On 26th March 2021 a team of experts from Industry, CDISC and the FDA came together to discuss the topic of Data Integration and Submission Challenges. The panel actively sourced questions prior to the event from the SDTM/ADaM Implementation FAQ project, as well as a call out to our community members who were given the opportunity to submit questions ahead of the event. In addition, on the day questions came in via the Q&A chat from the audience. Many questions were answered 'live' so we encourage you to listen back to the recording, but those that the panel didn't have time to address have been curated and captured below. The following blog shares highlights and relevant links to be able the listen back option. |
| Questions | Team Response |
| What's FDA preference? Integrating ADaM from individual ADaM seems a good option if ADaM at study level were well "curated". But still would it be a plus for FDA having one single source with data from all studies contributing for example to an ISS? i.e. iSDTM. | From individual ADaM to integrated ADaM is a good option and is recommended. However, there are multiple approaches discussed during the EAtCQ event which the Sponsor can consider. Sponsors should discuss ISS content and approach during the pre BLA or pre NDA meeting with their review division. |
| Are there any initiatives taken to align the data standard requirements (versions) across different regulatory authorities?. | There is no formal initiative to use the same data standards requirements across the different authorities. |
| We have a couple of situations where FDA have asked us to provide integrated SDTM - do different divisions have different expectations?. | It's not uncommon for different divisions to have different expectations when it comes to how the standard data is integrated. The language is continually updated in the Study Technical Conformance Guide to further establish a consistent request and requirements across the divisions. This will evolve based on industry approaches and existing code, and each individual divisions have adopted and grown accustomed to over time. |
| What is the input from FDA representatives on submitting ADaM programs only or submit both (ADaM & TFL's programs)?. | We require from SDTM to ADaM and then other requests will be based on division. |
| What is the strategy to be followed for submitting aCRF for ISS studies?. | There is no expectation to have an aCRF for ISS. The data is collected for the individual study and so the aCRF at the study level is what is expected. |
| What about an oncology compound that continues to submit for each unique indication/tumour type. We re-use the same studies in our ISS again and again. | The approach of adding newer studies to the existing ISS is valid. |
| For integrated SDTM and ADaM datasets used for ISS/ISE, is there a need to run the SDTM/ADaM conformance validation checks on the datasets, in the same way we do at study level?. | Yes. Even though conformance or validation rules does not exist from CDISC and FDA for integrated data, it is necessary to ensure the data/metadata is compliance just like individual study. Of course, some of the validation checks may not apply for integrated data. The upcoming iADRG and iCSDRG template do have provision to provide conformance issue summary just like ADRG and cSDRG template. |