How are essential documents maintained in clinical research?

In the field of clinical research, the maintenance of essential documents is crucial for ensuring the integrity, quality, and accuracy of clinical trial data. Essential documents refer to those records that allow the evaluation of the trial's conduct, compliance with applicable regulations, and evidence of the rights, safety, and well-being of participants. These documents are maintained through meticulous record-keeping practices. Initially, they are created and collected by various stakeholders such as investigators, sponsors, and regulatory authorities. To ensure their integrity and traceability, essential documents are typically stored and organized in a secure and easily accessible manner, either in paper or electronic format, depending on the policies and requirements of the organization or regulatory agency. Regular review, maintenance, and archiving of these documents throughout the trial's lifecycle are essential to facilitate transparency, regulatory inspections, and data accuracy.

This mind map was published on 16 January 2024 and has been viewed 109 times.