ABOUT OUR SOURCE DOCUMENTS
We know that when it comes to clinical trials nothing matters more than proper documentation, this alone is the most critical element of any successful study. Every aspect of the study must be properly documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Source documents are original documents created during a clinical trial, in which study data are obtained. Our purpose is to create quality source documents that are friendly to be completed and reliable.
WHAT IS THE PURPOSE OF SOURCE DOCUMENTATION?
The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required.
It is the tool which confirms the eligibility criteria of the subject in the given trial.
COMPLIANCE WITH GCP,
HIPAA AND OTHER
THE PURPOSE OF SOURCE DOCUMENTS:
Collecting and transferring data to CRFs which carry over to the study database.
Instruct study coordinators and other site personnel on what data to collect and how to collect them.
Providing an auditable link in the chain from the study database back to the original source.
Demonstrating that the data was collected in compliance with Good Clinical Practice (GCP) and other regulations, including being “ALCOA”: Attributable, Legible, Contemporaneous, Original and Accurate.
Provide information necessary to answer data queries.
WHY PROPER DOCUMENTATION MATTERS
One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation.
Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation’ is cited in 6 out of the 10 warning letters issued by US-FDA to clinical investigators in 2010.
Multiple records for same data points making it unable to determine which served as the accurate source record