ClinicalTrials.gov. How to Register Your Trial. Adapted from the work of the Clinical and Translational Science Awards (CTSA) program’s Clinical Trials Registration Workgroup of the Regulatory Knowledge Key Function Committee. 2013. ClinicalTrials.gov.
How to Register Your Trial
Adapted from the work of the Clinical and Translational Science Awards (CTSA) program’s Clinical Trials Registration Workgroup of the Regulatory Knowledge Key Function Committee
Database operated by the National Library of Medicine (NLM)
What you’ll find at ClinicalTrials.gov:
Results (including Adverse Events)
*This presentation focuses solely on registration.*
Log in: https://register.clinicaltrials.gov/
Organization Name = Your Institution
The Responsible Party (RP) is responsible for registering their study record on ClinicalTrials.gov, ensuring accuracy, and making sure that the content is up to date. The RP is the only one that can “approve” and “release” the record to ClinicalTrials.gov.
Record Owner (RO) can be anyone with an account; the record is stored in RO’s account.
If the RP is the Principle Investigator (PI), it may be easiest if the PI is also the RO.
The RO can use the “access list” to grant additional users access to the specific record for editing purposes (e.g. if the PI is the RO, he/she can provide access to the study coordinator by selecting the study coordinator from the access list.)
ICMJE: Anyone can register, but generally it’s the PI.
FDAAA: The Responsible Party (RP) defined asIND / IDE holder
If no IND/IDE:
After log in:
Blue Menu box is what everyone sees.
(PRS Administrators see both blue and yellow menu boxes)
Check out the “Help” section
To create a new protocol record, click “Create”
* = Required fields
Click on any underlined words in the left column for the official definition and number of characters allowed for this field.
FDAAA = this information is required to comply with US Public Law 110-85, Section 801 – FDAAA
(FDAAA) = this information may be required to comply with FDAAA.
Enter IRB information here
See the list of oversight authorities for a comprehensive list of all such organizations world-wide. E.g. IRB, FDA etc.
Each institution may handle names and titles of the responsible party differently. Make sure you understand your institution’s policies.
Note: the investigator must be registered with ClinicalTrials.gov to appear on the list.
The list is organized by the first letter of the username, for example, Thomas Adams (tadams) would appear with the “T”s.
Keep the primary completion date current.
This is an important date for ClinicalTrials.gov– your study may end up on the “problem list” if the date is not current.
Observational: Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.
Interventional: Studies in human beings in which individuals are assigned based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic, or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.
Expanded Access: Records describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. Expanded access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access, and parallel track.
Definitions from: https://register.clinicaltrials.gov/prs/html/definitions.html
Outcome measure information:
Please be as specific as possible.
For guidance see page 3 of:http://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf.
This outcome measure is a problem because the title and time frame are not specific enough.
How will the study measure nausea?
When will it be measured, specifically?
If these fields are not clear, the study registration will get comments from the QA reviewers, and could be delayed.
This outcome measure is now much more specific and provides a specific time when it will be measured.
Notice that additional information is provided about the nausea scale: the range, what the beginning and end of the scale mean, and the definition of “improved.”
* Note: Secondary Outcome Measure fields require same information
If the same intervention (e.g., drug) is used in multiple arms, enter information about the intervention only once, even if the dosage is different.
Use the Cross-Reference section to specify which arm the intervention is associated with.
Note: Please fill this section in completely. This information will give participants the correct information on whom to contact.
Completed all fields and Ready to Release your study on ClinicalTrials.gov
Please ensure you have thoroughly reviewed your study record…
Complete: The person updating the record will click on “Complete” to indicate that the study is ready for the “Approve” and “Release” actions.
Approve and Release: The Responsible Party of the study needs to click on “Approve” and “Release” for the record to be sent to ClinicalTrials.gov’s Quality Assurance (QA) group for review and to be published on the ClinicalTrials.gov website.
ClinicalTrials.gov does a manual review
5-7 business days.
You may receive some QA comments if the record is lacking required information, or if the information is not clear. The study registration will not receive an NCT number until these QA comments are resolved. Your record is not officially registered until an NCT# is assigned.
The searchable, public view of the database is at: www.clinicaltrials.gov
NOTE: ClinicalTrials.gov uses the “Record Verification Date” as the trigger for determining the next 6 month update.
PRS System identifies current ‘Problem Records’:
This slide set was made possible by a collaboration of CTSA organizations (Mayo Clinic, Partners HealthCare, University of Michigan Medical School, University of Rochester) and the National Library of Medicine.
The Clinical and Translational Science Awards Program (CTSA) is part of the Roadmap Initiative, Re-Engineering the Clinical Research Enterprise and is funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH).