Difference between revisions of "Subject Data Story Boards"
| Line 1: | Line 1: | ||
== Links == | == Links == | ||
| − | [[Stage IB Project Page|Stage IB Project page]] | + | [[Stage IB Project Page|Stage IB Project page]] | [[Study Design, Study Participation and Subject Data|CDISC HL7 Project Page]] | [[Stage 2 Project Page|Stage 2 Page]] |
== Class 1 – Sponsor Planned Data == | == Class 1 – Sponsor Planned Data == | ||
| Line 10: | Line 10: | ||
=== 3. === | === 3. === | ||
Planned data being captured but study is high risk and therefore FDA requested that data be provided at regular intervals while the trial is running | Planned data being captured but study is high risk and therefore FDA requested that data be provided at regular intervals while the trial is running | ||
| + | == Class 2 == | ||
| + | Data collected in connection with ICSRs. It should be easy to make connections between data in the ICSR and other data conveyed in the Subject Data message. At minimum, this probably means that the Subject Data message needs to include unique identifiers for ICSRs. | ||
| + | === 4. === | ||
| + | An SAE occurs and is reported in an ICSR. At the time the study report is submitted and the SubjectData is used the SubjectData message should refer to the ICSR content and not repeat the data. | ||
Revision as of 18:44, 31 October 2008
Links
Stage IB Project page | CDISC HL7 Project Page | Stage 2 Page
Class 1 – Sponsor Planned Data
Data collected in accordance with the plan. The Study Design message conveys (among other things) the plan for data collection, the Study Participation message includes information on the subjects in the study, and thus those two messages imply an expected set of data to be collected. The subject data message needs to be able to convey that data.
1.
Study A1234 is complete and Acme Pharmaceuticals now wants to send to the FDA all the observations recorded for each subject during the study as part of their study report submission. Acme uses the CDISC-HL7 subject data message to provide all the recorded observations, as well as all the derived parameters resulting from those observations, as defined by the CDISC SDTM and ADaM standards. The message contains all important relationships, such as the relationship between an observed and planned assessment (or lack thereof), and the relationship between unplanned assessments and other observations (i.e. physical exam finding of jaundice led to a bilirubin measurement). Those observations that were previously reported in a spontaneous adverse event report are not re-submitted, but rather updated and referenced.
2.
FDA runs some form of check to assess if all planned activities were performed. This requires access to the plan held within the Study Design message and needs to allow for all paths to be evaluated at a high level of detail definition (sufficient to allow for a machine to perform the check)
3.
Planned data being captured but study is high risk and therefore FDA requested that data be provided at regular intervals while the trial is running
Class 2
Data collected in connection with ICSRs. It should be easy to make connections between data in the ICSR and other data conveyed in the Subject Data message. At minimum, this probably means that the Subject Data message needs to include unique identifiers for ICSRs.
4.
An SAE occurs and is reported in an ICSR. At the time the study report is submitted and the SubjectData is used the SubjectData message should refer to the ICSR content and not repeat the data.
