Investigator Site File

What is an Investigator Site File (ISF)?

ISF plays a critical role in a study’s success. The investigator site file consists of trial documents from the initiation to closeout. Maintaining the site file is the responsibility of principal investigators. Principal investigators are doctors or any medical practitioner for a particular disease or indication. Principal Investigators have many responsibilities. They conduct clinical trials under investigation. They verify informed consent and protect the rights and welfare of the patients according to applicable regulations. Importantly, investigators are responsible for preserving all data relating to a study before, during, and after the clinical trials. If documentation and filing are not followed as per ICH GCP and GDP (good documentation practice), it can lead to 483, FDA warning letters, disqualifications or restrictions, and, in extreme cases, even criminal prosecutions. This is why an Investigator site file is critical – but can also be so daunting (CRC knows!!!!). For easy understanding, we are dividing clinical trials into the phases – Before the clinical trial, During the trial, and after the trial. Before the Clinical Trial Before the trial starts i.e trial initiation, the following documentation must be filed: During the Clinical Trial As the trial progresses for the recruitment, the following documentation should be added to the files : After the Clinical Trial At the end of the trial, the final documentation must be added to the file: Conclusion Handling of documents is a critical role. The designated person and investigator have to understand the criticality of each document. This is, needless to say, a lot to keep track of. There are a lot of versions that happen when the trial continues for the years. Considering the bulk of papers and handling of documents, it is difficult to pace and track everything. In conclusion, the site should focus on an approach for the tracking of documents. Using eSIF is highly recommended.

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