How to Use this Document The MTS:PTC document does not address every potential term selection situation. Medical judgment and common sense should also be applied. This document is not a substitute for MedDRA training. It is essential for users to have knowledge of and content. For optimal MedDRA term selection, one MedDRA’s structure should also refer to the MedDRA Introductory Guide (see Appendix, Section 4.2). Users are invited to contact the with any questions or comments about this MTS:PTC document. Preferred Option In some cases, where there is more than one option for selecting terms, a “preferred is identified in this document. Designation of a does not option” “preferred option” limit MedDRA users to applying that option. Users should always first consider regional regulatory requirements. An organisation should be consistent in the option that they choose to use and document that option in internal coding guidelines. MedDRA Browsing Tools The MSSO and JMO provide two browsers (a Desktop browser and a Web-Based browser) that allow for searching and viewing the terminology (see Appendix, Section 4.2). Users may find these browsers useful aids in term selection. GENERAL TERM SELECTION PRINCIPLES Quality of Source Data The quality of the original reported information directly impacts the quality of data output. Clarification should be obtained for data that are ambiguous, confusing, or unintelligible. If clarification cannot be obtained, refer to Section 3.4. Quality Assurance To promote consistency, organisations should document their term selection methods and quality assurance procedures in coding guidelines consistent with this MTS:PTC document. Clear initial data can be promoted through careful design of data collection forms, and training of individuals in data collection and follow-up (e.g., investigators, drug sales representatives). Term selection should be reviewed by a qualified individual, i.e., a person with medical background or training who has also received MedDRA training.
How to Use this Document The MTS:PTC document does not address every potential term selection situation. Medical judgment and common sense should also be applied. This document is not a substitute for MedDRA training. It is essential for users to have knowledge of MedDRA’s structure and content. For optimal MedDRA term selection, one should also refer to the MedDRA Introductory Guide (see Appendix, Section 4.2). Users are invited to contact the with any questions or comments about this MTS:PTC document. Preferred Option In some cases, where there is more than one option for selecting terms, a “preferred option” is identified in this document. Designation of a “preferred option” does not limit MedDRA users to applying that option. Users should always first consider regional regulatory requirements. An organisation should be consistent in the option that they choose to use and document that option in internal coding guidelines. MedDRA Browsing Tools The MSSO and JMO provide two browsers (a Desktop browser and a Web-Based browser) that allow for searching and viewing the terminology (see Appendix, Section 4.2). Users may find these browsers useful aids in term selection. GENERAL TERM SELECTION PRINCIPLES Quality of Source Data The quality of the original reported information directly impacts the quality of data output. Clarification should be obtained for data that are ambiguous, confusing, or unintelligible. If clarification cannot be obtained, refer to Section 3.4. Quality Assurance To promote consistency, organisations should document their term selection methods and quality assurance procedures in coding guidelines consistent with this MTS:PTC document. Clear initial data can be promoted through careful design of data collection forms, and training of individuals in data collection and follow-up (e.g., investigators, drug sales representatives). Term selection should be reviewed by a qualified individual, i.e., a person with medical background or training who has also received MedDRA training.
000240_termselptc_r4_16_sep2018.docx