How do I update the OSIRIS application to include the NCT number?
When there is not an open modification, the PI, primary research coordinator or secondary research coordinator must:
- Login to OSIRIS
- Click the Studies tab located in the mid-section of the page, then click on this study.
- Click Update ClinicalTrials.gov Information under My Activities on the left-hand side of the study workspace.
- Provide the NCT number and update any other fields, as needed.
- Verify that you have entered the correct NCT number by clicking Check ClinicalTrials.gov Info and comparing the information displayed. (The information will not display until the record is made public on the ClinicalTrials.gov website.)
- Click OK at the bottom right of the page to save the changes.
I entered the NCT number into OSIRIS, so why do I not see this information in the OSIRIS application?
The NCT number and associated ClinicalTrials.gov information may not appear in OSIRIS until the record is made public on the ClinicalTrials.gov website and OSIRIS has downloaded the information. This may take two to three days.
What is the specific wording that must be included in the informed consent document?
All studies registered on ClinicalTrials.gov require inclusion of the following statement, verbatim, in informed consent documents:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
How do I contact the PRS ClinicalTrials.gov staff for guidance on inputting study results or responding to comments issued by a PRS reviewer?
The staff at ClincialTrials.gov provides free one-on-one help via conference call to anyone who has a registered trial. You can send them a publication or data set, and they will take you step-by-step through how to set up your database. They will also go through a submission that is incomplete and guide you through the necessary steps to resolve outstanding issues.
To send a message to the Clinicaltrials.gov staff:
- Login to the ClinicalTrials.gov Protocol Registration and Results System (PRS)
- Go to the “Contact ClinicalTrials.gov PRS” link in top right corner of your home page.
- Include the ClinicalTrials.gov ID (NCT number) in the message and request a one-on-one call to discuss your need for help.
- They will reply to the e-mail listed on your home page.
Are the costs (including staff time) of registration and results reporting (including summary adverse event information) in ClinicalTrials.gov allowable charges on an NIH grant?
Given the nature of this requirement and that the project staff will generally be in the best position to submit and maintain these data, the costs of FDAAA compliance will generally be allowable as direct charges to NIH supported grants. While it is expected that these costs will be covered by the funds provided with the grant, administrative supplements could also be considered. Please refer to the NIH for more information.
How much time does it take to enter data?
Entering data into ClinicalTrials.gov may take considerable time depending on the number of outcomes, study size and adverse events. It is important to ensure that the study outcomes, descriptions and time frames are entered correctly when the record is created. It is recommended that preparation and analysis of the results data be completed by 10 months after the primary completion date, thus allowing adequate time for entry into the ClinicalTrials.gov record and resolution of any comments from the PRS QA staff.
How can I learn more about ClinicalTrials.gov?
Both the ClinicalTrials.gov public website and the PRS website have a wealth of resources for education and guidance, which we encourage you to explore and consult.
Is registration required by UPMC for billing purposes?
UPMC billing requires an NCT number when any study procedure is billed to insurance. This is based on the Center for Medicare and Medicaid Services (CMS) Change Request 8401.