Drug Evaluation Committee Attachments to the 2011-17 Common Line List for Individual Reporting
Related classification: clinical trial contracting procedures
First published: Aug 2011
Question
There is a column for "Materiality" in "Form 2 (i)" attached to the "Common Line List for Individual Reporting" provided by the sponsor.
In the material from one sponsor, it used to be mostly "3 (Important/Serious)," but since the July 2010 safety information, it is all "4 (Non-Serious/Serious)," so we checked it and found that since the information is not currently collected, the information was not entered when it was created and "4 (Non-Serious/Serious)" was automatically entered. The response was that since the information is not currently collected, the information was not entered when the form was created and "4 (Non-Critical/Serious)" was automatically entered. Interpreting this as it is, I think this "Severity" field is meaningless.
Also, please tell us if there are certain mandatory items to be provided by the sponsor to the site among the items in "Form 1" and "Form 2 (i)" attached to the "Common Line List for Individual Reporting".
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
I would like to express my opinion based on the assumption that the "Form 1" and "Form 2 (i)" in your question are the "Adverse Reaction/Infectious Case Report for Investigational Drugs" and "Adverse Reaction/Infectious Case Form for Investigational Drugs" submitted by the sponsor to the Ministry of Health, Labour and Welfare (actually, the Pharmaceuticals and Medical Devices Agency).
First, as for the descriptions of "Important" and "Non-Important," according to the "Q&A on 'Data Items and Message Specifications for Transmission of Individual Case Safety Report' (Part 4) (April 13, 2005, Ministry of Health, Labor and Welfare, Drug and Food Safety Division/Safety Measures Division, Office Communication)," the "Adverse Reaction/Infectious Drug Reaction and Infectious Disease Case Form (Form 2 (1))" is the one to be submitted to the NDA. The importance column of the case report (Form 2 (i)) discriminates between the diagnostic name and the accompanying symptoms. For example, fever, chills, etc. are classified as "non-significant" as an accompanying symptom, and influenza-like syndrome is classified as "significant" as a diagnostic name. In this way, when multiple events are described in a single case report, this field is used as appropriate when the reporter deems it particularly necessary to flag the importance of the event. In Europe and the U.S., it is not considered a required field, so there are many cases, especially in overseas cases, where it is not indicated. In Japan as well, the above Q&A (No. 4) states that this is an "optional field," and sponsors do not actively collect information from investigators, etc. on domestic cases. As a result, the response to the columns in "Form 2 (i)" of the report by the authorities has varied. In any case, the Materiality column is not an essential item in the safety evaluation of reported adverse events, and should be viewed as reference information.
In addition, "Form 1" and "Form 2 (i)" provided by the sponsor to the site are copies of those submitted to the MHLW, so there is no requirement that they be provided to the site. As for the safety information to be provided by the sponsor to the implementing medical institution, the Pharmaceutical Manufacturers Association of Japan (PMAJ) proposes that basically only the common line list for individual reports should be provided. Individual case sheets are considered to be information derived from clinical trials in Japan and overseas and to be provided as necessary, so the content to be provided will differ for each clinical trial. Please refer to Pharmaceutical Research 40(5) 259-272 (2009) for more information on the proposal by the Pharmaceutical Manufacturers Association of Japan (PMAJ).