Selected Auditing Services

Lucid routinely performs audits of clinical databases.  In consultation with the client, the level of inspection is determined.  For some studies, every subject is included in the audit.  For most, an agreed upon level is randomly chosen and those subjects are then included in the audit.

The audit is only performed on locked databases, and the initial step is to obtain all of the information in each of the fields for each subject included in the audit.

The auditor then compares the electronic entry in the database to the entry contained in the original case report form.  Any discrepancies are delivered verbally when they are found.  They are later communicated in the Draft Audit Report.

Once all of the entries for the selected subjects have been verified, the auditors work with the data management staff to get any needed corrections made to the database.

Once the database has been corrected, a final check is made to the locked database and a Final Audit Report is issued.

●  The selected project had over 600 subjects. 

●  This study was critical to the company’s success, so they chose to audit 100% of the subjects (other studies for this client were usually sampled according to Mil Standard 105E, inspection level 2).

●  Since this was a periodontal study, each subject had 192 pocket results at each examination. 

●  Over 250,000 individual fields were verified by our auditors for this study.

●  In addition to the pocket scores, more traditional fields were included in the audit, such as medical biographies, medical history, clinical visit details, adverse events and concomitant medications.

●  Due to the large number of data points to verify, noted discrepancies were provided to the client daily.  This allowed the client to investigate all problems and have the solutions in place at the conclusion of the first audit round, ultimately leading to a timely closure on the project.