How to Register a Clinical Trial
Contents
The system
- Data entry. Clinical trials are registered on the ClinicalTrials.gov site through a web-based data entry system called the Protocol Registration and Results System (PRS).
- Organizational account. An organization (e.g., the UW) has a single PRS organization account. The UW account is called UWashington.
- Organization account manager. The UWashington account is managed by HSD’s Regulatory Affairs team.
- Individual user accounts. Researchers or their staff must set up user accounts through the organization account. An individual’s user account may be used for more than one clinical trial.
Who can use the UW account
Any UW faculty, staff or student who is eligible to use the UW IRB for review of their studies may use the UW account to register their clinical trials, even for trials that were reviewed by a non-UW IRB instead of the UW IRB. Note that unless the UW is the prime recipient of the funding, this does not include individuals employed by:
- Valley Medical Center
- Any VA facility
- Any non-UW institution (for example, Bloodworks Northwest; Northwest Kidney Center; King County Seattle Public Health) for which the UW IRB is the IRB of record
Creating a user account
Read HSD’s SOP Creating a CT.gov User Account. The process takes up to 48 business hours.
General help documents
To assist researchers, HSD has linked to and downloaded these and other documents from the PRS site.
PRS Quick Start Guide: 2-page quick introduction to registering and maintaining records
PRS User’s Guide: 28-pages of step-by-step instructions for how to use PRS
PRS roles and responsibilities
Sponsor (or Sponsor Organization)
A company, university, medical center, or other research organization that conducts clinical trials. Each study record has a Sponsor Organization. Investigators apply to be users of the Sponsor Organization’s PRS account.
UW: The UW is a Sponsor Organization; it is listed in the PRS system as UWashington.
Administrator
Individual designated by the organization to manage the organization’s PRS account, create accounts for users, and serve as the point of contact for PRS staff. UW: HSD’s Regulatory Affairs team serves as the Administrator for the UWashington account. Contact them through hsdreprt@uw.edu.
User
Any PRS account holder who is authorized to enter information into the PRS, including investigators or research staff. Users create and modify their own records, but cannot access other users’ records unless authorized by the Record Owner or by an Administrator.
Record Owner
PRS account holder who creates a study record in the PRS. Record Owners can maintain the record themselves or give other users access to a record to make changes.
Responsible Party
Entity or individual responsible for verifying the accuracy of a study record and releasing it to ClinicalTrials.gov. UW: The PI should be identified as the Responsible Party.
Official Representative
The official contact person at the Sponsor Organization. UW: The Official Representative is the Director of the Human Subjects Division.
General workflow
View the general workflow diagram. This applies to: initial registration, record updates, record corrections, and results reporting.
Registering a Trial
This is called Protocol Registration by the PRS system. To start, log into the PRS system (https://clinicaltrials.gov/ct2/manage-recs/register) at Clinical Trials.gov, using the UWashington organization, your user name and password. Select Create New Record. Information is entered by completing a series of topic-specific modules. The following documents and links provide useful help:
- PRS Help: Protocol Modules. For each Protocol Module, this PRS document provides an introduction, examples, data entry tips, and a review checklist.
- PRS Protocol Registration Data Element Definitions. This PRS webpage provides definitions for each of the protocol registration data elements, and indicates whether each element is optional.
- PRS Review Criteria for Registration describes the criteria used by the PRS system to assess completeness and consistency of results reporting.
- WORKSHEET: Clinical Trial Registration was prepared by HSD for researchers. It lists the protocol modules and the specific data elements in each module. This allows the record creator to see in advance what specific information will be required, before going into the PRS system.
Helpful Tips
- Smart forms. The PRS data entry forms are “smart”. This means that some fields will appear (or not) depending upon your answers to other questions.
- Optional elements. A symbol indicates whether each data element is optional or required.
- Special characters, formatting tips. Read the PRS User’s Guide for formatting and special character information. For example: ≤ or ±
- One or multiple sessions. You do not need to complete the registration in one sitting.
- Downloading a copy of the record. Section 5.1 of the PRS User’s Guide describes how to download a RTF file of your record. This can then be imported into Microsoft Word (or another word processing program) – which is very useful for editing and sharing a record with co-workers.
- HIGHLY RECOMMENDED: Review what you have entered before you submit the record. Section 5.1 of the PRS User’s Guide describes several different ways to check your record. The PRS Protocol Review Criteria document is also useful.
Resolving Problems
Section 8 of the PRS User’s Guide describes how to identify and resolve records with problems. If you are unable to resolve the problem, contact HSD at hsdreprt@uw.edu for assistance. Put CT.gov in the subject line for efficient triage of your question.
Change of PI, Change of PI institution, or Changes to the Access List
Contact HSD at hsdreprt@uw.edu to request assistance with these situations. Put CT.gov in the subject line for efficient triage of your question.
Updating a Trial Record
Read How to Update a Clinical Trial Record.