Which document specifically targets electronic submission efficiency at CDER?

The CDER Common Data Standards Issues Document is specifically designed to address electronic submission efficiencies at the Center for Drug Evaluation and Research (CDER). This document focuses on the common issues encountered in electronic submissions, providing guidance on how to streamline the submission process by adhering to standardized data formats and protocols. By identifying challenges and offering solutions within the realm of data standards, it aids sponsors and submitters in improving their electronic communication with the FDA, leading to more efficient reviews and approvals.

The other options provide important information related to clinical trials and data management but do not specifically aim at the efficiency of electronic submissions. For example, the Study Data Standards outline the framework and guidelines for data collection, while the Adverse Events Form is more about reporting individual safety issues. The Lab Data Form pertains to data collection in the laboratory context but lacks the focus on overarching submission efficiency that the CDER Common Data Standards Issues Document addresses.