Brief Overview of Clinical Trial Submission Process
We now have a web-based submission process to add a clinical trial to the Joint Clinical Trial Office (JCTO) website, remove a trial from the website, or to update existing clinical trial information (such as contact information or in light of an amendment to the trial). Please see steps and instructions below.
1. Check if a trial already exists and is up-to-date.
To ensure existing trial information is up-to-date, use the clinical trial search bar on the "Open Clinical Trials" page to search for your existing trial. You can search by trial title, IRB #, primary investigator (PI), or keywords related to the trial.
You may also browse for trials using the A-to-Z guide found on the open clinical trials page. The A-to-Z guide lists trials based on their disease category. Please note that each clinical trial can be listed under multiple categories if applicable.
2. Adding, Updating and Removing Clinical Trials
Requests to add a clinical trial to the Joint Clinical Trial Office (JCTO) website, remove a trial from the website, or to update existing clinical trial information (such as contact information or in light of an amendment to the trial), can be done by completing this form.
Use this link to add, update or remove a clinical trial: http://bit.ly/2k4hQoo
Please have the following key information readily available when completing the online form:
- Title (255 characters or less)
- WCMC IRB Protocol Number
- Sponsor/Alliance Protocol Number
- ClinicalTrials.gov Identifier Number
- Status of Trial (Open to enrollment, not yet accruing, closed)
- Trial Type (Interventional, observational, ancillary/correlative)
- Phase of Trial (pilot, 1, 2, 3, 4, other)
- Trial Audience (pediatric, adult, both)
- According to the FDA, is this trial considered to use a "Drug" or "Device"? (please
specify drug/device name)
- PI Full Name and credentials (MD, MPH, PhD, etc.)
- Link to PI’s POPs Profile (or VIVO profile if not a clinician)
- Study Contact
- Phone number
- Study Sponsor Name
- Study Summary (lay language overview of the purpose of the study and what it entails
using IRB-approved language)
- Key eligibility criteria (inclusion/exclusion, can also insert text that says “Detailed
criteria will be reviewed with the study team”)
To begin using the form, simply select the type of content you wish to add, update, or remove from the JCTO Website.
3. After submitting
Once the form has been received, your clinical trial submission will be reviewed and made available on the website within 5 business days. Once your clinical trial has been posted, you will receive a confirmation e-mail from the JCTO Subject Recruitment Team that includes the direct link to the trial. If the JCTO Subject Recruitment Team has any additional questions, we may follow up with you directly before posting the clinical trial details on the website.
If you have any additional questions, or any questions arise during the submission process, please contact email@example.com for further assistance.