Clinical Trials Procedures

The “Sponsor” of the study is responsible for registering the trial in a public registry such as ClinicalTrials.gov. The Sponsor of industry-initiated and funded multi-center studies is the pharmaceutical or medical device company whose protocol you are following. For investigator- initiated studies from our faculty, Georgia Tech is considered the Sponsor and the Institute is therefore responsible for registering those studies. The Institute is a registered Sponsor at ClinicalTrials.gov. Scott Katz from ORIA’s Regulatory Affairs, is the designated administrator for the Institute’s ClinicalTrials.gov account.

The process for registering individual studies is described below. Remember, this pertains only to investigator-initiated studies.

1. First, you must submit to the IRB for review. This must be done prior to registering the trial, although IRB approval will not be provided until the ClinicalTrials.gov NCT number has been received.
   1. Georgia Tech’s IRB does not review the data registered for a given trial. This review is performed by the Institute administrators for Georgia Tech’s ClinicalTrials.gov account. However, ultimate responsibility for record accuracy lies with the Principal Investigator (PI) providing the requested details within Clinical Trails section of the IRB application.
2. The Institute administrators will then request that you complete the following document (ClinicalTrials.gov Initial Questions Document), so that the information can be entered into clinicaltrials.gov. Depending on your type of trial, the administrators will then ask that you complete another document regarding your type of research (ClinicalTrials.gov Interventional Questions Document or ClinicaTrials.gov Observational Questions Document) so they can enter the information that you have provided into clinicaltrials.gov.  The administrators will then let you know if any more information is needed. All of the information in these documents are taken directly from the ClinicalTrials.gov website.
3. After the requested information has been entered into clinicaltrials.gov, the PI will then need to review the information on clinicaltrials.gov to ensure it is accurate and complete. To do this, an individual user account will be established at ClinicalTrials.gov by the Institute administrators for the Principal Investigator (PI) of the study and designees requiring record access. The user account will be created within ClinicalTrials.gov and within a very few minutes of the user account set-up, the PI will receive an e-mail from ClinicalTrials.gov providing the login details and temporary password.
4. Once the information is reviewed and approved by the PI, the Institute administrators will release the submission for review.
5. After the submission has been released by the Institute administrators, ClinicalTrials.gov will perform a system validation and quality assurance review. For protocol records this usually occurs within 2 to 5 days of release. After completion of their review, ClinicalTrials.gov will assign an NCT number and make the record (or updates) publicly available for viewing. Until this occurs, no one outside of Georgia Tech can see the record or updated information. A study is not considered to be registered until the QA process has been completed and the NCT number has been assigned. Please allow adequate time for this process. In order to qualify for publication consideration, enrollment shall not begin until this entire process has been completed.

The Principal Investigator is responsible for maintaining the accuracy of the information on the registered trial. This includes updating the information as appropriate, minimally every 6 months or whenever a significant change occurs, and noting when enrollment ceases. This information should be provided directly to the Institute administrators. Furthermore, the Institute administrators will also periodically check with the study teams for updates on the status of their trials.

The FDA, NIH and OHRP require consent forms that were used in the research to be posted within 60 days after the last study visit by the last participant.  

For clinical trials defined by the NIH or under FDAAA 801, the consent form must be posted in the clinicaltrials.gov system under your registration. In order to comply with this regulation, the PI of the clinical trial is required to inform the Regulatory Affairs staff that enrollment is closed within 60 days of the last participant's last study visit.  Once notified, the Regulatory Affairs staff will upload the consent form that is listed in the IRB submission system to clinicaltrials.gov.

For clinical trials defined by OHRP (45 CFR 46) and do not meet the definition of a clinical trial by the NIH or under FDAAA 801, the awardee must post a consent form that was used in the study to one of two federal websites within 60 days after the last participant's study visit. The Regulatory Affairs Staff will be responsible for posting the consent form to the federal website.  Therefore, in order to comply with this requirement, study teams who are conducting clinical trials as defined by 45 CFR 46 must inform the Regulatory Affairs staff that the enrollment is closed within 60 days of the last participant's last study visit.  Once notified, the Regulatory Affairs staff will upload the consent form that is listed in the IRB submission system to one of the designated federal websites.

The Principal Investigator is responsible for entering in the clinical trial results for the registered trial. The results include sections such as Participant Flow, Baseline Characteristics, Outcome Measures and Statistical Analysis, Adverse Events, and the Protocol and Statistical Analysis Plan. This information should be entered by the Principal Investigator. Clinicaltrials.gov has several help documents to aid investigators in this process.

Once the results have been entered and the documents uploaded, please notify the Regulatory Affairs staff, as this should be released to the PRS system by the Institute administrators. Please note that the Institute administrators may periodically check with the study teams for updates on this process.

Please be aware that results are required to be posted 1 year after the study completion date.  Please also note that the PRS review process for results can take several months to be completed.  Additionally, the review time does not push back the due date.  Therefore, please provide ample time to complete this process as your results posting may require additional submissions and reviews.

Please do not hesitate to contact the Regulatory Affairs and Clinical Trials Office should you have any questions about these important requirements.