The UCLA CTSI provides researchers and members of the public with free and easy access to information on clinical trials being conducted in the LA area. These trials have all been registered with the NIH Clinical Trials Registry and offer a synopsis of UCLA CTSI's current initiatives.
It is encouraged that researchers register their trial with ClinicalTrials.gov's Protocol Registration System (PRS). It's not only a necessary step in the research process, but also the best way to attract study participants and publication opportunities. Below is an overview of the registration process.
In order to register a trial, you must have a Protocol Registration System (PRS) account. These can be obtained by either an organization or an individual investigator. Organizations are able to register several users allowing for multiple trials to be registered easily. To prevent duplicate registration, take care to have a registration system in place. In instances where there are multiple sites or several sponsors involved, the lead sponsor should be responsible for registering the trial.
As mandated by the Food and Drug Administration Amendments Act of 2007, Section 801, “applicable clinical trials” must be registered and publically report results. Applicable clinical trials are commonly defined as those that are interventional studies (studies consisting of one or more research arms) and those that are trialing devices, drugs or biological products that would require FDA approval.
Trials may be registered before obtaining IRB approval, but they cannot begin recruiting until they have received approval from their institution's IRB. At that time, principal investigators should update study status from $ldquo;not yet recruiting” to “recruiting” and make any necessary updates to the protocol.
Results must be reported for all registered trials. To do this, results can be submitted manually, or synched with ClinicalTrials.gov's XML structure through an organizational account. Results must be reported within one year of the final data collection.
For more information on reporting results, read “Reporting ‘Basic Results’ in ClinicalTrials.gov,” published by CHEST Journal.
For more information on registering a clinical trials and reporting trial results, visit ClinicalTrials.gov.