ThefirstpointofcontactforCBERregardingelectronic.docVIP

The first point of contact for CBER regarding electronic submission of data is the review office for questions about content or structure. Technical questions regarding SDTM, ADaM and CDASH submission can be addressed to CBER.CDISC@ This Study Data Standardization Plan (checklist) should be used by Sponsor/Applicant to create the plan for submission of electronic data in SDTM, ADaM and CDASH to CBER. This checklist can be included in any meeting packet (e.g. pre-IND and pre-BLA) sent to CBER. At the meeting any changes to the checklist are to be discussed and documented. The Study Data Standardization Plan (checklist) can be used in pre-IND meeting, end of phase I meeting, end of phase II meeting, prior to pivotal study meeting and pre-BLA meeting. The items in the checklist that do not fit the sponsor’s study status can be left blank. CBER encourages the use of CDASH standards (domains and CRF*) to collect the clinical trial datasets as early as the pre-IND stage. If the study datasets have not been collected in CDASH formats, then CBER encourages the conversion into SDTM and ADaM standard formats before final submission. The Study Data Standardization Plan (checklist) should be revised as necessary during the clinical trial and data collection. For example, the checklist for pre-IND can be modified correspondingly in pre-BLA submission. If sponsor used different domains in each phase of study, then sponsor should develop a separate new sheet for SDTM and ADaM DATASETS for each study. Customized domains need to be explained to reviewers. Why do you think that specific datasets could not be put into an existing domain? CBER encourages the sponsor use define.xml format or live links for the Study Data Standardization Plan (checklist). A legacy data folder will be required if SDTM datasets were converted from legacy data in the final submission but will not be included in this checklist. The checklist is only for SDTM, ADaM, CDASH and CDISC compliant datasets.