Introduction

There are occasions where non-GLP studies need to be included in an FDA submission to support a safety decision, and such studies need to be represented in SEND. The agency states this in section 4.1.3.4.1 Scope of SEND for SENDIGs v3.0, v3.1 and v3.1.1 of their Study Data Technical Conformance Guide:

If the nonclinical pharmacology or toxicology study is required to support a regulatory decision by the Agency, such that the absence of this study would result in a determination that there is insufficient information to assess the risks to human subjects, then the nonclinical study would require SEND.

Later in this section, this is then clarified specifically in relation to non-GLP studies:

The requirement for SEND is not limited to GLP studies. As both GLP and non-GLP toxicity studies may be submitted to the FDA to support clinical safety, the decision for inclusion of SEND is independent of GLP status. In cases where non-GLP toxicity studies are submitted to support a determination of safety, as outlined above, such studies must include SEND.

When such data are collected in Climb, the data can then be represented in a SEND submission package using Instem’s tools and services. Our SEND conversion and management software, Submit™, can take the output from Climb and render it as SEND datasets. Instem also provide services, call SEND Advantage™, where our team use the Submit software to generate a submission-read SEND package for our customers.

Data Conversion

In order to represent the data collected in Climb, as submission-Ready SEND, the collected data need to be exported from Climb in Excel format. This includes any data that would fall under the following domains:

Submit includes the Flat File Data Adapter function which can read the Excel exported from Climb for any of the above domains and produce the appropriate SEND datasets. As Climb is so flexible, and each study is individual, it is likely that a new set of these Flat File Data Adapters will need to be configured for each study.

In addition to this, details about the study plan are also required. Of these details, many can be collected in Climb such as:

• List of all study subjects, including start and end dates and planned dose group
• Planned Dosing Duration
• Route of Administration
• Species

Some such required parameters can be derived from data held in Climb, such as:

• Age of the subjects at the start of the study
• Start Date/Time of Dose Interval
• End Date/Time of Dose Interval

However, there are other parameters that are required for SEND, that are not currently included in Climb and the information would need to be provided from another source. Examples of these parameters are:

• Treatment Vehicle
• Recovery Period
• Study Design
• Study Report Status
• Study Category

It’s not that these data aren’t present in Climb necessarily, rather the data simply does not map well out of the box.

Please note that for the study plan detail lists shown above, these are not exhaustive lists, and are just some examples. A full list of parameters, and their relation to Climb can be provided by Instem, if required.         

Recommendation

For any organisation that would need to convert a reasonable number of studies to SEND each year and has in-house SEND expertise, we would recommend purchasing the Submit software suite for data conversion, and we can provide additional training and support specifically tailored toward handling Climb data.

For any organization that only has occasional studies that require SEND and / or have little in-house SEND expertise, we would recommend using our SEND Advantage services to prepare the submission-Ready SEND package. In this case, the data listed in the Data Conversion section of this document would need to be supplied to our team.