Register Your Clinical Trial

No matter what type of human-subject research investigators may be working on, there are some steps that all should take to enhance patient recruitment. By posting studies on the following four websites, researchers can efficiently find the participants needed to complete projects in a timely fashion.

✔ REGISTER — ClinicalTrials.gov

http://clinicaltrials.gov/

Researchers may post any human-subject study to ClinicalTrials.gov — even observational studies — to benefit from a megaphone of publicity, all underwritten by the National Institutes of Health. ClinicalTrials.gov receives 50 million unique visitors a month, and its clinical trial data is regularly fed onto the Stanford Clinical Trials Directory, patient advocacy websites and the World Health Organization’s trials database, among others. The NIH has recently put more marketing muscle behind this database with the launch of a new website — www.cc.nih.gov/ — to promote clinical trial participation. (Remember that a certain class of interventional studies is required to be listed on ClinicalTrials.gov, and investigators must post these study results on the NIH site within a year after study completion.)

• Who is required to register a clinical trial with ClinicalTrials.gov?
• A Principal Investigator who holds the IND, IDE or NSR determination for a device.
• The Principal Investigator of an investigator-initiated clinical interventional study of drugs (Phases 2-4), biologics or devices, conducted at least in one site in the U.S., excluding multi-site studies where the Stanford PI is a subcontract recipient.
• For ICMJE journal publications, the Principal Investigator of an interventional study of any type, phase, or location.
• The Stanford Principal Investigator of an NIH-funded clinical intervention study of drugs (Phases 2-4), biologics or devices is responsible for registering the study (the subcontract PI is not responsible). For more information about this requirement, see http://grants.nih.gov/ClinicalTrials_fdaaa


• Failure to register with ClinicalTrials.gov
• May result in fines from NIH or FDA
• May prevent study publication


• How to register

• Register your clinical trial with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS).
• Returning users:
• Log in to PRS at http://prsinfo.clinicaltrials.gov/
• First-time users of PRS:
• You will need to obtain access to (PRS) before you can log in. One of the Stanford administrators listed below can grant you access to PRS and give you further instructions to get started.
• You can then log in to PRS at http://prsinfo.clinicaltrials.gov/to register your study.


• For information or assistance contact one of the Stanford administrators for ClinicalTrials.gov:
• Non-cancer Studies — Linda Walker  , (650) 498-6498 (Spectrum Operations, Training & Compliance)
• Cancer Clinical Trials Office — Cancer Clinical Trials Office  , (650) 724-0513

• Understand the Requirement — Helpful Links

• Clinicaltrials.gov Additional Information – PRS and U.S. Public Law 110-85
• Identifying an “ACT” (Applicable Clinical Trials)
• Identifying “Responsible Party"
• Elaboration of Definitions
• ClinicalTrial.gov Registration Policy Requirements
• Complete policy requirements
  Food and Drug Administration Amendments Act of 2007. Public Law 110-95.
• Laine C, Horton R, DeAngelis CD, et al. Clinical trial registration – looking back and moving ahead. N Engl J Med 2007;356:2734-6
• Guide to Results Data Entry (CHEST, 2009 Jul;136(1):295-303)

✔ APPROVE in CAP — Stanford Clinical Trials Directory

http://med.stanford.edu/clinicaltrials/

When you post your studies to ClinicalTrials.gov, your trials data is automatically downloaded to the Stanford Clinical Trials Directory each night. (Previously, researchers had to manually enter this data into the directory.)

Before a trial is posted to the public-view directory, the trials tool sends a notification to the lead investigator’s CAP (Community Academic Profile) inbox, in the same way that PubMed article notifications occur. At this time the researcher must approve and, if necessary, edit the imported trial description. If an investigator “accepts” a trial, it appears in both the Stanford Clinical Trials Directory and his or her public-view CAP academic webpage. In addition, researchers can manually add Stanford contact information for multicenter trials listings.

✔ ResearchMatch

https://www.researchmatch.org/

ResearchMatch is an NIH-funded resource that connects people who are trying to find research studies with researchers looking for study participants. This free matchmaking service is available for no charge to Stanford researchers because of its membership in the NIH’s Clinical and Translational Science Award consortium. For help with ResearchMatch, contact Peg Tsao, RN  

✔ REGISTER — FDA: IND and IDE Studies

http://clinicaltrials.gov/ct2/manage-recs/fdaaa

• The FDA requires registration.
• Registration must occur prior to enrollment of the first study participant.
• Failure to register applicable drug, device, or biologic studies can result in federal fines.
• Please see the ClinicalTrials.gov Protocol Registration System website.

✔ REGISTER — ICMJE (Int’l Committee of Medical Journal     Editors)

http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

• ICMJE requires registration.
• Registration must occur prior to enrollment of the first study participant.
• Without this registration, you run the risk of not being able to publish the results of your study.
• Please see the ICMJE website for information about this requirement. » More information – ICMJE website