. MedDRA LLT code should be used in the Indication and Reaction columns. 669 670 671 672 B. 2 Reaction ( s ) / event ( s ) 673 User Guidance: 674 The designation of " i " in this section indicates that each item is repeatable and that it corresponds to the same " i " in all 675 676 subsections. A separate block ( i ) should be used for each reaction / event term. For example, if two reactions are observed, the first reaction would be described in items B. 2.1.0 through B. 2.1.6, and the other reaction would be described in items B. 2.2.0 through 677 678 B. 2.2.6. 679 680 B. 2. i. 0 Reaction / event as reported by the primary source 681 User Guidance: 682 683 The original reporter's words and / or short phrases used to describe the reaction / event should be provided. These can also be included in the narrative B. 5.1. 684 685 B. 2....