Abstract 3740: Using Standardized Web-based Tests in Clinical Trials to Improve Investigator and Coordinator Protocol Familiarity: Experience from Antihypertensive Treatment of Acute Cerebral Hemorrhage II trial
Background: Prior to site initiations, the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-II) trial steering committee require that all investigators and coordinators participating in the trial pass a multiple choice web based test that assesses the individual’s knowledge of the trial protocol and manual of procedures. Requiring a test of this nature was expected to increase the probability that key individuals participating in the trial at various clinical sites had acquired protocol familiarity that would enable them to conduct the trial properly. This benefit was weighed against the additional burden imposed on the site initiation process.
Methods: The steering committee developed a bank of 38 multiple choice questions based on the ATACH-II protocol and manual of procedures (MoP). These questions were identified as appropriate for an investigator, a coordinator, or both. The test was programmed by the ATACH-II Data Coordination Unit and hosted on a web page linked to the ATACH-II Clinical Trial Management System (CTMS). Each time a user registers to take the test a random selection of 14 questions appropriate for that user type (investigator or coordinator) is generated. When a user passes the test, the test certification document is automatically created and uploaded into the ATACH-II CTMS.
Results: In the first year of the trial the test has been taken 418 times. Users are required to answer 12 questions correctly in order to pass. Users registered as investigators have taken the test 263 times with a 55.9% pass rate. Users registered as coordinators or other study team members have taken the test 155 times with a 56.1% pass rate. The pass ratio has increased from 49.5% at the end of the first quarter to 56.0% at the end of the last quarter of the first year. The mean score is 10/14 and the median score is 12/14 among all participants taking the test.
Conclusion: Requiring each investigator and coordinator to become certified by passing this test adds substantial burden to the site initiation process. However, the 56% pass rate observed provides evidence that such efforts may be required to promote the necessary familiarity with the protocol and MoP for this trial.
- © 2012 by American Heart Association, Inc.