Clinicaltrials.gov typically requires manual data entry for submitting protocol and basic results clinical trial details. By implementing a software solution, the manual data entry process can be automated to provide for automatic submission of clinical trial results to clinicaltrials.gov. Several key question for automating the submission process are included below. Determining the best software solution for automatic clinicaltrials.gov database uploads and database import largely depends on your current data collection process.
Are you hoping to automate the submission of protocols or basic results?
Data entry submissions to clinicaltrials.gov depends on two major sections of clinical study data: protocol details and basic results. Organizations may be more comfortable with manual entry of the protocol information, which sets up a clinical trial study and provides the initial details and plan. However, the data entry of basic results can become an ongoing and repetitive task. This is especially the case with entering adverse event and serious adverse event data, which are one of the larger clinicaltrials.gov import targets for automated submission and database upload.
Are you using an existing clinical trial management software or database?
Depending on your current clinical trial data recording process and implementation, a software solution could differ in how data is exported from an existing database or software system, converted to the required clinicaltrials.gov upload and import format, and then automatically submitted to the clinicaltrials.gov system for processing.
How is your data currently stored?
Most clinical research organizations handle clinical study data electronically and thus, have existing databases housing clinical trial data. Exporting this data and converting to the required clinicaltrials.gov format can greatly streamline and automate the submission process. Clinical trial data may be exported and saved from existing databases, transformed to a specific dot gov format, and then automatically uploaded to clinicaltrials.gov. Examples of data that may be automated in the submission process include adverse event basic results, serious adverse events, and intervention group / treatment group data related to adverse event results.
Automating submission to clinicaltrials.gov by uploading database records can greatly expedite submissions, saving time, preventing errors, and optimizing the process. Consider a software solution to help automate your clinicaltrials.gov submission process needs.