Study Data Standardization Plan – Importance and Advantages

The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for Drug Evaluation and Research)  and CBER (Center for Biological Evaluation and Research)  the expected CDISC (SDTM, ADaM and SEND) standards used for data in  upcoming clinical and pre-clinical trials.

SDSP is used in early stages of the submission process, preferably before initiation of a pre-clinical or clinical trial, for communication between the sponsor and the reviewer (or Project Manager within the FDA) and as a reference for Pre-IND or end of phase 2 meetings. The FDA indicates the plan should be included as part of the submission process and should take place as early as possible but in any case no later than the end of phase 2.

The document is essential since it allows both sides to make sure the standards used will be acceptable once data is submitted, avoid surprises down the road and make sure standardization issues are brought up early in the process. The fact there are various options and versions available for sponsors to use make this plan even more important

The SDSP has special importance when it comes to legacy studies. Legacy studies in theory are exempt from being converted to the CDISC standards however often times sponsors chose to convert them (either partially or fully) given their importance as part of the whole submission as well as the level of dependency the newer, ‘CDISC-based’ studies have on their results. In this case the SDSP is used as the communication platform to make sure the legacy conversion logic the sponsor uses is acceptable by the regulatory authorities.

ISS/ISE (Integrated Summary of Safety and Efficacy) should also be specified in the SDSP and the cross-studies dependencies should be carefully evaluated. For example – which SDTM version should be used for an ISS which is based on one study which uses SDTM 3.1 and another which uses SDTM 3.2?

Writing of the SDSP should be done using thorough planning, considering the use and implications of the various standards, cross-study consistency and dependency and legacy studies strategy, and should be compiled by professionals with in-depth  experience in clinical/non-clinical data as well as with thorough understanding of the CDISC standards.