SDRG and ADRG

During the review process by the FDA, it is essential to be able to establish traceability between the data collection stage and the analysis. If the FDA reviewer is unable to trace the data then the regulatory review of a submission may be compromised. The traceability can be improved by using the CDISC standards. In the event that the submitted files contains special cases, the SDRG and the ADRG will be the main documents that the FDA reviewer will refer to.

According to the FDA Study Data Technical Conformance Guide, the SDRG should describe any special considerations or directions that may facilitate an FDA reviewer’s use of the submitted data and may help the reviewer understand the relationships between the study report and the data. The SDRG also establishes the traceability of the SDTM datasets and the raw data. Traceability is very important for the review from the FDA.

The SDRG should describe any special considerations or directions that may facilitate an FDA review. It may help the reviewer to understand the relationships between the study report and the data. In the case of none CDISC data converted to CDISC standard traceability is often the main issue.

Here is an example of special consideration that has to be taken into account in the SDRG:

Some fields in the CRF are potentially not tabulated in the SDTM datasets. These fields are annotated as “Not Submitted” in the CRF. All fields that are annotated as “Not Submitted” have to meet the following criteria :

1) Only used to trigger an event or record reported for a subject.

2) Not needed for SDTM or Analysis.

3) Not available in raw data, for site use only.

4) Redundancy. The information was already captured by other variables.

5) Not mapped to SDTM because there were no results.

6) To facilitate certain operational processes including data cleaning and dynamically creating additional forms in the electronic data capture system.

7) Only used to differentiate admission & discharge elements, for deriving start date & end date.

In that case there should be an explanation in the SDRG stating why the data have not been submitted.

The SDRG must be written according to a certain structure. PHUSE provides template in order to formulate the reviewers guide. The different sections of the reviewers guide are as follows:

• Introduction

. Purpose

. Acronyms

. Study Data Standards code lists and Dictionary Inventory

• Protocol Description

. Protocol Number and Title

. Protocol Design

. Trial Design Datasets

In conclusion:

The SDRG should describe any special considerations in the tabulated datasets. The purpose of this document is to facilitate the review of data submitted to the FDA.

The ADRG is a separate document. It provides FDA reviewers with context for analysis datasets. The ADRG also provides a summary of ADaM conformance findings. The ADRG also duplicates information found in other submission documentation such as the protocol, statistical analysis plan (SAP), clinical study report, define.xml…