Guidance Breakdown: FDA's BIMO Electronic Submission Requirements

The FDA just released its final guidance finalizing draft requirements from 2018 into binding requirements for electronic submission of clinical study data used in BIMO inspections.

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The FDA has finalized its guidance for standardizing the electronic submission of bioresearch monitoring (BIMO) inspection data for NDAs and BLAs regulated by CDER.

This guidance, which finalizes the February 2018 draft, establishes binding requirements for how companies must submit clinical study data used for inspection planning and execution. The requirements become mandatory 24 months after the guidance's issuance.

Here’s our breakdown.

Scope and applicability

The guidance applies to electronic submissions containing data from all major (pivotal) studies supporting safety and efficacy claims in:

• New Drug Applications (NDAs)

• Biologics License Applications (BLAs) regulated by CDER

• Supplements containing new clinical study reports

• Certain IND submissions made in advance of planned NDA/BLA submissions

The requirements specifically target data the FDA uses to plan and conduct BIMO inspections to make sure field investigators have the necessary information and can identify inspection sites efficiently.

Key requirements and implementation details

The guidance establishes specific requirements for three interconnected categories of submission content, each serving distinct purposes in the FDA's inspection planning and execution process.

Let’s walk through them one by one.

1. Clinical study-level information

The clinical study-level information is the foundational documentation for inspection planning and consists of three critical components:

• Site Participation Documentation: Companies must generate comprehensive tables documenting all clinical sites involved in the study conduct. These tables must capture the clinical investigator's name for each site location, accompanied by a unique site identification number for clear tracking and reference. Physical location details must include complete street address, city, state, and country information. Contact details must encompass phone numbers, fax numbers (when available), and email addresses (when available). This information is for inspection scheduling and coordination.

• Contracted Entity Documentation: A thorough accounting of all contracted study-related activities must be maintained and submitted. This documentation should detail all entities contracted by the sponsor for any study-related activities, regardless of whether regulatory obligations were transferred. For each contracted entity, companies must explicitly specify which study-related activities were contracted and clearly indicate whether the sponsor transferred responsibility for the regulatory obligations associated with those activities. This includes activities such as site monitoring, randomization management, and drug distribution.

• Protocol Documentation Package: The submission must include a complete protocol documentation package containing:

  • The full study protocol

  • All protocol amendments

  • Annotated case report forms for each pivotal study supporting safety and efficacy claims

2. Clinical study-level information

The subject-level data line listings are the primary verification tool during inspections and must adhere to specific organizational requirements.

These listings must be organized by clinical site and must present both primary (raw) data points and any derived data used in the study. A critical distinction is made between primary data points and derived data — both must be included to enable verification of calculations and conclusions.